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International Journal of Nursing Studies journal homepage: www.elsevier.com/ijns
Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial Haixia Gao a, Guihua Xu a,*, Honglian Gao b, Rongzhi Dong b, Hongjie Fu b, Danwen Wang a, Heng Zhang a, Hua Zhang a a b
School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China Binzhou Medical University Hospital, Binzhou, China
A R T I C L E I N F O
A B S T R A C T
Article history: Received 7 November 2014 Received in revised form 29 March 2015 Accepted 3 April 2015
Background: Preterm infants’ repeated exposure to painful procedures may lead to negative consequences. Thus, non-pharmacological pain management is essential due to medication side effects. Kangaroo Mother Care, which aims at offering human care to neonates, has been established for the treatment of a single painful procedure, but the effectiveness of Kangaroo Mother Care across repeated painful procedures is unknown. Objective: To test the effectiveness of repeated Kangaroo Mother Care on repeated heelstick pain in preterm neonates. Design: Randomized controlled trial. Setting: Level III Neonatal Intensive Care Unit at a large teaching hospital in northeast China. Method: Preterm infants (gestational age less than 37 weeks) (n = 80) were recruited and randomly assigned using a random table format to either an incubator group (n = 40) or Kangaroo Mother Care group (n = 40). Pain assessments were carried out during four routine heel stick procedures. For the first heel stick, preterm infants in each group received no intervention (routinely stayed in incubator). During the next three heel sticks, the infants in Kangaroo Mother Care group received heel sticks during Kangaroo Mother Care, while infants in the incubator group received heel sticks in incubator. The procedure of each heel stick included 3 phases: baseline, blood collection and recovery. Crying, grimacing and heart rate in response to pain were evaluated at each phase across four heel sticks by three trained independent observers who were blinded to the purpose of the study. Data were analyzed by analysis of variance (ANOVA), with repeated measures at different evaluation phases of heel stick. Results: 75 preterm infants completed the protocol. Between-group comparison revealed that preterm infants’ heart rate was significantly lower, and the duration of crying and facial grimacing were both significantly shorter in the Kangaroo Mother Care group (n = 38) than the incubator group (n = 37) from the blood collection phase to recovery phase during repeated heel sticks. No significant within-group difference was found in heart rate between the baseline phase and recovery phase through repeated heel sticks for Kangaroo Mother Care group. In contrast, the incubator group experienced significant
Keywords: Crying Heart rate Kangaroo-Mother Care Method Pain Preterm infants
* Corresponding author at: School of Nursing, Nanjing University of Chinese Medicine, 138 Xianlin Road, Qixia District, Nanjing, Jiangsu Province 210023, China. Tel.: +86 25 85811639. E-mail address: [email protected] (G. Xu). http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006 0020-7489/ß 2015 Elsevier Ltd. All rights reserved.
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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within group differences in heart rate between baseline and recovery through repeated heel sticks. Conclusion: The effect of repeated Kangaroo Mother Care analgesia remains stable in preterm infants over repeated painful procedures. Given the many invasive procedures that are part of clinical care in preterm infants and most mothers preferred to provide comfort for their infants during painful procedures, Kangaroo Mother Care may be a safe analgesic alternative in preterm infants in whom it is feasible. ß 2015 Elsevier Ltd. All rights reserved.
What is already known about the topic? Hospitalization in neonatal intensive care units is required by the preterm infants; various diagnostic, surgical, or therapeutic procedures could be unpreventable and resulted in pain experiences. Exposure to repeated neonatal pain-related stress may lead to poorer cognitive, motor, and behavioral neurodevelopment in infants and children born very preterm. Kangaroo Mother Care, as one non-pharmacological method, has been established for the treatment of a single painful procedure, but the effectiveness of Kangaroo Mother Care across repeated painful procedures is unknown. What this paper adds The effect of repeated Kangaroo Mother Care analgesia remains stable in preterm infants over repeated painful procedures. Kangaroo Mother Care facilitated preterm infants’ behavioral and physical responses to return to the baseline phase more quickly than incubator care after repeated painful procedures. 1. Introduction The World Health Organization (WHO) reports that 15 million babies are prematurely born annually in the world (WHO, 2014). China contributes to 7.8% of these global preterm births, second only to India which is at the top of the list at 23.6% (Blencowe et al., 2012). Zhao and colleagues (2011) reported a 14% increase in preterm births from 2005 to 2009 in China; it is predicted more than 1.5 million preterm births will occur in China by 2015 (Zhao et al., 2012). Hospitalization in neonatal intensive care units (NICU) is required by preterm infants; however, various unpreventable therapeutic procedures could result in pain experiences for neonates (Evans et al., 2005; Lago et al., 2005). Neonatal rat models have demonstrated that persistent or repeated pain experiences increase apoptosis of neurons, and neonatal pain and stress lead to anxietylike behaviors during adulthood (Knaepen et al., 2013). Among preterm infants and children, repeated exposure to neonatal pain-related stress has been associated with altered brain microstructure and stress hormone levels, and poorer cognitive, motor, and behavioral neurodevelopment (Vinall and Grunau, 2014). Thus, pain management is a critical issue in current neonatal practice.
Preterm infants’ pain might not be effectively managed by opioids (Axelin et al., 2009; Carbajal et al., 2005), and pharmacological pain management may not be ideal due to medication side effects (Anand et al., 2004). Therefore, non-pharmacological pain management for preterm infants is essential in neonatal practice for pain management. One inexpensive and safe non-pharmacological strategy, which would also provide mothers an opportunity to comfort their infant during painful procedures in a technologically invasive environment, is Kangaroo Mother Care. Kangaroo Mother Care is operationally defined as the upright prone positioning of the diaper-clad infant, skinto-skin and chest-to-chest with an adult. The Kangaroo Mother Care method, which is aimed at offering human care to neonates, has been formally endorsed by the WHO (Department of Reproductive Health and Research, 2003). Many randomized controlled trials examining the management of pain during heel sticks and vaccinations have found Kangaroo Mother Care to have an analgesic effect on neonates (Akcan et al., 2009; Castral et al., 2008; Cong et al., 2009, 2011, 2012; Freire et al., 2008; Johnston et al., 2003, 2008, 2009; Kostandy et al., 2008; Ludington-Hoe et al., 2005; Nimbalkar et al., 2013; Okan et al., 2010; Saeidi et al., 2011). Furthermore, a recent systematic review concluded that skin to skin care appears to be effective and safe for a single painful procedure such as a heel stick (Johnston et al., 2014). However, there have been no studies examining the effectiveness of Kangaroo Mother Care across repeated painful procedures. Therefore, the purpose of this study was to determine if the analgesic effect changed with repeated Kangaroo Mother Care used in repeated painful events. We hypothesized that the effect of repeated Kangaroo Mother Care analgesia remains stable over repeated painful procedures. Behavioral and physiological outcomes are important to measure because they characterize preterm infants’ responses to pain. Young preterm infants often respond to pain differently in behavioral and physiologic measures (Cong et al., 2012; Sellam et al., 2011). Behavioral indicators for pain could include facial activity, cry, body movements and resting positions, fussiness/consolability, and sleeplessness. Crying is a common response to pain in infants (Gibbins and Stevens, 2001) and is considered to be a sensitive method for assessment of pain (Stevens et al., 2006). Some preterm and acutely ill infants may not cry during painful procedures, which may be due to depleted energy reserves, or an inability to cry because of the presence of an endotracheal tube (Johnston et al., 1999;
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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Ludington-Hoe et al., 2005). In the absence of crying (and with crying), the infant may exhibit ‘‘grimacing’’ (brow bulge, eye squeeze, and nasolabial furrowing). Grimacing has been reported in 99% of neonates exposed to heel sticks and is believed to be a very sensitive indicator of infant pain (Grunau and Craig, 1987; Grunau et al., 1990; Hadjistavropoulos et al., 1994). Physiological indicators for pain could include changes in heart rate, respiratory rate, oxygen saturation, and blood pressure. Heart rate (HR) is one of the most studied physiological pain indicators. For this study, we chose crying and grimacing as the behavioral indicators, and HR as the physiological indicator for neonatal pain.
2. Methods 2.1. Design This randomized controlled trial examined the effectiveness of 30-minute Kangaroo Mother Care on preterm infants’ behavioral and physiological responses to pain before and throughout three nonconsecutive routine heel sticks. Preterm infants were randomly assigned using a random table format to either an incubator group or Kangaroo Mother Care group. 2.2. Setting and sample Preterm infants were recruited from a level III NICU at a large teaching hospital in northeast China from May 2012 to October 2013. The inclusion criteria were infants: (1) singleton with gestational age less than 37 weeks, (2) cared for in an incubator, (3) anticipated to have at least four routine capillary blood draws within 2 weeks after birth, and (4) not scheduled to receive paralytic, analgesic, or sedative medications 48 h prior to a study session. Infants were excluded if they had any of the following conditions: congenital or neurological anomalies, grade III or IV intraventricular hemorrhage, surgery, signs of heel tissue breakdown or inflammation/necrosis, medically unstable, required oxygen or respiratory support, or mother had a history of drug abuse during pregnancy. In our pilot study, we found the average crying time during heel sticks for 15 preterm infants was 67.9 s (SD = 13.1). To detect a mean difference of 10 s in crying time during heel sticks between our two study groups, a power of 0.90, alpha of 0.05, and a 10% attrition rate was used to determine our estimated sample size of 80 preterm babies. 2.3. Conditions in incubator and Kangaroo Mother Care groups Condition in the incubator group: The infant, wearing only a diaper, was placed prone in the incubator at a 30– 408 incline to resemble the Kangaroo Mother Care position and remained undisturbed for 30 min before blood collection by heel stick, and then blood collection, and then the recovery phase were executed while the infant remained in the incubator in the same position. Mothers were not present during the incubator periods.
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Condition in the Kangaroo Mother Care group: Infants in the Kangaroo Mother Care group were given Kangaroo Care by their mothers in 30 min before, and throughout the recovery phase of the heel stick. With the guidance of a trained NICU nurse, the procedures of Kangaroo Mother Care are conducted by mothers as follows: Step 1: mother changed into a front-buttoning hospital gown and sat in her bed nearby the incubator, reclining at a 458angle. Step 2: the infant, naked except for his diapers, was transferred by the NICU nurse from the incubator to his mother’s breasts so that skin-to-skin contact was maintained through the open gown. Step 3: infant was covered with a blanket. Step 4: the mothers and infants were left for 30 min to allow them to rest comfortably in this skin-toskin contact position before blood collection by heel stick, and then blood collection, and then the recovery phase were executed in the Kangaroo Mother Care condition. After the procedure, the preterm infants were transferred back to an incubator or remained in the Kangaroo Mother Care condition if the mother preferred. 2.4. Measures 2.4.1. Measurement of behavioral pain indicator Behavioral pain indicators included: (1) duration of crying across the blood collection phase and recovery phase, and (2) duration of grimacing during the blood collection phase and recovery phase. The total duration of crying occurred respectively in blood collection phase and the recovery phase was monitored by using a digital audio recorder (MODEL F97) and calculated from all crying bouts, which were from the beginning of crying vocalization to the end of crying for 5 s or more (Ludington-Hoe et al., 2005). The total duration of grimacing was calculated in the same method as for crying by using video recording. Videotaping for the whole heel stick process, the research assistant (RA) coded it and downloaded it onto the personal computer, then one assessor who was unaware of the purpose of the study timed the duration of cry using the Lorus stopwatch to the nearest tenth of a second. At the blood collection phase of the first heel stick, all of the crying recordings (n = 80) were timed respectively by the assessor and the first author then crossexamined to ensure acceptable inter-rater agreement. The inter-rater reliability for the duration of crying between the evaluator and the first author was 98%. Intra-rater reliability was checked every 3 months, remaining more than 90%. Grimacing was defined as brow bulge, eye squeeze, and nasolabial furrowing occurring simultaneously and continuing 5 s or more, which was videotaped using a digital camera (Canon sx30is) by the RA. The camera was in closeup focus on the neonate’s face, with little surrounding area, no sound, and minimal color, and turned to an angle in the Kangaroo Mother Care condition as to mimic the prone position, in order to decrease the possibility of unblinding by the assessor who evaluated the grimacing response. The videotape of grimacing was coded and downloaded onto the personal computer by the RA, and then was evaluated by one trained assessor who could stop or restart the
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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videotape as many times as needed to establish the duration second by second. The methods we used to calculate the duration of grimacing in the blood collection phase and recovery phase, and the inter-rater agreement for grimacing between the first author and the assessor were respectively the same as for crying. The inter-rater reliability for the duration of grimacing at the blood collection phase of the first heel stick between the investigator and the evaluator was 97%. Intra-rater reliability for every assessment was checked every 3 months, remaining more than 90%.
two assessors evaluated infants’ crying and grimacing respectively (see Section 2.4.1). All personnel were trained separately by the first author. The first author, who knew the research purpose and protocol, was responsible for collecting infants’ demographic data and number of previously invasive procedures by reviewing medical records and nurses’ daily notes. Study fidelity was established by weekly meetings between the investigators and physician assistant.
2.4.2. Measurement of physiological indicator Physiological response to the painful stimulus was measured by the change in heart rate (HR) by using a continuously displaying in electrocardiogram monitor. The HR leads were attached to the infant’s chest, HR values were digitally sampled at 30-s interval by computer and were manually recorded by a nurse student. At the end of the study, the nurse student calculated the mean HR throughout baseline, blood collection and recovery phases of each heel stick procedure by personal computer through averaging the displaying data over 30 s.
SPSS version 19.0 software package was used in data analysis. Data were described using means and standard deviations for continuous variables and frequencies for categorical data. For comparisons among the three phases, measurement indicators (the duration of crying and grimacing, heart rate) across the subsequent three heel sticks were averaged separately. Variables were compared both within- and between-groups at different evaluation phases by using ANOVA, including one or two factors, both with repeated measures. If there was an interaction between conditions and evaluation phases, a simple main effect test was used. Tests of between or within-group post hoc simple effects were performed with Bonferroni corrections. The level of significance was set to 5% (p < 0.05) for all comparisons.
2.5. Procedures This study was approved by the institutional review board at the study site. One RA screened admission log every other day in the NICU, and finalized potential eligible infants, and explained and obtained oral consent from both parents. The procedure of each heel stick included three phases: (1) Baseline: one minute of baseline was collected at the end of the 30 min in the assigned condition, that is following 30 min of Kangaroo Mother Care or in incubator. (2) Blood collection: including antisepsis, heel stick, possible further squeezes and adhesive bandage applied to the site for hemostasis after blood was drawn, it lasted 1.5 min when (68 [90%] of 75) most procedures had been completed. (3) Recovery: 2 min following blood collection. For the first heel stick, each infant received with no intervention (routinely stayed in incubator), in order to observe the individual patterns of behavioral and physiological responses of the infants during the heel stick procedure. During the next three heel sticks, the infants in Kangaroo Mother Care group received heel sticks during Kangaroo Mother Care, while infants in the incubator group received heel sticks in incubator. Because the timing of blood sampling was determined by clinical needs, there were no fixed time points for data collection. Most heelstick events took place in the morning and the intervals of them ranged from 3 to 48 h. In order to coordinate the Kangaroo Mother Care procedure with mother’s visit, on the day before the infant was scheduled for blood draw by heel stick, one RA contacted mother to notify her of the session. The behavioral indicators (crying and grimacing) were collected by one RA and the physiological indicator data (heart rate) was collected by a nursing student. Heel stick procedures were performed by a physician assistant. The whole heel stick process was videotaped and coded, then
2.6. Data analysis
3. Results A total of 128 infants were screened, 97 met the criteria and were approached, and 80 agreed to participate. The reasons for refusal were: parents refused to videotape their infants due to their small size (n = 5), mothers did not want to do Kangaroo Mother Care (n = 5), mothers did not want the neonates to cry on her (n = 4), mother was too ill (n = 1), and the family lived too far to come in (n = 2). Only 75 had completed data, five infants dropped out because they were discharged prior to the required heel-sticks (see Fig. 1). The demographic data and the number of previously invasive procedures performed on preterm infants before the present study in incubator and Kangaroo Mother Care groups are presented in Table 1. There were no statistically significant differences in any of these above data between the two groups (p > 0.05). 3.1. Comparison of preterm infants’ behavioral and physical pain responses to the first heel stick (each group received no intervention) between incubator group and Kangaroo Mother Care group The ANOVA revealed that no significant interactions were found regarding the duration of crying (F = 0.821, p = 0.406), duration of grimacing (F = 0.525, p = 0.527) and heart rate (F = 0.683, p = 0.456) between conditions and evaluation phases. Moreover, there was no significant main effect between conditions for the three measured indicators (crying: F = 0.015, p = 0.904; grimacing: F = 1.662, p = 0.201; heart rate: F = 0.007, p = 0.936) (Table 2).
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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Assessed for eligibility (n=128)
Excluded (n =48) Meeting exclusion criteria (n =31) Refused to participate (n = 17)
n =80 Randomly allocated
Allocated to control (n=40)
Allocated to intervention (n = 40)
In the all four inconsecutive heel sticks,
In heel stick 1: infants received allocated
infants received allocated incubator condition
incubator condition exactly same as control
Heel stick 1 (n=40)
group; In heel stick 2, 3 and 4, infants
Heel stick 2 (n=39): 1 infant discharged prior
received allocated Kangaroo Mother Care
to second heel stick
condition.
Heel stick 3 (n=39)
Heel stick 1 (n=40)
Heel stick 4 (n=37): 2 infants discharged prior
Heel stick 2 (n=40)
to fourth heel stick
Heel stick 3 (n=39): 1 infant discharged prior to third heel stick Heel stick 4 (n=38): 1 infant discharged prior to fourth heel stick
Analyzed
Analyzed Repeated four heel sticks (n=37)
Repeated four heel sticks (n=38)
Fig. 1. Flow diagram of the recruitment and randomization process.
3.2. Comparison of preterm infants’ behavioral and physical pain responses to the repeated three heel sticks between incubator group and Kangaroo Mother Care group 3.2.1. Between-group differences in behavioral and physical pain responses during the repeated three heel sticks The ANOVA results showed significant interactions of the duration of crying (F = 48.955, p = 0.000, partial eta = 0.401) and grimacing (F = 28.858, p = 0.000, partial eta = 0.283) except heart rate (F = 1.858, p = 0.167) between conditions and evaluation phases. Between-group comparisons revealed that preterm infants’ heart rate was significantly lower, the duration of crying and facial grimacing were both significantly shorter in the Kangaroo
Mother Care group than the incubator group from the blood collection phase to recovery phase (Table 3). Moreover, there were more infants without crying (88%) or grimacing (86%) in the Kangaroo Mother Care group than in the incubator group (40% and 31% respectively) during the recovery phase. 3.2.2. Within-group differences in behavioral and physical pain responses during the repeated three heel sticks Crying, facial grimacing and heart rate showed similar patterns in incubator and Kangaroo Mother Care groups, namely increasing significantly followed by blood collection phase and decreasing afterwards. Within-group comparison revealed that there was significant difference
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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Table 1 Comparisons of demographic data and number of previously invasive procedures between groups. Variable Gestational age, week 27–29a 30–34a >34a Gender Malea Femalea Method of delivery Vaginal deliverya Cesarean deliverya Birth weight, gb Gestational age at birth, weekb 5-minute Apgar scoreb Postnatal days Heel stick 1b Heel stick 2b Heel stick 3b Heel stick 4b Previous invasive proceduresb Duration of blood collection phase (s) Heel stick 1b Heel stick 2b Heel stick 3b Heel stick 4b
Incubator group
Kangaroo Mother Care group
p-Value
2 32 3
3 32 3
0.911
19 18
18 20
0.730
12 25 2030.0 135.6 33.3 1.6 7.2 1.5
15 23 2017.8 154.7 33.8 1.1 7.7 2.1
0.525 0.718 0.106 0.220
3.6 0.4 4.2 0.8 5.2 0.7 6.8 0.8 15.3 2.7
3.5 0.3 4.3 0.8 5.3 0.6 6.7 0.8 16.0 2.1
0.265 0.697 0.742 0.401 0.230
83.1 11.1 66.4 11.3 65.8 10.7 76.9 16.8
80.2 8.6 67.3 14.0 65.3 17.0 77.4 16.6
0.216 0.751 0.887 0.908
Note: a n. b Mean (standard deviation).
in the duration of both crying and grimacing between the baseline and recovery phases for the incubator group (p < 0.0001; p < 0.0001) and the Kangaroo Mother Care group separately (p = 0.008; p = 0.003) (Table 4). Significant differences were not found in heart rate between the baseline phase and recovery phase for the Kangaroo Mother Care group (p = 0.820). However, for the incubator group, heart rates remained significantly faster in the recovery phase compared to baseline phase (p = 0.004) (Table 4). In other words, in recovery phase, Kangaroo Mother Care group’s heart rate had returned to the baseline phase, while the incubator group’s heart rate had been still significantly faster than in the baseline phase. 4. Discussion Heel stick is a very common specimen collection method in NICU, and our study showed heel stick caused
pain evidenced by heart rate increased, crying and grimacing. There are substantial studies presenting short-term and long-term adverse neuro-developmental consequences of painful procedures (Hohmeister et al., 2009, 2010; Slater et al., 2010). The present study compared the impact of repeated Kangaroo Mother Care and incubator care on behavioral and physiological pain responses to repeated heel sticks in preterm infants. Regarding the heart rate, crying and grimacing responses, a significant difference in the three indicators was observed between the groups, with these indicators being smaller in the Kangaroo Mother Care group compared to the incubator group across the repeated heel sticks. The findings of efficacy of Kangaroo Mother Care in crying, grimacing and heart rate responses were in accordance with those of the previous studies conducting a single heel stick. Kostandy et al. demonstrated that preterm infants in Kangaroo Care 30 min had less crying
Table 2 Comparison of pain responses to the first heel stick (each group with no intervention). Baselinea Crying (s) Incubator group Kangaroo Mother Care group Grimacing (s) Incubator group Kangaroo Mother Care group HR (beats/min) Incubator group Kangaroo Mother Care group
Blood collectiona
Recoverya
0 0
63.5 9.0 65.7 6.6
16.8 16.5 15.2 15.5
0 0
78.1 8.1 75.0 7.9
18.9 16.7 16.5 15.9
165.4 11.8 167.1 10.2
160.9 10.1 160.9 9.3
149.3 13.3 147.2 16.2
Note: Data are listed as mean SD. HR: heart rate. a Mean (standard deviation).
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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Table 3 Between-group comparison of pain responses to the repeated three heel sticks. Baselinea Crying (s) Incubator group Kangaroo Mother Care group Between-groups Pb Grimacing (s) Incubator group Kangaroo Mother Care group Between-groups Pb HR (beats/min) Incubator group Kangaroo Mother Care group Between-groups Pb
Blood collectiona
Recoverya
0 0 –
60.4 8.9 34.3 16.6 p < 0.0001c
12.7 10.9 0.9 1.7 p < 0.0001c
0 0 –
62.3 8.9 40.3 18.9 p < 0.0001c
14.8 11.1 1.1 1.9 p < 0.0001c
162.0 10.5 154.4 10.2 0.002c
152.8 8.4 144.9 9.5 p < 0.0001c
146.4 11.8 143.1 10.0 0.194
Note: Data are listed as mean SD. HR: heart rate. a Mean (standard deviation). b Bonferroni correction for multiples comparisons. c p < 0.05
infants, Kangaroo Mother Care infants’ mean duration of crying and grimacing in the recovery phase were near to baseline phase durations, although statistical significances were both found between the baseline phase and the recovery phase. Moreover, most infants in the Kangaroo Mother Care group had no crying (88%) or grimacing (86%) during the recovery phase. In addition, infants’ HR in the Kangaroo Mother Care group at the recovery phase had returned to the baseline phase. The results of this study indicate that Kangaroo Mother Care can facilitate not only a diminished response, but also a quicker recovery in infants, which was consistent with the previous reports (Castral et al., 2008; Johnston et al., 2008, 2011; Shah and Jefferies, 2012). The ability to recover quickly is a sign of ability to maintain homeostasis, a major task that the very preterm neonate must accomplish in order to grow and develop (Moore and Anderson, 2007). The strengths included in the present study are: (1) We have controlled for contextual factors associated with pain response of preterm infants in different study groups. Factors such as past painful procedures, gender, mechanical ventilation, APGAR scores, gestational age, birth weight, postnatal days may all affect response to pain. The two groups did not differ in terms of the above data indicating
time during the heel stick and recovery phases (Kostandy et al., 2008). Ludington-Hoe et al. reported that heart rate and crying responses to pain were significantly reduced in preterm newborns given 3 h of Kangaroo Care before a heel stick (Ludington-Hoe et al., 2005). In a study conducted on 95 preterm neonates, Freire et al. observed a reduction in heart rate variation and duration of facial actions across 30 s after the heel-lancing procedure in infants held in Kangaroo Care (Freire et al., 2008). The result from Okan et al. study showed that heart rate, oxygen saturation changes, length of crying and grimacing were significantly reduced in healthy term neonates with skin-to-skin contact undergoing heel-lance than infants who were lying on the table (Okan et al., 2010). A study comparing pain responses of preterm neonates who were receiving 15-minute Kangaroo Mother Care with infants who were receiving routinely incubator care during heel stick found that Kangaroo Mother Care statistically decreased infants’ heart rate, behavior and facial scores (Nimbalkar et al., 2013). Perhaps more importantly, was the significantly reduced time to recovery. Of clinical interest on procedural pain in preterm infants are response, that is the degree to which they respond; and recovery, how quickly they return to baseline state. Compared to incubator group
Table 4 Within-group comparison of pain responses to the repeated three heel sticks. Baselinea Crying (s) Incubator group Kangaroo Mother Care group Grimacing (s) Incubator group Kangaroo Mother Care group HR (beats/min) Incubator group Kangaroo Mother Care group
Blood collectiona
Recoverya
p (one-way RM ANOVA)
0b,c 0b,d
60.4 8.9 34.3 16.6
12.7 10.9 0.9 1.7
p < 0.0001 p < 0.0001
0b,c 0b,d
62.3 8.9 40.3 18.9
14.8 11.1 1.1 1.9
p < 0.0001 p < 0.0001
146.4 11.8b,c 143.1 10.0b,e
162.0 10.5 154.4 10.2
152.8 8.4 144.9 9.5
p < 0.0001 p < 0.0001
Note: Data are listed as mean SD. HR: heart rate. a Mean (standard deviation). b Bonferroni correction for multiples comparisons. c Significant difference when compared with recovery–incubator group (p < 0.05). d Significant difference when compared with recovery–Kangaroo Mother Care group (p < 0.05). e No significant difference when compared with recovery–Kangaroo Mother Care group (p > 0.05).
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uniformity of the sample analyzed. In addition, severity of illness can affect the infant’s ability to mount a response to pain. Severity of illness was not measured in this study, however all eligible infants were medically stable, not requiring oxygen or respiratory support, according to the protocols of the units at the time the study began. (2) The strategies undertaken to enhance the internal validity of these results. The use of 1 person conducting all heel sticks, the work of videotaping and evaluating of behavioral response are performed by different people. (3) Physiological response was measured every 30 s and collected accurately by computer. (4) In order to arrive at a better understanding of the data obtained, the preterm infants’ pain response patterns were established prior to interventions. Despite its strengths, this study had some limitations as follows: (1) The behavioral state of the infants before heel stick was not collected in the present study. Thus, we were unable to determine if the baby was in a homeostatic state at baseline, which may have influenced the pain responses, especially heart rate. (2) The grimacing evaluating procedure could not be completely blind to Kangaroo Mother Care conditions because maternal respiratory movements may move the infant’s face up and down in the video, as reported by other researchers (Johnston et al., 2008; Ludington-Hoe et al., 2005). (3) It was impossible to blind the physician assistant conducting the heel stick procedure, so that he may have been gentler during Kangaroo Mother Care condition, which was previously reported by Johnston et al. (2008). (4) Most infants eligible for the study were of a gestational age 33–34 weeks, which did not allow for appropriate analysis by gestational age due to subgroups being too small. Future studies could measure the infant’s behavioral state before painful procedures, in order to avoid its possible confounding effect on pain response. Infants in this study were all medically stable, future studies could examine the effect of repeated Kangaroo Mother Care on repeated procedural pain for medically unstable infants. Furthermore, the present study focused on the behavioral and physiological changes caused by heel sticks in order to provide a detailed analysis over the entire sampling period. Future research could use a composite pain tool such as Premature Infant Pain Profile (PIPP) or N-PASS to examine the effectiveness of Kangaroo Mother Care on the overall changes in the summary scores. In addition, the comparison of pain-relief effects between Kangaroo Mother Care and other non-pharmacological interventions can be examined during repeated painful procedures. Further research needs to compare whether there is difference in the effectiveness of repeated use of Kangaroo Mother Care between infants with different gestational ages. 5. Conclusions The results of this randomized controlled trial provide evidence that a 30-minute Kangaroo Mother Care remains effective in reducing heel-stick pain across at least three heel stick procedures. Given most mothers agreed to perform Kangaroo Mother Care in the study and the number of invasive procedures, especially heel-stick
procedure, is high, based on the results of the present study, it appears reasonable to offer the option of kangaroo care to mothers who want to provide comfort to their stable preterm infant during repeated painful procedures. It is therefore important for neonatal staff to contact mothers and notify them in advance that the infant is scheduled for blood draws and other painful procedures. When it is impossible to have mothers present for each painful procedure, the neonatal staff may apply other alternative non-pharmacological methods such as sucrose to preterm infants. Acknowledgments We appreciated very much to all of the participants and their parents in this study. The Preponderant Discipline Project of Universities in Jiangsu Province for grant support (YSHL0503-01). Finally, we gratefully acknowledged Professor S.Y. Lee and Jiayun Xu for their writing assistance. Conflict of interest. None declared. Funding. Funded by the Preponderant Discipline Project of Universities in Jiangsu Province, Nursing Science Open Fund of Nanjing University of Chinese Medicine (YSHL0503-01). Ethical approval. Human subjects approval was obtained from Binzhou Medical University Hospital, Binzhou, China. References Akcan, E., Yig˘it, R., Atici, A., 2009. The effect of kangaroo care on pain in premature infants during invasive procedures. Turk. J. Pediatr. 51 (1), 14–18. Anand, K.J., Hall, R.W., Desai, N., Shephard, B., Bergqvist, L.L., Young, T.E., Boyle, E.M., Carbajal, R., Bhutani, V.K., Moore, M.B., Kronsberg, S.S., Barton, B.A., NEOPAIN Trial Investigators Group, 2004. Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial. Lancet 363 (9422), 1673– 1682. Axelin, A., Salantera¨, S., Kirjavainen, J., Lehtonen, L., 2009. Oral glucose and parental holding preferable to opioid in pain management in preterm infants. Clin. J. Pain 25 (2), 138–145. Blencowe, H., Cousens, S., Oestergaard, M.Z., Chou, D., Moller, A.B., Narwal, R., Adler, A., Vera Garcia, C., Rohde, S., Say, L., Lawn, J.E., 2012. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet 379 (9832), 2162–2172. Carbajal, R., Lenclen, R., Jugie, M., Paupe, A., Barton, B.A., Anand, K.J., 2005. Morphine does not provide adequate analgesia for acute procedural pain among preterm neonates. Pediatrics 115 (6), 1494–1500. Castral, T.C., Warnock, F., Leite, A.M., Haas, V.J., Scochi, C.G., 2008. The effects of skin-to-skin contact during acute pain in preterm newborns. Eur. J. Pain 12 (4), 464–471. Cong, X., Cusson, R.M., Walsh, S., Hussain, N., Ludington-Hoe, S.M., Zhang, D., 2012. Effects of skin-to-skin contact on autonomic pain responses in preterm infants. J. Pain 13 (7), 636–645. Cong, X., Ludington-Hoe, S.M., McCain, G., Fu, P., 2009. Kangaroo care modifies preterm infant heart rate variability in response to heel stick pain: pilot study. Early Hum. Dev. 85 (9), 561–567. Cong, X., Ludington-Hoe, S.M., Walsh, S., 2011. Randomized crossover trial of kangaroo care to reduce biobehavioral pain responses in preterm infants: a pilot study. Biol. Res. Nurs. 13 (2), 204–216. Department of Reproductive Health and Research, 2003. Kangaroo Mother Care: A Practical Guide, 1st ed. World Health Organization, Geneva. Evans, J.C., McCartney, E.M., Lawhon, G., Galloway, J., 2005. Longitudinal comparison of preterm pain responses to repeated heelsticks. Pediatr. Nurs. 31 (3), 216–221. Freire, N.B., Garcia, J.B., Lamy, Z.C., 2008. Evaluation of analgesic effect of skin-to-skin contact compared to oral glucose in preterm neonates. Pain 139 (1), 28–33.
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Lago, P., Guadagni, A., Merazzi, D., Ancora, G., Bellieni, C.V., Cavazza, A., Pain Study Group of the Italian Society of Neonatology, 2005. Pain management in the neonatal intensive care unit: a national survey in Italy. Paediatr. Anaesth. 15 (11), 925–931. Ludington-Hoe, S.M., Hosseini, R., Torowicz, D.L., 2005. Skin-to skin contact (Kangaroo Care) analgesia for preterm infant heel stick. AACN Clin. Issues 16 (3), 373–387. Moore, E.R., Anderson, G.C., 2007. Randomized controlled trial of very early mother-infant skin-to-skin contact and breastfeeding status. J. Midwifery Womens Health 52 (2), 116–125. Nimbalkar, S.M., Chaudhary, N.S., Gadhavi, K.V., Phatak, A., 2013. Kangaroo mother care in reducing pain in preterm neonates on heel prick. Indian J. Pediatr. 80 (1), 6–10. Okan, F., Ozdil, A., Bulbul, A., Yapici, Z., Nuhoglu, A., 2010. Analgesic effects of skin-to-skin contact and breastfeeding in procedural pain in healthy term neonates. Ann. Trop. Paediatr. 30 (2), 119–128. Saeidi, R., Asnaashari, Z., Amirnejad, M., Esmaeili, H., Robatsangi, M.G., 2011. Use of Kangaroo Care to alleviate the intensity of vaccination pain in newborns. Iran J. Pediatr. 21 (1), 99–102. Sellam, G., Cignacco, E.L., Craig, K.D., Engberg, S., 2011. Contextual factors influencing pain response to heelstick procedures in preterm infants: what do we know? Eur. J. Pain 15 (7), 661. Shah, V., Jefferies, A., 2012. Preterm infants receiving heel lance procedures have slightly lower pain scores and quicker time to return to baseline heart rate when held in kangaroo care by the mother than by the father. Evid. Based Med. 17 (5), 153–154. Slater, R., Fabrizi, L., Worley, A., Meek, J., Boyd, S., Fitzgerald, M., 2010. Premature infants display increased noxious-evoked neuronal activity in the brain compared to healthy age-matched term-born infants. Neuroimage 52 (2), 583–589. Stevens, B., McGrath, P., Yamada, J., Gibbins, S., Beyene, J., Breau, L., Camfield, C., Finley, A., Franck, L., Howlett, A., Johnston, C., McKeever, P., O’Brien, K., Ohlsson, A., 2006. Identification of pain indicators for infants at risk for neurological impairment: a Delphi consensus study. BMC Pediatr. 2 (6), 1. Vinall, J., Grunau, R.E., 2014. Impact of repeated procedural painrelated stress in infants born very preterm. Pediatr. Res. 75 (5), 584–587. World Health Organization. http://www.who.int/mediacentre/ factsheets/fs363/en/ (accessed 01.09.14). Zhao, X., Chen, Y., Qiu, G., Xiao, M., Zhong, N., 2012. Reducing preterm births in China. Lancet 380 (9848), 1144–1145. Zhao, X.-L., Zhong, N., China Preterm Clinical Research Consortium, 2011. Retrospective study of 1,094,807 newborns showed the national average rate of preterm birth in China is 5.5%, which has been increased 14% from 2005 to 2009.In: Presentation at the 5th International Conference of Birth Defects in Developing Countries, October, Lodz, Poland.
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Contents lists available at ScienceDirect
International Journal of Nursing Studies journal homepage: www.elsevier.com/ijns
Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial Haixia Gao a, Guihua Xu a,*, Honglian Gao b, Rongzhi Dong b, Hongjie Fu b, Danwen Wang a, Heng Zhang a, Hua Zhang a a b
School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China Binzhou Medical University Hospital, Binzhou, China
A R T I C L E I N F O
A B S T R A C T
Article history: Received 7 November 2014 Received in revised form 29 March 2015 Accepted 3 April 2015
Background: Preterm infants’ repeated exposure to painful procedures may lead to negative consequences. Thus, non-pharmacological pain management is essential due to medication side effects. Kangaroo Mother Care, which aims at offering human care to neonates, has been established for the treatment of a single painful procedure, but the effectiveness of Kangaroo Mother Care across repeated painful procedures is unknown. Objective: To test the effectiveness of repeated Kangaroo Mother Care on repeated heelstick pain in preterm neonates. Design: Randomized controlled trial. Setting: Level III Neonatal Intensive Care Unit at a large teaching hospital in northeast China. Method: Preterm infants (gestational age less than 37 weeks) (n = 80) were recruited and randomly assigned using a random table format to either an incubator group (n = 40) or Kangaroo Mother Care group (n = 40). Pain assessments were carried out during four routine heel stick procedures. For the first heel stick, preterm infants in each group received no intervention (routinely stayed in incubator). During the next three heel sticks, the infants in Kangaroo Mother Care group received heel sticks during Kangaroo Mother Care, while infants in the incubator group received heel sticks in incubator. The procedure of each heel stick included 3 phases: baseline, blood collection and recovery. Crying, grimacing and heart rate in response to pain were evaluated at each phase across four heel sticks by three trained independent observers who were blinded to the purpose of the study. Data were analyzed by analysis of variance (ANOVA), with repeated measures at different evaluation phases of heel stick. Results: 75 preterm infants completed the protocol. Between-group comparison revealed that preterm infants’ heart rate was significantly lower, and the duration of crying and facial grimacing were both significantly shorter in the Kangaroo Mother Care group (n = 38) than the incubator group (n = 37) from the blood collection phase to recovery phase during repeated heel sticks. No significant within-group difference was found in heart rate between the baseline phase and recovery phase through repeated heel sticks for Kangaroo Mother Care group. In contrast, the incubator group experienced significant
Keywords: Crying Heart rate Kangaroo-Mother Care Method Pain Preterm infants
* Corresponding author at: School of Nursing, Nanjing University of Chinese Medicine, 138 Xianlin Road, Qixia District, Nanjing, Jiangsu Province 210023, China. Tel.: +86 25 85811639. E-mail address: [email protected] (G. Xu). http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006 0020-7489/ß 2015 Elsevier Ltd. All rights reserved.
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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within group differences in heart rate between baseline and recovery through repeated heel sticks. Conclusion: The effect of repeated Kangaroo Mother Care analgesia remains stable in preterm infants over repeated painful procedures. Given the many invasive procedures that are part of clinical care in preterm infants and most mothers preferred to provide comfort for their infants during painful procedures, Kangaroo Mother Care may be a safe analgesic alternative in preterm infants in whom it is feasible. ß 2015 Elsevier Ltd. All rights reserved.
What is already known about the topic? Hospitalization in neonatal intensive care units is required by the preterm infants; various diagnostic, surgical, or therapeutic procedures could be unpreventable and resulted in pain experiences. Exposure to repeated neonatal pain-related stress may lead to poorer cognitive, motor, and behavioral neurodevelopment in infants and children born very preterm. Kangaroo Mother Care, as one non-pharmacological method, has been established for the treatment of a single painful procedure, but the effectiveness of Kangaroo Mother Care across repeated painful procedures is unknown. What this paper adds The effect of repeated Kangaroo Mother Care analgesia remains stable in preterm infants over repeated painful procedures. Kangaroo Mother Care facilitated preterm infants’ behavioral and physical responses to return to the baseline phase more quickly than incubator care after repeated painful procedures. 1. Introduction The World Health Organization (WHO) reports that 15 million babies are prematurely born annually in the world (WHO, 2014). China contributes to 7.8% of these global preterm births, second only to India which is at the top of the list at 23.6% (Blencowe et al., 2012). Zhao and colleagues (2011) reported a 14% increase in preterm births from 2005 to 2009 in China; it is predicted more than 1.5 million preterm births will occur in China by 2015 (Zhao et al., 2012). Hospitalization in neonatal intensive care units (NICU) is required by preterm infants; however, various unpreventable therapeutic procedures could result in pain experiences for neonates (Evans et al., 2005; Lago et al., 2005). Neonatal rat models have demonstrated that persistent or repeated pain experiences increase apoptosis of neurons, and neonatal pain and stress lead to anxietylike behaviors during adulthood (Knaepen et al., 2013). Among preterm infants and children, repeated exposure to neonatal pain-related stress has been associated with altered brain microstructure and stress hormone levels, and poorer cognitive, motor, and behavioral neurodevelopment (Vinall and Grunau, 2014). Thus, pain management is a critical issue in current neonatal practice.
Preterm infants’ pain might not be effectively managed by opioids (Axelin et al., 2009; Carbajal et al., 2005), and pharmacological pain management may not be ideal due to medication side effects (Anand et al., 2004). Therefore, non-pharmacological pain management for preterm infants is essential in neonatal practice for pain management. One inexpensive and safe non-pharmacological strategy, which would also provide mothers an opportunity to comfort their infant during painful procedures in a technologically invasive environment, is Kangaroo Mother Care. Kangaroo Mother Care is operationally defined as the upright prone positioning of the diaper-clad infant, skinto-skin and chest-to-chest with an adult. The Kangaroo Mother Care method, which is aimed at offering human care to neonates, has been formally endorsed by the WHO (Department of Reproductive Health and Research, 2003). Many randomized controlled trials examining the management of pain during heel sticks and vaccinations have found Kangaroo Mother Care to have an analgesic effect on neonates (Akcan et al., 2009; Castral et al., 2008; Cong et al., 2009, 2011, 2012; Freire et al., 2008; Johnston et al., 2003, 2008, 2009; Kostandy et al., 2008; Ludington-Hoe et al., 2005; Nimbalkar et al., 2013; Okan et al., 2010; Saeidi et al., 2011). Furthermore, a recent systematic review concluded that skin to skin care appears to be effective and safe for a single painful procedure such as a heel stick (Johnston et al., 2014). However, there have been no studies examining the effectiveness of Kangaroo Mother Care across repeated painful procedures. Therefore, the purpose of this study was to determine if the analgesic effect changed with repeated Kangaroo Mother Care used in repeated painful events. We hypothesized that the effect of repeated Kangaroo Mother Care analgesia remains stable over repeated painful procedures. Behavioral and physiological outcomes are important to measure because they characterize preterm infants’ responses to pain. Young preterm infants often respond to pain differently in behavioral and physiologic measures (Cong et al., 2012; Sellam et al., 2011). Behavioral indicators for pain could include facial activity, cry, body movements and resting positions, fussiness/consolability, and sleeplessness. Crying is a common response to pain in infants (Gibbins and Stevens, 2001) and is considered to be a sensitive method for assessment of pain (Stevens et al., 2006). Some preterm and acutely ill infants may not cry during painful procedures, which may be due to depleted energy reserves, or an inability to cry because of the presence of an endotracheal tube (Johnston et al., 1999;
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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Ludington-Hoe et al., 2005). In the absence of crying (and with crying), the infant may exhibit ‘‘grimacing’’ (brow bulge, eye squeeze, and nasolabial furrowing). Grimacing has been reported in 99% of neonates exposed to heel sticks and is believed to be a very sensitive indicator of infant pain (Grunau and Craig, 1987; Grunau et al., 1990; Hadjistavropoulos et al., 1994). Physiological indicators for pain could include changes in heart rate, respiratory rate, oxygen saturation, and blood pressure. Heart rate (HR) is one of the most studied physiological pain indicators. For this study, we chose crying and grimacing as the behavioral indicators, and HR as the physiological indicator for neonatal pain.
2. Methods 2.1. Design This randomized controlled trial examined the effectiveness of 30-minute Kangaroo Mother Care on preterm infants’ behavioral and physiological responses to pain before and throughout three nonconsecutive routine heel sticks. Preterm infants were randomly assigned using a random table format to either an incubator group or Kangaroo Mother Care group. 2.2. Setting and sample Preterm infants were recruited from a level III NICU at a large teaching hospital in northeast China from May 2012 to October 2013. The inclusion criteria were infants: (1) singleton with gestational age less than 37 weeks, (2) cared for in an incubator, (3) anticipated to have at least four routine capillary blood draws within 2 weeks after birth, and (4) not scheduled to receive paralytic, analgesic, or sedative medications 48 h prior to a study session. Infants were excluded if they had any of the following conditions: congenital or neurological anomalies, grade III or IV intraventricular hemorrhage, surgery, signs of heel tissue breakdown or inflammation/necrosis, medically unstable, required oxygen or respiratory support, or mother had a history of drug abuse during pregnancy. In our pilot study, we found the average crying time during heel sticks for 15 preterm infants was 67.9 s (SD = 13.1). To detect a mean difference of 10 s in crying time during heel sticks between our two study groups, a power of 0.90, alpha of 0.05, and a 10% attrition rate was used to determine our estimated sample size of 80 preterm babies. 2.3. Conditions in incubator and Kangaroo Mother Care groups Condition in the incubator group: The infant, wearing only a diaper, was placed prone in the incubator at a 30– 408 incline to resemble the Kangaroo Mother Care position and remained undisturbed for 30 min before blood collection by heel stick, and then blood collection, and then the recovery phase were executed while the infant remained in the incubator in the same position. Mothers were not present during the incubator periods.
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Condition in the Kangaroo Mother Care group: Infants in the Kangaroo Mother Care group were given Kangaroo Care by their mothers in 30 min before, and throughout the recovery phase of the heel stick. With the guidance of a trained NICU nurse, the procedures of Kangaroo Mother Care are conducted by mothers as follows: Step 1: mother changed into a front-buttoning hospital gown and sat in her bed nearby the incubator, reclining at a 458angle. Step 2: the infant, naked except for his diapers, was transferred by the NICU nurse from the incubator to his mother’s breasts so that skin-to-skin contact was maintained through the open gown. Step 3: infant was covered with a blanket. Step 4: the mothers and infants were left for 30 min to allow them to rest comfortably in this skin-toskin contact position before blood collection by heel stick, and then blood collection, and then the recovery phase were executed in the Kangaroo Mother Care condition. After the procedure, the preterm infants were transferred back to an incubator or remained in the Kangaroo Mother Care condition if the mother preferred. 2.4. Measures 2.4.1. Measurement of behavioral pain indicator Behavioral pain indicators included: (1) duration of crying across the blood collection phase and recovery phase, and (2) duration of grimacing during the blood collection phase and recovery phase. The total duration of crying occurred respectively in blood collection phase and the recovery phase was monitored by using a digital audio recorder (MODEL F97) and calculated from all crying bouts, which were from the beginning of crying vocalization to the end of crying for 5 s or more (Ludington-Hoe et al., 2005). The total duration of grimacing was calculated in the same method as for crying by using video recording. Videotaping for the whole heel stick process, the research assistant (RA) coded it and downloaded it onto the personal computer, then one assessor who was unaware of the purpose of the study timed the duration of cry using the Lorus stopwatch to the nearest tenth of a second. At the blood collection phase of the first heel stick, all of the crying recordings (n = 80) were timed respectively by the assessor and the first author then crossexamined to ensure acceptable inter-rater agreement. The inter-rater reliability for the duration of crying between the evaluator and the first author was 98%. Intra-rater reliability was checked every 3 months, remaining more than 90%. Grimacing was defined as brow bulge, eye squeeze, and nasolabial furrowing occurring simultaneously and continuing 5 s or more, which was videotaped using a digital camera (Canon sx30is) by the RA. The camera was in closeup focus on the neonate’s face, with little surrounding area, no sound, and minimal color, and turned to an angle in the Kangaroo Mother Care condition as to mimic the prone position, in order to decrease the possibility of unblinding by the assessor who evaluated the grimacing response. The videotape of grimacing was coded and downloaded onto the personal computer by the RA, and then was evaluated by one trained assessor who could stop or restart the
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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videotape as many times as needed to establish the duration second by second. The methods we used to calculate the duration of grimacing in the blood collection phase and recovery phase, and the inter-rater agreement for grimacing between the first author and the assessor were respectively the same as for crying. The inter-rater reliability for the duration of grimacing at the blood collection phase of the first heel stick between the investigator and the evaluator was 97%. Intra-rater reliability for every assessment was checked every 3 months, remaining more than 90%.
two assessors evaluated infants’ crying and grimacing respectively (see Section 2.4.1). All personnel were trained separately by the first author. The first author, who knew the research purpose and protocol, was responsible for collecting infants’ demographic data and number of previously invasive procedures by reviewing medical records and nurses’ daily notes. Study fidelity was established by weekly meetings between the investigators and physician assistant.
2.4.2. Measurement of physiological indicator Physiological response to the painful stimulus was measured by the change in heart rate (HR) by using a continuously displaying in electrocardiogram monitor. The HR leads were attached to the infant’s chest, HR values were digitally sampled at 30-s interval by computer and were manually recorded by a nurse student. At the end of the study, the nurse student calculated the mean HR throughout baseline, blood collection and recovery phases of each heel stick procedure by personal computer through averaging the displaying data over 30 s.
SPSS version 19.0 software package was used in data analysis. Data were described using means and standard deviations for continuous variables and frequencies for categorical data. For comparisons among the three phases, measurement indicators (the duration of crying and grimacing, heart rate) across the subsequent three heel sticks were averaged separately. Variables were compared both within- and between-groups at different evaluation phases by using ANOVA, including one or two factors, both with repeated measures. If there was an interaction between conditions and evaluation phases, a simple main effect test was used. Tests of between or within-group post hoc simple effects were performed with Bonferroni corrections. The level of significance was set to 5% (p < 0.05) for all comparisons.
2.5. Procedures This study was approved by the institutional review board at the study site. One RA screened admission log every other day in the NICU, and finalized potential eligible infants, and explained and obtained oral consent from both parents. The procedure of each heel stick included three phases: (1) Baseline: one minute of baseline was collected at the end of the 30 min in the assigned condition, that is following 30 min of Kangaroo Mother Care or in incubator. (2) Blood collection: including antisepsis, heel stick, possible further squeezes and adhesive bandage applied to the site for hemostasis after blood was drawn, it lasted 1.5 min when (68 [90%] of 75) most procedures had been completed. (3) Recovery: 2 min following blood collection. For the first heel stick, each infant received with no intervention (routinely stayed in incubator), in order to observe the individual patterns of behavioral and physiological responses of the infants during the heel stick procedure. During the next three heel sticks, the infants in Kangaroo Mother Care group received heel sticks during Kangaroo Mother Care, while infants in the incubator group received heel sticks in incubator. Because the timing of blood sampling was determined by clinical needs, there were no fixed time points for data collection. Most heelstick events took place in the morning and the intervals of them ranged from 3 to 48 h. In order to coordinate the Kangaroo Mother Care procedure with mother’s visit, on the day before the infant was scheduled for blood draw by heel stick, one RA contacted mother to notify her of the session. The behavioral indicators (crying and grimacing) were collected by one RA and the physiological indicator data (heart rate) was collected by a nursing student. Heel stick procedures were performed by a physician assistant. The whole heel stick process was videotaped and coded, then
2.6. Data analysis
3. Results A total of 128 infants were screened, 97 met the criteria and were approached, and 80 agreed to participate. The reasons for refusal were: parents refused to videotape their infants due to their small size (n = 5), mothers did not want to do Kangaroo Mother Care (n = 5), mothers did not want the neonates to cry on her (n = 4), mother was too ill (n = 1), and the family lived too far to come in (n = 2). Only 75 had completed data, five infants dropped out because they were discharged prior to the required heel-sticks (see Fig. 1). The demographic data and the number of previously invasive procedures performed on preterm infants before the present study in incubator and Kangaroo Mother Care groups are presented in Table 1. There were no statistically significant differences in any of these above data between the two groups (p > 0.05). 3.1. Comparison of preterm infants’ behavioral and physical pain responses to the first heel stick (each group received no intervention) between incubator group and Kangaroo Mother Care group The ANOVA revealed that no significant interactions were found regarding the duration of crying (F = 0.821, p = 0.406), duration of grimacing (F = 0.525, p = 0.527) and heart rate (F = 0.683, p = 0.456) between conditions and evaluation phases. Moreover, there was no significant main effect between conditions for the three measured indicators (crying: F = 0.015, p = 0.904; grimacing: F = 1.662, p = 0.201; heart rate: F = 0.007, p = 0.936) (Table 2).
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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Assessed for eligibility (n=128)
Excluded (n =48) Meeting exclusion criteria (n =31) Refused to participate (n = 17)
n =80 Randomly allocated
Allocated to control (n=40)
Allocated to intervention (n = 40)
In the all four inconsecutive heel sticks,
In heel stick 1: infants received allocated
infants received allocated incubator condition
incubator condition exactly same as control
Heel stick 1 (n=40)
group; In heel stick 2, 3 and 4, infants
Heel stick 2 (n=39): 1 infant discharged prior
received allocated Kangaroo Mother Care
to second heel stick
condition.
Heel stick 3 (n=39)
Heel stick 1 (n=40)
Heel stick 4 (n=37): 2 infants discharged prior
Heel stick 2 (n=40)
to fourth heel stick
Heel stick 3 (n=39): 1 infant discharged prior to third heel stick Heel stick 4 (n=38): 1 infant discharged prior to fourth heel stick
Analyzed
Analyzed Repeated four heel sticks (n=37)
Repeated four heel sticks (n=38)
Fig. 1. Flow diagram of the recruitment and randomization process.
3.2. Comparison of preterm infants’ behavioral and physical pain responses to the repeated three heel sticks between incubator group and Kangaroo Mother Care group 3.2.1. Between-group differences in behavioral and physical pain responses during the repeated three heel sticks The ANOVA results showed significant interactions of the duration of crying (F = 48.955, p = 0.000, partial eta = 0.401) and grimacing (F = 28.858, p = 0.000, partial eta = 0.283) except heart rate (F = 1.858, p = 0.167) between conditions and evaluation phases. Between-group comparisons revealed that preterm infants’ heart rate was significantly lower, the duration of crying and facial grimacing were both significantly shorter in the Kangaroo
Mother Care group than the incubator group from the blood collection phase to recovery phase (Table 3). Moreover, there were more infants without crying (88%) or grimacing (86%) in the Kangaroo Mother Care group than in the incubator group (40% and 31% respectively) during the recovery phase. 3.2.2. Within-group differences in behavioral and physical pain responses during the repeated three heel sticks Crying, facial grimacing and heart rate showed similar patterns in incubator and Kangaroo Mother Care groups, namely increasing significantly followed by blood collection phase and decreasing afterwards. Within-group comparison revealed that there was significant difference
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Table 1 Comparisons of demographic data and number of previously invasive procedures between groups. Variable Gestational age, week 27–29a 30–34a >34a Gender Malea Femalea Method of delivery Vaginal deliverya Cesarean deliverya Birth weight, gb Gestational age at birth, weekb 5-minute Apgar scoreb Postnatal days Heel stick 1b Heel stick 2b Heel stick 3b Heel stick 4b Previous invasive proceduresb Duration of blood collection phase (s) Heel stick 1b Heel stick 2b Heel stick 3b Heel stick 4b
Incubator group
Kangaroo Mother Care group
p-Value
2 32 3
3 32 3
0.911
19 18
18 20
0.730
12 25 2030.0 135.6 33.3 1.6 7.2 1.5
15 23 2017.8 154.7 33.8 1.1 7.7 2.1
0.525 0.718 0.106 0.220
3.6 0.4 4.2 0.8 5.2 0.7 6.8 0.8 15.3 2.7
3.5 0.3 4.3 0.8 5.3 0.6 6.7 0.8 16.0 2.1
0.265 0.697 0.742 0.401 0.230
83.1 11.1 66.4 11.3 65.8 10.7 76.9 16.8
80.2 8.6 67.3 14.0 65.3 17.0 77.4 16.6
0.216 0.751 0.887 0.908
Note: a n. b Mean (standard deviation).
in the duration of both crying and grimacing between the baseline and recovery phases for the incubator group (p < 0.0001; p < 0.0001) and the Kangaroo Mother Care group separately (p = 0.008; p = 0.003) (Table 4). Significant differences were not found in heart rate between the baseline phase and recovery phase for the Kangaroo Mother Care group (p = 0.820). However, for the incubator group, heart rates remained significantly faster in the recovery phase compared to baseline phase (p = 0.004) (Table 4). In other words, in recovery phase, Kangaroo Mother Care group’s heart rate had returned to the baseline phase, while the incubator group’s heart rate had been still significantly faster than in the baseline phase. 4. Discussion Heel stick is a very common specimen collection method in NICU, and our study showed heel stick caused
pain evidenced by heart rate increased, crying and grimacing. There are substantial studies presenting short-term and long-term adverse neuro-developmental consequences of painful procedures (Hohmeister et al., 2009, 2010; Slater et al., 2010). The present study compared the impact of repeated Kangaroo Mother Care and incubator care on behavioral and physiological pain responses to repeated heel sticks in preterm infants. Regarding the heart rate, crying and grimacing responses, a significant difference in the three indicators was observed between the groups, with these indicators being smaller in the Kangaroo Mother Care group compared to the incubator group across the repeated heel sticks. The findings of efficacy of Kangaroo Mother Care in crying, grimacing and heart rate responses were in accordance with those of the previous studies conducting a single heel stick. Kostandy et al. demonstrated that preterm infants in Kangaroo Care 30 min had less crying
Table 2 Comparison of pain responses to the first heel stick (each group with no intervention). Baselinea Crying (s) Incubator group Kangaroo Mother Care group Grimacing (s) Incubator group Kangaroo Mother Care group HR (beats/min) Incubator group Kangaroo Mother Care group
Blood collectiona
Recoverya
0 0
63.5 9.0 65.7 6.6
16.8 16.5 15.2 15.5
0 0
78.1 8.1 75.0 7.9
18.9 16.7 16.5 15.9
165.4 11.8 167.1 10.2
160.9 10.1 160.9 9.3
149.3 13.3 147.2 16.2
Note: Data are listed as mean SD. HR: heart rate. a Mean (standard deviation).
Please cite this article in press as: Gao, H., et al., Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int. J. Nurs. Stud. (2015), http://dx.doi.org/10.1016/j.ijnurstu.2015.04.006
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Table 3 Between-group comparison of pain responses to the repeated three heel sticks. Baselinea Crying (s) Incubator group Kangaroo Mother Care group Between-groups Pb Grimacing (s) Incubator group Kangaroo Mother Care group Between-groups Pb HR (beats/min) Incubator group Kangaroo Mother Care group Between-groups Pb
Blood collectiona
Recoverya
0 0 –
60.4 8.9 34.3 16.6 p < 0.0001c
12.7 10.9 0.9 1.7 p < 0.0001c
0 0 –
62.3 8.9 40.3 18.9 p < 0.0001c
14.8 11.1 1.1 1.9 p < 0.0001c
162.0 10.5 154.4 10.2 0.002c
152.8 8.4 144.9 9.5 p < 0.0001c
146.4 11.8 143.1 10.0 0.194
Note: Data are listed as mean SD. HR: heart rate. a Mean (standard deviation). b Bonferroni correction for multiples comparisons. c p < 0.05
infants, Kangaroo Mother Care infants’ mean duration of crying and grimacing in the recovery phase were near to baseline phase durations, although statistical significances were both found between the baseline phase and the recovery phase. Moreover, most infants in the Kangaroo Mother Care group had no crying (88%) or grimacing (86%) during the recovery phase. In addition, infants’ HR in the Kangaroo Mother Care group at the recovery phase had returned to the baseline phase. The results of this study indicate that Kangaroo Mother Care can facilitate not only a diminished response, but also a quicker recovery in infants, which was consistent with the previous reports (Castral et al., 2008; Johnston et al., 2008, 2011; Shah and Jefferies, 2012). The ability to recover quickly is a sign of ability to maintain homeostasis, a major task that the very preterm neonate must accomplish in order to grow and develop (Moore and Anderson, 2007). The strengths included in the present study are: (1) We have controlled for contextual factors associated with pain response of preterm infants in different study groups. Factors such as past painful procedures, gender, mechanical ventilation, APGAR scores, gestational age, birth weight, postnatal days may all affect response to pain. The two groups did not differ in terms of the above data indicating
time during the heel stick and recovery phases (Kostandy et al., 2008). Ludington-Hoe et al. reported that heart rate and crying responses to pain were significantly reduced in preterm newborns given 3 h of Kangaroo Care before a heel stick (Ludington-Hoe et al., 2005). In a study conducted on 95 preterm neonates, Freire et al. observed a reduction in heart rate variation and duration of facial actions across 30 s after the heel-lancing procedure in infants held in Kangaroo Care (Freire et al., 2008). The result from Okan et al. study showed that heart rate, oxygen saturation changes, length of crying and grimacing were significantly reduced in healthy term neonates with skin-to-skin contact undergoing heel-lance than infants who were lying on the table (Okan et al., 2010). A study comparing pain responses of preterm neonates who were receiving 15-minute Kangaroo Mother Care with infants who were receiving routinely incubator care during heel stick found that Kangaroo Mother Care statistically decreased infants’ heart rate, behavior and facial scores (Nimbalkar et al., 2013). Perhaps more importantly, was the significantly reduced time to recovery. Of clinical interest on procedural pain in preterm infants are response, that is the degree to which they respond; and recovery, how quickly they return to baseline state. Compared to incubator group
Table 4 Within-group comparison of pain responses to the repeated three heel sticks. Baselinea Crying (s) Incubator group Kangaroo Mother Care group Grimacing (s) Incubator group Kangaroo Mother Care group HR (beats/min) Incubator group Kangaroo Mother Care group
Blood collectiona
Recoverya
p (one-way RM ANOVA)
0b,c 0b,d
60.4 8.9 34.3 16.6
12.7 10.9 0.9 1.7
p < 0.0001 p < 0.0001
0b,c 0b,d
62.3 8.9 40.3 18.9
14.8 11.1 1.1 1.9
p < 0.0001 p < 0.0001
146.4 11.8b,c 143.1 10.0b,e
162.0 10.5 154.4 10.2
152.8 8.4 144.9 9.5
p < 0.0001 p < 0.0001
Note: Data are listed as mean SD. HR: heart rate. a Mean (standard deviation). b Bonferroni correction for multiples comparisons. c Significant difference when compared with recovery–incubator group (p < 0.05). d Significant difference when compared with recovery–Kangaroo Mother Care group (p < 0.05). e No significant difference when compared with recovery–Kangaroo Mother Care group (p > 0.05).
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uniformity of the sample analyzed. In addition, severity of illness can affect the infant’s ability to mount a response to pain. Severity of illness was not measured in this study, however all eligible infants were medically stable, not requiring oxygen or respiratory support, according to the protocols of the units at the time the study began. (2) The strategies undertaken to enhance the internal validity of these results. The use of 1 person conducting all heel sticks, the work of videotaping and evaluating of behavioral response are performed by different people. (3) Physiological response was measured every 30 s and collected accurately by computer. (4) In order to arrive at a better understanding of the data obtained, the preterm infants’ pain response patterns were established prior to interventions. Despite its strengths, this study had some limitations as follows: (1) The behavioral state of the infants before heel stick was not collected in the present study. Thus, we were unable to determine if the baby was in a homeostatic state at baseline, which may have influenced the pain responses, especially heart rate. (2) The grimacing evaluating procedure could not be completely blind to Kangaroo Mother Care conditions because maternal respiratory movements may move the infant’s face up and down in the video, as reported by other researchers (Johnston et al., 2008; Ludington-Hoe et al., 2005). (3) It was impossible to blind the physician assistant conducting the heel stick procedure, so that he may have been gentler during Kangaroo Mother Care condition, which was previously reported by Johnston et al. (2008). (4) Most infants eligible for the study were of a gestational age 33–34 weeks, which did not allow for appropriate analysis by gestational age due to subgroups being too small. Future studies could measure the infant’s behavioral state before painful procedures, in order to avoid its possible confounding effect on pain response. Infants in this study were all medically stable, future studies could examine the effect of repeated Kangaroo Mother Care on repeated procedural pain for medically unstable infants. Furthermore, the present study focused on the behavioral and physiological changes caused by heel sticks in order to provide a detailed analysis over the entire sampling period. Future research could use a composite pain tool such as Premature Infant Pain Profile (PIPP) or N-PASS to examine the effectiveness of Kangaroo Mother Care on the overall changes in the summary scores. In addition, the comparison of pain-relief effects between Kangaroo Mother Care and other non-pharmacological interventions can be examined during repeated painful procedures. Further research needs to compare whether there is difference in the effectiveness of repeated use of Kangaroo Mother Care between infants with different gestational ages. 5. Conclusions The results of this randomized controlled trial provide evidence that a 30-minute Kangaroo Mother Care remains effective in reducing heel-stick pain across at least three heel stick procedures. Given most mothers agreed to perform Kangaroo Mother Care in the study and the number of invasive procedures, especially heel-stick
procedure, is high, based on the results of the present study, it appears reasonable to offer the option of kangaroo care to mothers who want to provide comfort to their stable preterm infant during repeated painful procedures. It is therefore important for neonatal staff to contact mothers and notify them in advance that the infant is scheduled for blood draws and other painful procedures. When it is impossible to have mothers present for each painful procedure, the neonatal staff may apply other alternative non-pharmacological methods such as sucrose to preterm infants. Acknowledgments We appreciated very much to all of the participants and their parents in this study. The Preponderant Discipline Project of Universities in Jiangsu Province for grant support (YSHL0503-01). Finally, we gratefully acknowledged Professor S.Y. Lee and Jiayun Xu for their writing assistance. Conflict of interest. None declared. Funding. Funded by the Preponderant Discipline Project of Universities in Jiangsu Province, Nursing Science Open Fund of Nanjing University of Chinese Medicine (YSHL0503-01). Ethical approval. Human subjects approval was obtained from Binzhou Medical University Hospital, Binzhou, China. References Akcan, E., Yig˘it, R., Atici, A., 2009. The effect of kangaroo care on pain in premature infants during invasive procedures. Turk. J. Pediatr. 51 (1), 14–18. Anand, K.J., Hall, R.W., Desai, N., Shephard, B., Bergqvist, L.L., Young, T.E., Boyle, E.M., Carbajal, R., Bhutani, V.K., Moore, M.B., Kronsberg, S.S., Barton, B.A., NEOPAIN Trial Investigators Group, 2004. Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial. Lancet 363 (9422), 1673– 1682. Axelin, A., Salantera¨, S., Kirjavainen, J., Lehtonen, L., 2009. Oral glucose and parental holding preferable to opioid in pain management in preterm infants. Clin. J. Pain 25 (2), 138–145. Blencowe, H., Cousens, S., Oestergaard, M.Z., Chou, D., Moller, A.B., Narwal, R., Adler, A., Vera Garcia, C., Rohde, S., Say, L., Lawn, J.E., 2012. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet 379 (9832), 2162–2172. Carbajal, R., Lenclen, R., Jugie, M., Paupe, A., Barton, B.A., Anand, K.J., 2005. Morphine does not provide adequate analgesia for acute procedural pain among preterm neonates. Pediatrics 115 (6), 1494–1500. Castral, T.C., Warnock, F., Leite, A.M., Haas, V.J., Scochi, C.G., 2008. The effects of skin-to-skin contact during acute pain in preterm newborns. Eur. J. Pain 12 (4), 464–471. Cong, X., Cusson, R.M., Walsh, S., Hussain, N., Ludington-Hoe, S.M., Zhang, D., 2012. Effects of skin-to-skin contact on autonomic pain responses in preterm infants. J. Pain 13 (7), 636–645. Cong, X., Ludington-Hoe, S.M., McCain, G., Fu, P., 2009. Kangaroo care modifies preterm infant heart rate variability in response to heel stick pain: pilot study. Early Hum. Dev. 85 (9), 561–567. Cong, X., Ludington-Hoe, S.M., Walsh, S., 2011. Randomized crossover trial of kangaroo care to reduce biobehavioral pain responses in preterm infants: a pilot study. Biol. Res. Nurs. 13 (2), 204–216. Department of Reproductive Health and Research, 2003. Kangaroo Mother Care: A Practical Guide, 1st ed. World Health Organization, Geneva. Evans, J.C., McCartney, E.M., Lawhon, G., Galloway, J., 2005. Longitudinal comparison of preterm pain responses to repeated heelsticks. Pediatr. Nurs. 31 (3), 216–221. Freire, N.B., Garcia, J.B., Lamy, Z.C., 2008. Evaluation of analgesic effect of skin-to-skin contact compared to oral glucose in preterm neonates. Pain 139 (1), 28–33.
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