Article
The effects of three different distraction methods on pain and anxiety in children
Journal of Child Health Care 1–9 ª The Author(s) 2015 Reprints and permission: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1367493515587062 chc.sagepub.com
Nejla Canbulat Sahiner1 and Meltem Demirgoz Bal2
Abstract This study aims to investigate of three different distraction methods (distraction cards, listening to the music of cartoon and balloon inflation) on pain and anxiety relief of children during phlebotomy. This study is a prospective, randomized, and controlled trial. The sample consisted of 6 to 12 years old children who require blood tests. Children were randomized into four groups as the distraction cards, the music, the balloon inflation, and the control. Data were obtained by conducting interviews with the children, their parents, and the observer before and after the procedure. The pain levels of the children were assessed by the parent and observer reports as well as self-report using the Wong-Baker FACES. The anxiety levels of children were assessed by parent and observer reports using Children Fear Scale. One hundred and twenty children (mean age: 9.1 + 1.6 years) were included. The self-reported procedural pain levels showed significant differences among the study groups (p ¼ .040). The distraction card group (2.33 + 3.24) had significantly lower pain levels (p ¼ .057) than the control group (4.53 + 3.23). The procedural child anxiety levels reported by the observer showed a significant difference among the study groups (p ¼ .032). All the forms of distraction significantly reduced pain and anxiety perception. Keywords Acute care, evidence-based practice, pain
Introduction Pain among children and adolescents has been identified as an important public health problem (Roth-Isigkeit et al., 2005). Medical procedures that are applied using a needle, such as 1
Department of Pediatric Nursing, School of Health, Karamanoglu Mehmetbey University, Karaman, Turkey Department of Obstetric and Gynecologic Nursing, School of Health, Karamanoglu Mehmetbey University, Karaman, Turkey 2
Corresponding author: Nejla Canbulat Sahiner, Department of Pediatric Nursing, School of Health, Karamanoglu Mehmetbey University, Karaman 70100, Turkey. Email: [email protected]
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venipuncture and immunization, are the most common and important sources of pain for children, causing anxiety, distress, and fear (Blount et al., 2009; Leahy et al., 2008; Uman et al., 2006). If a child’s pain is not treated quickly and effectively, it can cause long-term physical and psychological sequelae. Therefore, it is important for all health-care providers to understand the importance of effective pain control in children (Wong at al., 2012). Pain management includes pharmacological and non-pharmacological approaches (Taddio et al., 2010). Non-pharmacological approaches include distraction activities such as singing, reading, or playing a game (Cohen et al., 2006; Schechter et al., 2007). The benefits of using non-pharmacological methods include decreased pain, distress, and anxiety reported by the parent, child, and/or observer (Wente, 2013). Distraction is a simple and effective technique that directs children’s attention away from noxious stimuli. However, there are a multitude of techniques and technologies associated with distraction (Koller and Goldman, 2012). Recently, it has been shown that using distraction cards is also a beneficial method for dealing with pain during phlebotomy (Canbulat et al., 2014; Inal et al., 2012). Nurses have also been using music to reduce pain for a long time (Balan et al., 2009; Caprilli et al., 2007; Klassen et al., 2008; Kristjansdottir and Kristjansdottir, 2011; Press et al., 2003). It has been shown that distraction with music may have a positive impact on pain and distress for children undergoing intravenous placement (Hartling et al., 2013). Music is inexpensive, easily administered, and free of adverse effects and, as such, can serve as a complementary method for treating perioperative stress and for acute and chronic pain management (Matsota et al., 2013). Additionally, it has been shown that distracting a child by inflating a balloon is also a beneficial method for dealing with pain during phlebotomy (Gupta et al., 2006; Manne et al., 1990). This aim of this study was to compare the effect of distraction by applying distraction cards (Flippits1), listening to the music of a cartoon, and balloon inflation to reduce procedural pain and anxiety during phlebotomy in children between the ages of 6 and 12.
Methods Study design This study was conducted at the Phlebotomy Unit of the Karaman Maternity and Children Hospital. It was designed as a prospective randomized clinical trial that evaluated and compared the effects of distraction cards, listening to cartoon music, and balloon inflation on pain and anxiety levels in children during phlebotomy.
Setting and samples The study population consisted of children aged 6–12 years who requested blood tests. The study sample size was determined by power analysis and was based on previous research (Canbulat et al., 2014; Inal and Kelleci, 2012), with a 1.5-point SD for the experimental group and 2.0 for the control group. With a power of 0.8 and an acceptable type I a error size of .05, each group required 30 individuals. Children were randomized into four groups: the distraction card group, listening to cartoon music group, the balloon inflation group, and the control group. All data were obtained by interviewing the children, their parents, and the observer after the procedure. The phlebotomy process took an average of three minutes (minimum 1 minute and maximum 5 minutes). The current application of this study is that nurses, in the hospitals where we conducted the study, are now using pain relief methods during phlebotomy. Routinely, hospitals in Turkey do not use pharmacological and non-pharmacological methods to reduce pain and anxiety during
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phlebotomy. Parents are allowed but not required to stay with children during phlebotomy. In this study, all parents stay with their children during phlebotomy.
Ethical considerations The study was approved by the ethics committee of Selcuk University, Selcuklu Medical Faculty (2014/21), Konya, Turkey. The aim and method of the study were explained to the children and their parents, and they were informed that if they did not want to continue, they could withdraw from the study without stating a reason.
Measurement/instruments Distraction cards. The distraction cards (Flippits1, MMJ Labs, Atlanta, Georgia, USA) consisted of visual cards of 5 8 cm2, covered with various pictures and shapes. In this method, the children carefully examined the cards, then the researcher asked some questions about those cards to be answered by the children, such as ‘How many ladybugs are there in the picture?’ and ‘How many apes are there in the picture?’ or ‘Can you see the comet?’ The distraction procedure via distraction cards began just before the phlebotomy and continued until the procedure was complete. Because the children’s native language is not English, the translation of the instrument was conducted by an expert who knows both languages. Music playback. The music played during the study was the music of cartoons that are watched mostly by children aged 6–12 years. Fifteen cartoons in total were used in the room where blood was taken, and the kids were asked to which cartoon the music belonged. It was skipped to another song when the kids recognized the music. This process continued while blood was taken. Balloon inflation. The kids were given whatever color balloons they wanted. They were asked to inflate the balloon before process and kept on inflating after the process was concluded, at which time the kids were given the balloons they inflated. Control group. The kids in this group were allowed to keep their family near. The routine bloodtaking procedure was applied. The level of pain resulting from the applied procedure in each child was assessed by the selfreports as well as the parent and observer reports, using the Wong-Baker FACES (WB-FACES) pain rating scale. The WB-FACES scale is a 0 to 10 scale, showing six cartoon faces that range from a neutral expression (0 ¼ very happy/no hurt) to a crying face (10 ¼ hurts as much as you can imagine). Children Fear Scale (CFS) was used to evaluate the children’s level of anxiety. CFS is a 0 to 4 scale, showing five cartoon faces that range from a neutral expression (0 ¼ no anxiety) to a frightened face (4 ¼ severe anxiety). Pre-procedural and procedural pain, as well as anxiety, for all children was evaluated using CFS by both parents and the researchers.
Data collection/procedure This study was conducted with two volunteer nurses trained by the researcher. The nurses had a minimum of five years of experience in pediatric patient care and venipuncture. The nurses did not
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have any conflict of interest. Before the procedure, a pediatrician made clinical decision for phlebotomy. For patients agreeing to participate, background demographic information, medical history, recent analgesics, and body mass index (BMI) were collected via self-report forms. Prior to randomization, the researcher read a standard script to explain the pain and anxiety measures. Both parents and children indicated that they understood how to use the measures. The first nurse, the ‘observer nurse’, evaluated the pre-procedural and procedural anxiety and procedural pain for all children using the 0–4 CFS for anxiety and the 0–10 WB-FACES scale for pain. The second nurse conducted the phlebotomy procedure for all children. The parents and observers assessed the children’s anxiety levels. One hundred and twenty children were randomized on the basis of a computer-generated table of random numbers into three equal groups. After the assignment, children and their parents moved into the phlebotomy unit for the procedure. Venipunctures were performed between 08:00–12:00 hours and 12:00–16:00 hours with a vacutainer and a 21 G needle. The same nurse conducted all distraction methods for all children. All parents stayed with their children during the procedure. The procedure was considered successful if blood started running into the tube in 15 seconds. If the blood specimen collection could not be done in the first attempt, the procedure was attempted in the distal part of the same arm. When second attempts were needed, the distraction methods continued from the beginning of the first attempt until the end of the last attempt. After the procedure, the children’s pain levels were assessed by self-report and by parents’ and the observer’s report.
Data analysis All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS Inc., Chicago, Illinois, USA) version 21.0 for Windows. Baseline characteristics among the groups, and all parametric data were analyzed by employing the 2 test and Student’s t-test. Statistical significance was set at p < .05. Parametric data such as the level of pain in children was compared with one-way analysis of variance. If the p value was significant (p < .05), a Bonferroni test was performed as a post hoc analysis.
Results Comparison of the groups in terms of some variables One hundred and twenty children (57 (47.5%) female and 63 (52.5%) male) were included in the present study. The mean age of the children was 9.1 + 1.6 years (range: 6–12 years). The children were randomized into the listening to music (n ¼ 30), the distraction cards (n ¼ 30), the balloon inflation (n ¼ 30), and the control (n ¼ 30) groups. Table 1 presents the characteristics of the children. Age, gender, BMI, pre-procedural anxiety levels of children, and success of phlebotomy attempts were similar among the four groups. There were no significant differences among pre-procedural anxiety levels of the study groups in terms of self, parent, and observer reports (p ¼ .099, p ¼ .300, and p ¼ .811, respectively).
Comparison of the groups in terms of pain levels The evaluation of procedural pain levels during phlebotomy collection is presented in Table 2. The self-reported procedural pain levels showed significant differences among the study groups (p ¼ .040). The distraction card group (2.33 + 3.24) had significantly lower pain levels (p ¼ .057)
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Table 1. Baseline characteristics and pre-procedural anxiety scores of the study groups. Distraction card group (n ¼ 30) Gender Female 15 (50) Male 15 (50) BMI 29.03 + 7.6 Pre-procedural anxiety levels Self-reported 1.67 + 1.47 Parent-reported 1.23 + 1.27 Observer-reported 1.53 + 1.52 Success of phlebotomy attempt In first attempt 27 (90) In second attempt 3 (10)
Balloon inflation group (n ¼ 30)
Listening music of cartoon group (n ¼ 30)
Control group (n ¼ 30)
12 (40) 18 (60) 25.97 + 8.05
16 (53.3) 14 (46.7) 25.23 + 8.87
14 (46.7) 16 (53.3) 29.70 + 10.3
0.935
2.60 + 2.14 1.37 + 1.27 1.10 + 2.85
1.70 + 1.41 1.83 + 1.31 1.40 + 1.35
2.10 + 1.37 1.33 + 1.39 1.50 + 1.50
0.099 0.300 0.811
25 (83.3) 5 (16.7)
29 (96.7) 1 (3.3)
0.509
27 (90) 3 (10)
p Value
0.132
BMI: body mass index. Note: Data are represented as number (percentage) or mean + standard deviation, where appropriate.
than the control group (4.53 + 3.23). There were also no significant differences in both the parentand observer-reported procedural pain levels among the study groups (p > .05 for each), and all the distraction groups’ (distraction card, listening to cartoon music, and balloon inflation) pain levels were lower than the control group (p ¼ .057, p ¼ .108, p ¼ .410, respectively). The parent-reported pain levels in the distraction card group were also significantly lower than that of the control group (p ¼ .055).
Comparison of the groups in terms of anxiety levels The procedural anxiety levels during phlebotomy are presented in Table 3. The procedural child anxiety levels reported by the observer showed a significant difference among the study groups (p ¼ .032). The anxiety levels in the balloon inflation group were significantly lower than the other groups (distraction card, listening to cartoon music, and control; p ¼ .049), whereas the scores in the distraction card and listening to cartoon music groups were also lower than the control group.
Discussion Pain experienced during the medical procedures that are routinely performed in hospitals, such as phlebotomy and immunization, may cause stress, fear, and anxiety in children (Cassidy et al., 2001; Razzaq, 2006). The American Society for Pain Management Nursing recommends that optimal pain control before and during painful procedures needs to be provided. Therefore, pharmacological and non-pharmacological approaches should be used to control acquired pain and the resulting future anxiety. Currently, a number of interventions are used to reduce pain perception during medical procedures, and distraction is one of the most commonly used and effective ones (Schechter et al., 2007). Distraction methods are widely used to reduce procedural pain and anxiety (Canbulat et al., 2014; He et al., 2005; Inal and Kelleci, 2012; Tu¨fekci et al., 2009). The methods are performed in various ways during medical procedures to divert the patient’s attention (Arts et al., 1994; Cassidy
6 3.87 + 3.631 3.13 + 2.76 4.13 + 3.40
4.53 + 3.23 3.53 + 2.95 4.07 + 2.90 0.040 0.055 0.062
0.057*
p Value
0.108*
0.410*
1.000*
0.77 + 1.27 0.40 + 0.77
Note: Data are represented as mean + standard deviation. *Bonferroni test results.
Parent-reported 0.80 + 1.21 Observer-reported 0.83 + 1.23
0.90 + 1.29 1.17 + 1.28
1.27 + 1.41 1.23 + 1.40
0.429 0.032
0.987*
0.049*
0.89*
1.000*
Listening music Balloon Listening music Distraction Balloon Distraction card group inflation group of cartoon group Control group card group inflation group of cartoon group Control group (n ¼ 30) (n ¼ 30) (n ¼ 30) (n ¼ 30) (n ¼ 30) p Value (n ¼ 30) (n ¼ 30) (n ¼ 30)
Table 3. Comparison of procedural anxiety scores of the study groups.
WB-FACES: Wong-Baker FACES. Note: Data are represented as mean + standard deviation. *Bonferroni test results.
Procedural anxiety scores
p Value
Listening music Balloon Listening music Distraction Balloon Distraction card group inflation group of cartoon group Control group card group inflation group of cartoon group Control group (n ¼ 30) (n ¼ 30) (n ¼ 30) (n ¼ 30) (n ¼ 30) p Value (n ¼ 30) (n ¼ 30) (n ¼ 30)
According to WB-FACES Self-reported 2.33 + 3.24 4.33 + 23.11 Parent-reported 1.87 + 2.96 2.513 + 1.96 Observer-reported 2.20 + 3.21 2.60 + 4.14
Procedural pain scores
Table 2. Comparison of procedural pain scores of the study groups.
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et al., 2002; Mason et al., 1999; Tu¨fekci et al., 2009). Recently, Inal and Kelleci (2012) and Canbulat et al. (2014) demonstrated that distraction cards (Flippits) were very effective in reducing procedural pain and anxiety in children during phlebotomy. In this study, in parallel to the literature of distraction during blood collection, the distraction card group had lower pain scores compared to other groups (listening to cartoon music and balloon group); additionally, self-reported and parentreported pain according to the difference was found to be statistically significant. Several studies have reported that for many patients music reduced anxiety and aggressive behavior (Balan et al., 2009; Caprill et al., 2007; Klassen et al., 2008; Kristjansdottir and Kristjansdottir, 2011; Press et al., 2003). Press et al. (2003) examined the effect of music in reducing pain during blood collection from children aged 6 to 16 years in the emergency department and found no significant differences compared with the control group. It was compared the efficacy of a local anesthetic cream with music distraction in reducing or preventing pain from needle puncture (intravenous cannulation) in children (Arts et al., 1994). The results showed that lidocaine–prilocaine emulsion was highly effective in preventing pain from venipunctures in young children. Balan et al. (2009) compared the comparative efficacy of local anesthetic cream, Indian classical instrumental music, and placebo in reducing pain due to venipuncture in children. The results showed that pain experienced during venipuncture was significantly reduced using EMLA or Indian classical instrumental music. Caprill and colleagues (2007) aimed to determine whether the presence of musicians, who had attended specific training to work in medical settings, could reduce distress and pain in children who were giving blood samples. Their results demonstrated that songs and music performed by professional musicians had a beneficial effect in reducing distress before, during, and after blood sampling. Kristjansdottir and Kristjansdottir (2011) conducted a study on 128 adolescents during inactivated polio vaccination in randomized, controlled trials. The adolescents were divided into three groups: musical distraction with headphones, musical distraction without headphones, and standard care control. After testing for covariates, their results showed that the adolescents who received musical distraction were less likely to report pain compared with the control group. When the musical distraction techniques were compared, the elimination of headphones emerged as a significant predictor of no pain, which suggests that an easy and practical musical distraction intervention, implemented without headphones, can give some pain relief. In the present study, consistent with the previously reported musical distraction groups, the group who listened to the cartoon soundtrack music had lower pain and anxiety scores compared with the control group; however, there was no statistically significant difference between the distraction group and the control group. One of the frequently used methods of pain and anxiety reduction is balloon inflation. Manne et al. (1990) reported that it was an effective method in reducing the family’s and the child’s stress. French et al. (1994) and Blount et al. (1992) reported that a simple distraction technique (party blower and deep breathing) can be effective in helping children cope with the pain of immunization. Gupta et al. (2006) showed that children’s pain levels were significantly lower in the balloon inflation group than in the control group. As in this study, other research groups have found that balloon inflation significantly lowered procedural anxiety scores, thus providing an effective technique during painful medical procedures. It is widely accepted that most children who previously experienced a painful medical procedure are fearful and anxious about future procedures. Therefore, decreasing the emotional effects of painful procedures in clinical practice with better pain control is important for children. In order to avoid the future undesirable effects of painful medical procedures, a successful pain control technique should be implemented.
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Conclusion All the forms of distraction (distraction cards, listening to cartoon music, and balloon inflation) significantly reduced pain and anxiety perception. Nurses need to be aware of procedural anxiety and pain during phlebotomy. Distraction methods should be implemented to decrease anxiety and pain in children. This study contributes to the literature on non-pharmacological pain relief methods and should be replicated in more settings to see whether the findings are similar. Acknowledgments We are also grateful to the subjects of this study for agreeing to participate in this study. Authors’ Note Authors NCS and MDB contributed to the study design, data collection, and manuscript preparation and NCS helped in data analysis. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. References Arts SE, Abu-Saad HH, Champion GD, et al. (1994) Age-related response to lidocaine-prilocaine (EMLA) emulsion and effect of music distraction on the pain of intravenous cannulation. Pediatrics 93(5): 797–801. Balan R, Bavdekar SB and Jadhav S (2009) Can Indian classical instrumental music reduce pain felt during venepuncture? Indian Journal of Pediatrics 76: 469–473. Blount RL, Bachanas PJ, Powers SW, et al. (1992) Training children to cope and parents to coach them during routine immunizations: effects on child, parent, and staff behaviors. Behavior Therapy 23(4): 689–705. Blount RL, Zempsky WT, Jaaniste T, et al. (2009) Management of pain and distress due to medical procedures. In: Roberts MC and Steele R (eds) Handbook of Pediatric Psychology. 4th ed. New York: Guilford Press, pp. 171–188. _ S and Sonmezer H (2014) Efficacy of distraction methods on procedural pain and anxiety by Canbulat N, Inal applying distraction cards and kaleidoscope in children. Asian Nursing Research 8: 23–28. Caprilli S, Anastasi F, Grotto RP, et al. (2007) Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. Journal of Developmental and Behavioral Pediatrics 28: 399–403. Cassidy KL, Reid GJ, McGrath PJ, et al. (2001) A randomized double-blind, placebo-controlled trial of the EMLA patch for the reduction of pain associated with intramuscular injection in four to six-year-old children. Acta Paediatrica 90(11): 1329–1336. Cassidy KL, Reid GJ, McGrath PJ, et al. (2002) Watch needle, watch TV: audiovisual distraction in preschool immunization. Pain Medicine 3(2): 108–118. Cohen LL, Bernard RS, McClellan CB, et al. (2006) Topical anesthesia versus distraction for infants’ immunization distress: evaluation with 6-month follow-up. Children’s Health Care 35(2): 103–121. French GM, Painter EC and Coury DL (1994) Blowing away shot pain: a technique for pain management during immunization. Pediatrics 93(3): 384–388.
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Gupta D, Agarwal A, Dhiraaj S, et al. (2006) An evaluation of efficacy of balloon inflation on venous cannulation pain in children: a prospective, randomized, controlled study. Anesthesia & Analgesia 102(5): 1372–1375. Hartling L, Newton AS, Liang Y, et al. (2013) Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. Journal of the American Medical Association pediatrics 167(9): 826–35. He HG, Po¨lkki T, Vehvila¨inen-Julkunen K, et al. (2005) Chinese nurses’ use of non-pharmacological methods in children’s postoperative pain relief. Journal of Advanced Nursing 51(4): 335–342. Inal S and Kelleci M (2012) Distracting children during blood draw: looking through distraction cards is effective in pain relief of children during blood draw. International Journal of Nursing Practice 18(2): 210–219. Klassen JA, Liang Y, Tjosvold L, et al. (2008) Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambulatory Pediatrics 8: 117–128. Koller D and Goldman RD (2012) Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs 27(6): 652–681. Kristjansdottir O and Kristjansdottir G (2011) Randomized clinical trial of musical distraction with and without headphones for adolescents’ immunization pain. Scandinavian Journal of Caring Sciences 25: 19–26. Leahy S, Kennedy RM, Hesselgrave J, et al. (2008) On the front lines: lessons learned in implementing multidisciplinary peripheral venous access pain-management programs pediatric hospitals. Pediatrics 122(Suppl 3): 161–170. Manne SL, Redd WH, Jacobsen PB, et al. (1990) Behavioral intervention to reduce child and parent distress during venipuncture. Journal of Consulting and Clinical Psychology 58: 565–572. Mason S, Johnson MH and Woolley C (1999) A comparison of distractors for controlling distress in young children during medical procedures. Journal of Clinical Psychology in Medical Settings 6: 239–248. Matsota P, Christodoulopoulou T, Smyrnioti ME, et al. (2013) Music’s use for anesthesia and analgesia. Journal of Alternative and Complementary Medicine 19(4): 298–307. Press J, Gidron Y, Maimon M, et al. (2003) Effects of active distraction on pain of children undergoing venipuncture: who benefits from it? The Pain Clinic 15: 261–269. Razzaq Q (2006) The underuse of analgesia and sedation in pediatric emergency medicine. Annals of Saudi Medicine 26(5): 375–381. Roth-Isigkeit A, Thyen U, Sto¨ven H, et al. (2005) Pain among children and adolescents: restrictions in daily living and triggering factors. Pediatrics 115(2): e152–e162. Schechter NL, Zempsky WT, Cohen LL, et al. (2007) Pain reduction during pediatric immunizations: evidence-based review and recommendations. Pediatrics 119: 1184–1198. Taddio A, Appleton M, Bortolussi R, et al. (2010) Reducing the pain of childhood vaccination: an evidencebased clinical practice guideline. Canadian Medical Association Journal 182: 43–55. Tu¨fekci FG, Celebiog˘lu A and Ku¨c¸u¨kog˘lu S (2009) Turkish children loved distraction: using kaleidoscope to reduce perceived pain during venipuncture. Journal of Clinical Nursing 18(15): 2180–2186. Uman LS, Chambers CT, McGrath PJ, et al. (2006) Psychological interventions for needle-related procedural pain and distress in children and adolescents. Evidence-Based Child Health: A Cochrane Review Journal 3: 323–398. Wente SJ (2013) Nonpharmacologic pediatric pain management in emergency departments: a systematic review of the literature. Journal of Emergency Nursing 39(2): 140–50. Wong C, Lau E, Palozzi L, et al. (2012) Pain management in children: part 1 - Pain assessment tools and a brief review of nonpharmacological and pharmacological treatment options. Canadian Pharmacists Journal 145(5): 222–225.
The effects of three different distraction methods on pain and anxiety in children
Journal of Child Health Care 1–9 ª The Author(s) 2015 Reprints and permission: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1367493515587062 chc.sagepub.com
Nejla Canbulat Sahiner1 and Meltem Demirgoz Bal2
Abstract This study aims to investigate of three different distraction methods (distraction cards, listening to the music of cartoon and balloon inflation) on pain and anxiety relief of children during phlebotomy. This study is a prospective, randomized, and controlled trial. The sample consisted of 6 to 12 years old children who require blood tests. Children were randomized into four groups as the distraction cards, the music, the balloon inflation, and the control. Data were obtained by conducting interviews with the children, their parents, and the observer before and after the procedure. The pain levels of the children were assessed by the parent and observer reports as well as self-report using the Wong-Baker FACES. The anxiety levels of children were assessed by parent and observer reports using Children Fear Scale. One hundred and twenty children (mean age: 9.1 + 1.6 years) were included. The self-reported procedural pain levels showed significant differences among the study groups (p ¼ .040). The distraction card group (2.33 + 3.24) had significantly lower pain levels (p ¼ .057) than the control group (4.53 + 3.23). The procedural child anxiety levels reported by the observer showed a significant difference among the study groups (p ¼ .032). All the forms of distraction significantly reduced pain and anxiety perception. Keywords Acute care, evidence-based practice, pain
Introduction Pain among children and adolescents has been identified as an important public health problem (Roth-Isigkeit et al., 2005). Medical procedures that are applied using a needle, such as 1
Department of Pediatric Nursing, School of Health, Karamanoglu Mehmetbey University, Karaman, Turkey Department of Obstetric and Gynecologic Nursing, School of Health, Karamanoglu Mehmetbey University, Karaman, Turkey 2
Corresponding author: Nejla Canbulat Sahiner, Department of Pediatric Nursing, School of Health, Karamanoglu Mehmetbey University, Karaman 70100, Turkey. Email: [email protected]
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Journal of Child Health Care
venipuncture and immunization, are the most common and important sources of pain for children, causing anxiety, distress, and fear (Blount et al., 2009; Leahy et al., 2008; Uman et al., 2006). If a child’s pain is not treated quickly and effectively, it can cause long-term physical and psychological sequelae. Therefore, it is important for all health-care providers to understand the importance of effective pain control in children (Wong at al., 2012). Pain management includes pharmacological and non-pharmacological approaches (Taddio et al., 2010). Non-pharmacological approaches include distraction activities such as singing, reading, or playing a game (Cohen et al., 2006; Schechter et al., 2007). The benefits of using non-pharmacological methods include decreased pain, distress, and anxiety reported by the parent, child, and/or observer (Wente, 2013). Distraction is a simple and effective technique that directs children’s attention away from noxious stimuli. However, there are a multitude of techniques and technologies associated with distraction (Koller and Goldman, 2012). Recently, it has been shown that using distraction cards is also a beneficial method for dealing with pain during phlebotomy (Canbulat et al., 2014; Inal et al., 2012). Nurses have also been using music to reduce pain for a long time (Balan et al., 2009; Caprilli et al., 2007; Klassen et al., 2008; Kristjansdottir and Kristjansdottir, 2011; Press et al., 2003). It has been shown that distraction with music may have a positive impact on pain and distress for children undergoing intravenous placement (Hartling et al., 2013). Music is inexpensive, easily administered, and free of adverse effects and, as such, can serve as a complementary method for treating perioperative stress and for acute and chronic pain management (Matsota et al., 2013). Additionally, it has been shown that distracting a child by inflating a balloon is also a beneficial method for dealing with pain during phlebotomy (Gupta et al., 2006; Manne et al., 1990). This aim of this study was to compare the effect of distraction by applying distraction cards (Flippits1), listening to the music of a cartoon, and balloon inflation to reduce procedural pain and anxiety during phlebotomy in children between the ages of 6 and 12.
Methods Study design This study was conducted at the Phlebotomy Unit of the Karaman Maternity and Children Hospital. It was designed as a prospective randomized clinical trial that evaluated and compared the effects of distraction cards, listening to cartoon music, and balloon inflation on pain and anxiety levels in children during phlebotomy.
Setting and samples The study population consisted of children aged 6–12 years who requested blood tests. The study sample size was determined by power analysis and was based on previous research (Canbulat et al., 2014; Inal and Kelleci, 2012), with a 1.5-point SD for the experimental group and 2.0 for the control group. With a power of 0.8 and an acceptable type I a error size of .05, each group required 30 individuals. Children were randomized into four groups: the distraction card group, listening to cartoon music group, the balloon inflation group, and the control group. All data were obtained by interviewing the children, their parents, and the observer after the procedure. The phlebotomy process took an average of three minutes (minimum 1 minute and maximum 5 minutes). The current application of this study is that nurses, in the hospitals where we conducted the study, are now using pain relief methods during phlebotomy. Routinely, hospitals in Turkey do not use pharmacological and non-pharmacological methods to reduce pain and anxiety during
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phlebotomy. Parents are allowed but not required to stay with children during phlebotomy. In this study, all parents stay with their children during phlebotomy.
Ethical considerations The study was approved by the ethics committee of Selcuk University, Selcuklu Medical Faculty (2014/21), Konya, Turkey. The aim and method of the study were explained to the children and their parents, and they were informed that if they did not want to continue, they could withdraw from the study without stating a reason.
Measurement/instruments Distraction cards. The distraction cards (Flippits1, MMJ Labs, Atlanta, Georgia, USA) consisted of visual cards of 5 8 cm2, covered with various pictures and shapes. In this method, the children carefully examined the cards, then the researcher asked some questions about those cards to be answered by the children, such as ‘How many ladybugs are there in the picture?’ and ‘How many apes are there in the picture?’ or ‘Can you see the comet?’ The distraction procedure via distraction cards began just before the phlebotomy and continued until the procedure was complete. Because the children’s native language is not English, the translation of the instrument was conducted by an expert who knows both languages. Music playback. The music played during the study was the music of cartoons that are watched mostly by children aged 6–12 years. Fifteen cartoons in total were used in the room where blood was taken, and the kids were asked to which cartoon the music belonged. It was skipped to another song when the kids recognized the music. This process continued while blood was taken. Balloon inflation. The kids were given whatever color balloons they wanted. They were asked to inflate the balloon before process and kept on inflating after the process was concluded, at which time the kids were given the balloons they inflated. Control group. The kids in this group were allowed to keep their family near. The routine bloodtaking procedure was applied. The level of pain resulting from the applied procedure in each child was assessed by the selfreports as well as the parent and observer reports, using the Wong-Baker FACES (WB-FACES) pain rating scale. The WB-FACES scale is a 0 to 10 scale, showing six cartoon faces that range from a neutral expression (0 ¼ very happy/no hurt) to a crying face (10 ¼ hurts as much as you can imagine). Children Fear Scale (CFS) was used to evaluate the children’s level of anxiety. CFS is a 0 to 4 scale, showing five cartoon faces that range from a neutral expression (0 ¼ no anxiety) to a frightened face (4 ¼ severe anxiety). Pre-procedural and procedural pain, as well as anxiety, for all children was evaluated using CFS by both parents and the researchers.
Data collection/procedure This study was conducted with two volunteer nurses trained by the researcher. The nurses had a minimum of five years of experience in pediatric patient care and venipuncture. The nurses did not
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have any conflict of interest. Before the procedure, a pediatrician made clinical decision for phlebotomy. For patients agreeing to participate, background demographic information, medical history, recent analgesics, and body mass index (BMI) were collected via self-report forms. Prior to randomization, the researcher read a standard script to explain the pain and anxiety measures. Both parents and children indicated that they understood how to use the measures. The first nurse, the ‘observer nurse’, evaluated the pre-procedural and procedural anxiety and procedural pain for all children using the 0–4 CFS for anxiety and the 0–10 WB-FACES scale for pain. The second nurse conducted the phlebotomy procedure for all children. The parents and observers assessed the children’s anxiety levels. One hundred and twenty children were randomized on the basis of a computer-generated table of random numbers into three equal groups. After the assignment, children and their parents moved into the phlebotomy unit for the procedure. Venipunctures were performed between 08:00–12:00 hours and 12:00–16:00 hours with a vacutainer and a 21 G needle. The same nurse conducted all distraction methods for all children. All parents stayed with their children during the procedure. The procedure was considered successful if blood started running into the tube in 15 seconds. If the blood specimen collection could not be done in the first attempt, the procedure was attempted in the distal part of the same arm. When second attempts were needed, the distraction methods continued from the beginning of the first attempt until the end of the last attempt. After the procedure, the children’s pain levels were assessed by self-report and by parents’ and the observer’s report.
Data analysis All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS Inc., Chicago, Illinois, USA) version 21.0 for Windows. Baseline characteristics among the groups, and all parametric data were analyzed by employing the 2 test and Student’s t-test. Statistical significance was set at p < .05. Parametric data such as the level of pain in children was compared with one-way analysis of variance. If the p value was significant (p < .05), a Bonferroni test was performed as a post hoc analysis.
Results Comparison of the groups in terms of some variables One hundred and twenty children (57 (47.5%) female and 63 (52.5%) male) were included in the present study. The mean age of the children was 9.1 + 1.6 years (range: 6–12 years). The children were randomized into the listening to music (n ¼ 30), the distraction cards (n ¼ 30), the balloon inflation (n ¼ 30), and the control (n ¼ 30) groups. Table 1 presents the characteristics of the children. Age, gender, BMI, pre-procedural anxiety levels of children, and success of phlebotomy attempts were similar among the four groups. There were no significant differences among pre-procedural anxiety levels of the study groups in terms of self, parent, and observer reports (p ¼ .099, p ¼ .300, and p ¼ .811, respectively).
Comparison of the groups in terms of pain levels The evaluation of procedural pain levels during phlebotomy collection is presented in Table 2. The self-reported procedural pain levels showed significant differences among the study groups (p ¼ .040). The distraction card group (2.33 + 3.24) had significantly lower pain levels (p ¼ .057)
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Table 1. Baseline characteristics and pre-procedural anxiety scores of the study groups. Distraction card group (n ¼ 30) Gender Female 15 (50) Male 15 (50) BMI 29.03 + 7.6 Pre-procedural anxiety levels Self-reported 1.67 + 1.47 Parent-reported 1.23 + 1.27 Observer-reported 1.53 + 1.52 Success of phlebotomy attempt In first attempt 27 (90) In second attempt 3 (10)
Balloon inflation group (n ¼ 30)
Listening music of cartoon group (n ¼ 30)
Control group (n ¼ 30)
12 (40) 18 (60) 25.97 + 8.05
16 (53.3) 14 (46.7) 25.23 + 8.87
14 (46.7) 16 (53.3) 29.70 + 10.3
0.935
2.60 + 2.14 1.37 + 1.27 1.10 + 2.85
1.70 + 1.41 1.83 + 1.31 1.40 + 1.35
2.10 + 1.37 1.33 + 1.39 1.50 + 1.50
0.099 0.300 0.811
25 (83.3) 5 (16.7)
29 (96.7) 1 (3.3)
0.509
27 (90) 3 (10)
p Value
0.132
BMI: body mass index. Note: Data are represented as number (percentage) or mean + standard deviation, where appropriate.
than the control group (4.53 + 3.23). There were also no significant differences in both the parentand observer-reported procedural pain levels among the study groups (p > .05 for each), and all the distraction groups’ (distraction card, listening to cartoon music, and balloon inflation) pain levels were lower than the control group (p ¼ .057, p ¼ .108, p ¼ .410, respectively). The parent-reported pain levels in the distraction card group were also significantly lower than that of the control group (p ¼ .055).
Comparison of the groups in terms of anxiety levels The procedural anxiety levels during phlebotomy are presented in Table 3. The procedural child anxiety levels reported by the observer showed a significant difference among the study groups (p ¼ .032). The anxiety levels in the balloon inflation group were significantly lower than the other groups (distraction card, listening to cartoon music, and control; p ¼ .049), whereas the scores in the distraction card and listening to cartoon music groups were also lower than the control group.
Discussion Pain experienced during the medical procedures that are routinely performed in hospitals, such as phlebotomy and immunization, may cause stress, fear, and anxiety in children (Cassidy et al., 2001; Razzaq, 2006). The American Society for Pain Management Nursing recommends that optimal pain control before and during painful procedures needs to be provided. Therefore, pharmacological and non-pharmacological approaches should be used to control acquired pain and the resulting future anxiety. Currently, a number of interventions are used to reduce pain perception during medical procedures, and distraction is one of the most commonly used and effective ones (Schechter et al., 2007). Distraction methods are widely used to reduce procedural pain and anxiety (Canbulat et al., 2014; He et al., 2005; Inal and Kelleci, 2012; Tu¨fekci et al., 2009). The methods are performed in various ways during medical procedures to divert the patient’s attention (Arts et al., 1994; Cassidy
6 3.87 + 3.631 3.13 + 2.76 4.13 + 3.40
4.53 + 3.23 3.53 + 2.95 4.07 + 2.90 0.040 0.055 0.062
0.057*
p Value
0.108*
0.410*
1.000*
0.77 + 1.27 0.40 + 0.77
Note: Data are represented as mean + standard deviation. *Bonferroni test results.
Parent-reported 0.80 + 1.21 Observer-reported 0.83 + 1.23
0.90 + 1.29 1.17 + 1.28
1.27 + 1.41 1.23 + 1.40
0.429 0.032
0.987*
0.049*
0.89*
1.000*
Listening music Balloon Listening music Distraction Balloon Distraction card group inflation group of cartoon group Control group card group inflation group of cartoon group Control group (n ¼ 30) (n ¼ 30) (n ¼ 30) (n ¼ 30) (n ¼ 30) p Value (n ¼ 30) (n ¼ 30) (n ¼ 30)
Table 3. Comparison of procedural anxiety scores of the study groups.
WB-FACES: Wong-Baker FACES. Note: Data are represented as mean + standard deviation. *Bonferroni test results.
Procedural anxiety scores
p Value
Listening music Balloon Listening music Distraction Balloon Distraction card group inflation group of cartoon group Control group card group inflation group of cartoon group Control group (n ¼ 30) (n ¼ 30) (n ¼ 30) (n ¼ 30) (n ¼ 30) p Value (n ¼ 30) (n ¼ 30) (n ¼ 30)
According to WB-FACES Self-reported 2.33 + 3.24 4.33 + 23.11 Parent-reported 1.87 + 2.96 2.513 + 1.96 Observer-reported 2.20 + 3.21 2.60 + 4.14
Procedural pain scores
Table 2. Comparison of procedural pain scores of the study groups.
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et al., 2002; Mason et al., 1999; Tu¨fekci et al., 2009). Recently, Inal and Kelleci (2012) and Canbulat et al. (2014) demonstrated that distraction cards (Flippits) were very effective in reducing procedural pain and anxiety in children during phlebotomy. In this study, in parallel to the literature of distraction during blood collection, the distraction card group had lower pain scores compared to other groups (listening to cartoon music and balloon group); additionally, self-reported and parentreported pain according to the difference was found to be statistically significant. Several studies have reported that for many patients music reduced anxiety and aggressive behavior (Balan et al., 2009; Caprill et al., 2007; Klassen et al., 2008; Kristjansdottir and Kristjansdottir, 2011; Press et al., 2003). Press et al. (2003) examined the effect of music in reducing pain during blood collection from children aged 6 to 16 years in the emergency department and found no significant differences compared with the control group. It was compared the efficacy of a local anesthetic cream with music distraction in reducing or preventing pain from needle puncture (intravenous cannulation) in children (Arts et al., 1994). The results showed that lidocaine–prilocaine emulsion was highly effective in preventing pain from venipunctures in young children. Balan et al. (2009) compared the comparative efficacy of local anesthetic cream, Indian classical instrumental music, and placebo in reducing pain due to venipuncture in children. The results showed that pain experienced during venipuncture was significantly reduced using EMLA or Indian classical instrumental music. Caprill and colleagues (2007) aimed to determine whether the presence of musicians, who had attended specific training to work in medical settings, could reduce distress and pain in children who were giving blood samples. Their results demonstrated that songs and music performed by professional musicians had a beneficial effect in reducing distress before, during, and after blood sampling. Kristjansdottir and Kristjansdottir (2011) conducted a study on 128 adolescents during inactivated polio vaccination in randomized, controlled trials. The adolescents were divided into three groups: musical distraction with headphones, musical distraction without headphones, and standard care control. After testing for covariates, their results showed that the adolescents who received musical distraction were less likely to report pain compared with the control group. When the musical distraction techniques were compared, the elimination of headphones emerged as a significant predictor of no pain, which suggests that an easy and practical musical distraction intervention, implemented without headphones, can give some pain relief. In the present study, consistent with the previously reported musical distraction groups, the group who listened to the cartoon soundtrack music had lower pain and anxiety scores compared with the control group; however, there was no statistically significant difference between the distraction group and the control group. One of the frequently used methods of pain and anxiety reduction is balloon inflation. Manne et al. (1990) reported that it was an effective method in reducing the family’s and the child’s stress. French et al. (1994) and Blount et al. (1992) reported that a simple distraction technique (party blower and deep breathing) can be effective in helping children cope with the pain of immunization. Gupta et al. (2006) showed that children’s pain levels were significantly lower in the balloon inflation group than in the control group. As in this study, other research groups have found that balloon inflation significantly lowered procedural anxiety scores, thus providing an effective technique during painful medical procedures. It is widely accepted that most children who previously experienced a painful medical procedure are fearful and anxious about future procedures. Therefore, decreasing the emotional effects of painful procedures in clinical practice with better pain control is important for children. In order to avoid the future undesirable effects of painful medical procedures, a successful pain control technique should be implemented.
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Conclusion All the forms of distraction (distraction cards, listening to cartoon music, and balloon inflation) significantly reduced pain and anxiety perception. Nurses need to be aware of procedural anxiety and pain during phlebotomy. Distraction methods should be implemented to decrease anxiety and pain in children. This study contributes to the literature on non-pharmacological pain relief methods and should be replicated in more settings to see whether the findings are similar. Acknowledgments We are also grateful to the subjects of this study for agreeing to participate in this study. Authors’ Note Authors NCS and MDB contributed to the study design, data collection, and manuscript preparation and NCS helped in data analysis. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. References Arts SE, Abu-Saad HH, Champion GD, et al. (1994) Age-related response to lidocaine-prilocaine (EMLA) emulsion and effect of music distraction on the pain of intravenous cannulation. Pediatrics 93(5): 797–801. Balan R, Bavdekar SB and Jadhav S (2009) Can Indian classical instrumental music reduce pain felt during venepuncture? Indian Journal of Pediatrics 76: 469–473. Blount RL, Bachanas PJ, Powers SW, et al. (1992) Training children to cope and parents to coach them during routine immunizations: effects on child, parent, and staff behaviors. Behavior Therapy 23(4): 689–705. Blount RL, Zempsky WT, Jaaniste T, et al. (2009) Management of pain and distress due to medical procedures. In: Roberts MC and Steele R (eds) Handbook of Pediatric Psychology. 4th ed. New York: Guilford Press, pp. 171–188. _ S and Sonmezer H (2014) Efficacy of distraction methods on procedural pain and anxiety by Canbulat N, Inal applying distraction cards and kaleidoscope in children. Asian Nursing Research 8: 23–28. Caprilli S, Anastasi F, Grotto RP, et al. (2007) Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. Journal of Developmental and Behavioral Pediatrics 28: 399–403. Cassidy KL, Reid GJ, McGrath PJ, et al. (2001) A randomized double-blind, placebo-controlled trial of the EMLA patch for the reduction of pain associated with intramuscular injection in four to six-year-old children. Acta Paediatrica 90(11): 1329–1336. Cassidy KL, Reid GJ, McGrath PJ, et al. (2002) Watch needle, watch TV: audiovisual distraction in preschool immunization. Pain Medicine 3(2): 108–118. Cohen LL, Bernard RS, McClellan CB, et al. (2006) Topical anesthesia versus distraction for infants’ immunization distress: evaluation with 6-month follow-up. Children’s Health Care 35(2): 103–121. French GM, Painter EC and Coury DL (1994) Blowing away shot pain: a technique for pain management during immunization. Pediatrics 93(3): 384–388.
Sahiner and Bal
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Gupta D, Agarwal A, Dhiraaj S, et al. (2006) An evaluation of efficacy of balloon inflation on venous cannulation pain in children: a prospective, randomized, controlled study. Anesthesia & Analgesia 102(5): 1372–1375. Hartling L, Newton AS, Liang Y, et al. (2013) Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. Journal of the American Medical Association pediatrics 167(9): 826–35. He HG, Po¨lkki T, Vehvila¨inen-Julkunen K, et al. (2005) Chinese nurses’ use of non-pharmacological methods in children’s postoperative pain relief. Journal of Advanced Nursing 51(4): 335–342. Inal S and Kelleci M (2012) Distracting children during blood draw: looking through distraction cards is effective in pain relief of children during blood draw. International Journal of Nursing Practice 18(2): 210–219. Klassen JA, Liang Y, Tjosvold L, et al. (2008) Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambulatory Pediatrics 8: 117–128. Koller D and Goldman RD (2012) Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs 27(6): 652–681. Kristjansdottir O and Kristjansdottir G (2011) Randomized clinical trial of musical distraction with and without headphones for adolescents’ immunization pain. Scandinavian Journal of Caring Sciences 25: 19–26. Leahy S, Kennedy RM, Hesselgrave J, et al. (2008) On the front lines: lessons learned in implementing multidisciplinary peripheral venous access pain-management programs pediatric hospitals. Pediatrics 122(Suppl 3): 161–170. Manne SL, Redd WH, Jacobsen PB, et al. (1990) Behavioral intervention to reduce child and parent distress during venipuncture. Journal of Consulting and Clinical Psychology 58: 565–572. Mason S, Johnson MH and Woolley C (1999) A comparison of distractors for controlling distress in young children during medical procedures. Journal of Clinical Psychology in Medical Settings 6: 239–248. Matsota P, Christodoulopoulou T, Smyrnioti ME, et al. (2013) Music’s use for anesthesia and analgesia. Journal of Alternative and Complementary Medicine 19(4): 298–307. Press J, Gidron Y, Maimon M, et al. (2003) Effects of active distraction on pain of children undergoing venipuncture: who benefits from it? The Pain Clinic 15: 261–269. Razzaq Q (2006) The underuse of analgesia and sedation in pediatric emergency medicine. Annals of Saudi Medicine 26(5): 375–381. Roth-Isigkeit A, Thyen U, Sto¨ven H, et al. (2005) Pain among children and adolescents: restrictions in daily living and triggering factors. Pediatrics 115(2): e152–e162. Schechter NL, Zempsky WT, Cohen LL, et al. (2007) Pain reduction during pediatric immunizations: evidence-based review and recommendations. Pediatrics 119: 1184–1198. Taddio A, Appleton M, Bortolussi R, et al. (2010) Reducing the pain of childhood vaccination: an evidencebased clinical practice guideline. Canadian Medical Association Journal 182: 43–55. Tu¨fekci FG, Celebiog˘lu A and Ku¨c¸u¨kog˘lu S (2009) Turkish children loved distraction: using kaleidoscope to reduce perceived pain during venipuncture. Journal of Clinical Nursing 18(15): 2180–2186. Uman LS, Chambers CT, McGrath PJ, et al. (2006) Psychological interventions for needle-related procedural pain and distress in children and adolescents. Evidence-Based Child Health: A Cochrane Review Journal 3: 323–398. Wente SJ (2013) Nonpharmacologic pediatric pain management in emergency departments: a systematic review of the literature. Journal of Emergency Nursing 39(2): 140–50. Wong C, Lau E, Palozzi L, et al. (2012) Pain management in children: part 1 - Pain assessment tools and a brief review of nonpharmacological and pharmacological treatment options. Canadian Pharmacists Journal 145(5): 222–225.
