Journal of Pediatric Nursing (2015) 30, 294–300
Quality Improvement Project to Reduce Pain and Distress Associated With Immunization Visits in Pediatric Primary Care1,2 Stephanie Burgess, DNP ⁎, Donna G. Nativio, PhD, CRNP, FAAN, Joyce E. Penrose, DrPH, CRNP, FNP-BC University of Pittsburgh School of Nursing, Pittsburgh, PA Received 10 May 2014; revised 2 September 2014; accepted 5 September 2014
Key words: Distraction; Immunization; Anesthetic spray
This quality improvement project implemented an evidence-based immunization protocol aimed at decreasing pain and distress associated with immunizations for children ages 4 to 6 by utilizing distraction and a benzocaine-based anesthetic spray. The original protocol is used at a large, universitybased pediatric primary care hospital. A convenience sample of 30 children from a community-based healthcare center was utilized to assess effectiveness in alternate settings. This quasi-experimental project collected survey information from child participants and consenting caregivers. Statistical analysis by paired t-test indicated a statistically significant decrease in reported distress by both the child and the caregiver utilizing the immunization protocol. © 2015 Elsevier Inc. All rights reserved.
Background Under immunization of children has become more prominent in the United States as more parents are following alternative vaccination schedules or refusing vaccinations all together. Evidence has linked vaccine refusal with outbreaks of vaccine preventable diseases (Omer, Salmon, Orenstein, deHart, & Halsey, 2009). A study by Atwell et al. (2013), further suggests clusters of unvaccinated individuals “may have been 1 of several factors in the 2010 California pertussis resurgence” (p. 624). The Centers for Disease Control and Prevention currently recommends children to be vaccinated against sixteen different illnesses. Most vaccinations are 1
No extramural funding or commercial financial support has been utilized in this study. 2 The paper has not previously been presented. ⁎ Corresponding author: Stephanie Burgess, DNP. E-mail addresses: [email protected] http://dx.doi.org/10.1016/j.pedn.2014.09.002 0882-5963/© 2015 Elsevier Inc. All rights reserved.
given as multi-dose series resulting in as many as 33 injections by age 6 years (CDC, 2014). The immunization protocol utilized by a primary care office can greatly impact the overall immunization experience. Stockwell, Irigoyen, Martinez, and Findley (2011) discovered an association between previous negative immunization experiences and under immunization in children. These findings imply that childhood experiences with immunizations have the potential to impact the incidence of vaccine preventable diseases. Therefore, steps should be taken to decrease painful and distressing immunization experiences to increase on-time vaccination. Furthermore, a “reduction in perceived pain or anxiety by the parent may promote timely return for future vaccinations” (Luthy, Beckstrand, & Pulsipher, 2013, p. 352). Stress reduction is a common technique utilized during painful and distressing situations. In existing studies comparing stress reduction techniques, distraction appears to be a method of choice for pediatric patients. Providing appropriate distraction creates the potential to reduce the
TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATION overall distress exhibited by the patients as well as their caregiver (Manne, Redd, Jacobsen, Gorfinkle, & Schorr, 1990). Manne et al. (1990) used party blowers as a means of distraction in children aged 3 to 9 years undergoing venipuncture while other studies have used touch screen electronic toys and virtual reality glasses. Reis and Holubkov (1997) studied the utilization of a.) distraction alone versus b.) distraction combined with a vapocoolant spray and c.) distraction combined with an eutectic mixture of local anesthetics (EMLA) cream during immunization procedures. Their findings indicate that using a method of distraction combined with the use of a vapocoolant spray is an effective, fast and inexpensive way to reduce the pain and distress associated with immunizations. Immunizations are a recommended and beneficial procedure. Rarely are steps taken to decrease the associated pain and distress despite available evidence-based protocols due to time constraints (Weissenstein, Straeter, Villalon, Luchter, & Bittmann, 2013). Pain and distress are known barriers to meeting recommended immunization rates. The health care center where this project was implemented had not been using a standard protocol for immunizations aimed at decreasing pain and distress. To help lessen those aforementioned barriers to meeting recommended immunization rates, an evidence-based immunization protocol developed for and still in use at a large, university based pediatric primary care hospital was utilized. The goal of this project was to decrease pain and distress for both the patient and the accompanying caregiver by implementing an immunization protocol utilizing an active physical distracter and a benzocaine-based anesthetic spray with immunizations visits in an urban, community-based, primary care center.
295
Staff Education To educate the staff in preparation for participating in this project, a lecture focusing on the importance of pain and distress reduction to aid immunization compliance and timeliness was provided to the two registered nurses, a nurse practitioner and a medical assistant. The project protocol was described, and the staff's role and participation was discussed. They were allowed to practice with the materials, and their questions were addressed.
Intervention
This quality improvement project, guided by the Reis and Holubkov (1997) study findings, was completed in a small, urban, community-based health care center situated in a medically underserved neighborhood. The majority of patients have government funded insurance and benefit from the Vaccines for Children program where they receive vaccines at no cost. The pediatrician in the center has been serving this community for nearly 25 years, the nurse practitioner and medical assistant have been there 1 year and the registered nurses have each provided 2 years of service.
All children aged 4 to 6 years, receiving at least one immunization were eligible to participate unless there was a known sensitivity to benzocaine. Once a patient in the appropriate age range was identified on the schedule, a chart review was completed, prior to their scheduled appointment, to identify any known allergy or sensitivity to benzocaine. The patient/caregiver dyads were approached in their exam room after their immunizations were ordered by the MD or NP to assess their willingness and ability to participate in the project. A script was utilized to explain the project to the dyad. If they agreed to participate, a consent form, written at a fifth grade reading level, was signed and kept on file. A copy was provided to the signer. After consent was gained, the dyad was instructed on how to fill out the short pre-immunization survey consisting of three questions which were read to the caregiver by the first author (see Box A). Before immunization, all children, were provided with a party blower as a distraction and instructed to blow it at the RN's, MA's or caregiver's moving hand, as if it were a target, during the procedure. Practice blowing was encouraged prior to the immunization. The staff administering the injection sprayed the injection site with the benzocaine-based cooling spray for 5 to 10 seconds at least 3 inches away from the skin, waited 20 to 30 seconds, cleaned the site with alcohol and administered the injection per manufacturer's recommended route while facilitating the party blower use. Following immunization, the caregiver completed the postimmunization survey consisting of three questions, nearly identical to the pretest, which were also read to the caregiver (see Box B). A cover sheet identifying the child's age, sex, reason for visit, accompanying caregiver, additional members in the room, immunization(s) received and who administered the immunization was completed, and all data forms were placed in a manila envelope to promote organization and confidentiality and were kept in a locked file box to await analysis.
Human Subject Protection
Data Collection
The University of Pittsburgh Institutional Review Board considered this project to be exempt. Written consent was obtained from the caregivers of the participating patients.
Prior to immunization, the first author collected historical data from the accompanying caregiver utilizing Visual Analog Scales (VASs). These scales have been found to be
Methods Setting
296
S. Burgess et al.
Pre-Immunization Ratings 1.) Please mark a line to indicate how upset your child was after the last immunization they received.
Not At All Upset
Extremely Upset
2.) Please mark a line to indicate how upset you were after the last immunization your child received.
Not At All Upset
Extremely Upset
3.) Please help your child circle the face which best shows how they are currently feeling.
Box A
Pre-immunization ratings.
reliable tools to assign number values to typically subjective data such as pain and distress with an intraclass correlation coefficient of 0.97 [95% CI = 0.96 to 0.98] (Bijur, Silver, & Gallagher, 2001). VASs are horizontal lines exactly 100 mm in length with a descriptor phrase on each end of the line. The descriptors are typically opposite ends of a spectrum such as “not at all upset” and “extremely upset” and, therefore, create a continuum of possible answers. The individual being assessed marks a vertical line somewhere on the continuum of the VAS which they feel best describes how they feel. This mark is then measured, in mm, from the left margin, to numerically describe their answer. The caregivers were asked to identify the typical level of distress expressed by the child as well as the typical level of distress they experience as the observing caregiver by marking a line on sliding scale labeled with descriptors from “not at all upset” to “extremely upset”. Following immunization, utilizing a VAS with the aforementioned sliding scale, the caregiver was asked to identify the level of distress expressed by the child as well as the level of distress they experienced during the current immunization. Additionally, pre- and post-immunization data on pain were collected by the first author directly from the child utilizing the Wong-Baker FACES Pain Rating Scale to
quantify any change in pain rating associated with the immunization procedure. The Wong-Baker FACES Pain Rating Scale is a widely utilized measurement tool which allows children to effectively describe the pain they are feeling. This scale has been found to be both reliable, with a statistically significant test–retest reliability of r = .83, and valid, with a statistically significant concurrent validity when compared to both a word graphic scale (r = .63) and a numerical scale (r = .75), for the age range being assessed in the project (Keck, Gerkensmeyer, Joyce, & Schade, 1996). Furthermore, in a study by Wong and Baker (1988) comparing six separate pain assessment scales, the FACES Pain Rating Scale scored the highest preference in children ages 3 to 7 years. The scale consists of a series of six faces with increasing levels of discomfort displayed on them. A child is to select the face which best illustrates how they feel. Each face has an associated number which allows their pain to be numerically described. A cover sheet identifying the child's age, sex, reason for visit, accompanying caregiver, additional members in the room, immunization(s) received and who administered the immunization was completed by the first author. Following the completion of data collection, the RNs and MA participating in the administration of immunizations
TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATION
297
Post-Immunization Ratings 1.) Please mark a line to indicate how upset your child was after today’s immunizations.
Not At All Upset
Extremely Upset
2.) Please mark a line to indicate how upset you were after your child’s immunizations today.
Not At All Upset
Extremely Upset
3.) Please help your child circle the face which best shows how they are currently feeling.
Box B
Post-immunization ratings.
were given a Likert scale survey to assess the feasibility of the protocol which was created by the first author (see Box C). On this Likert scale, the answer choices ranged from “1: strongly disagree” to “5: strongly agree”. They were asked to respond to the following statements, a.) “Our current method of immunization for children, ages 4 to 6, works well in our setting.” b.) “I am willing to try another method to improve the outcome for the child and caregiver.” c.) “A method of immunization using distraction and a benzocaine-based vapocoolant spray has the potential to improve our immunization procedure.” d.) “I am likely to continue to use an immunization procedure using distraction and benzocaine-based vapocoolant spray in the future.” and e.) “I think it is realistic to continue to use this immunization procedure in our setting.”
Data Analysis Data were analyzed utilizing SPSS version 19. The preand post-immunization data from the VAS and the WongBaker FACES Pain Rating Scale underwent paired t-test analysis. The feasibility data from the staff was analyzed for measures of central tendency.
Results Recruitment took place from September to mid-October 2013. During that time, a total of 30 dyads were approached for involvement in this project, and all 30 agreed to participate. They are described in Table 1. Of the 30 participants, 50% were age 4, 26.6% were age 5 and 23.3% were age 6. With 12 males and 18 females, the majority were present with their mother (80%) while others presented with their father (6.6%), grandmother (6.6%), mother & father (3.3%), and foster mother (3.3%). Eighteen presented for an annual well child visit, 7 for an acute visit, and 5 for other visits. As for the number of vaccinations received, 60% received a single vaccination, 10% received two, 3.3% received three, 20% received four, and 6.6% received five vaccinations. There were no additional family members in the room for 40% of the dyads, another 40% had one additional family member, 16.6% had two additional family members and 3.3% had three additional family members in the room. Table 2 summarizes the pre- and post-intervention data for all participating dyads. Age, sex and number of
298
S. Burgess et al. 1.) Our current method of immunization for children, ages 4 to 6, works well in our setting. 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
2.) I am willing to try another method to improve the outcome for the child and caregiver. 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
3.) A method of immunization using distraction and a benzocaine-based vapocoolant spray has the potential to improve our immunization procedure. 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
4.) I am likely to continue to use an immunization procedure using distraction and benzocaine-based vapocoolant spray in the future. 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
5.) I think it is realistic to continue to use this immunization procedure in our setting. 1 Strongly Disagree
2 Disagree
3 Neutral
Box C
Demographics. n (%)
Age
Sex Accompanying caregiver
Type of visit
Vaccinations received
Additional family members in room
4 5 6 Male Female Mother Father Grandmother Mother & father Foster mother Annual well child Acute visit Other 1 2 3 4 5 0 1 2 3
15 8 7 12 18 24 2 2 1 1 18 7 5 18 3 1 6 2 12 12 5 1
(50) (26.7) (23.3) (40) (60) (80) (6.7) (6.7) (3.3) (3.3) (60) (23.3) (16.7) (60) (10) (3.3) (20) (6.7) (40) (40) (16.7) (3.3)
5 Strongly Agree
Feasibility survey.
immunizations have also been listed in the table to aid in comparison. The staff participating in the administration of the immunizations were given the five question Likert scale feasibility survey previously described. The findings are summarized in Table 3. For the first question, “Our current method of immunization for children, ages 4 to 6, works well
Table 1
4 Agree
in our setting.”, the average response was 3.67. The second question, “I am willing to try another method to improve the outcome for the child and caregiver.”, had an average response of 4. The third question, “A method of immunization using distraction and a benzocaine-based vapocoolant spray has the potential to improve our immunization procedure.”, had an average response of 4.67 while the fourth question, “I am likely to continue to use an immunization procedure using distraction and benzocainebased vapocoolant spray in the future.”, had an average response of 4.67. Finally, for the fifth question, “I think it is realistic to continue to use this immunization procedure in our setting.”, the average response was 4.67. The paired-t test analysis of the pre- and post-intervention child distress ratings produced a t = 2.985 with a 2-tailed significance of p = .006 (Table 4). This indicates a statistically significant decrease in the child's reported distress following an immunization procedure which utilized distraction and a benzocaine-based anesthetic spray as compared to an immunization procedure which did not utilize distraction and a benzocaine-based anesthetic spray. The paired-t test analysis of the pre- and post-intervention caregiver distress ratings produces a t = 3.226 with a 2-tailed significance of p = .003. This also indicates a statistically significant decrease in the caregiver's reported distress following an immunization procedure which utilized distraction and a benzocaine-based anesthetic spray as compared to an immunization procedure which did not utilize distraction and a benzocaine-based anesthetic spray. For the paired-t test analysis of the pre- and postintervention pain ratings, a t = − .348 with a 2-tailed significance of p = .730 was found. This indicates that there was not a statistically significant increase in the
TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATION Table 2
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Mean
299
Pre- and post-intervention data. Age Sex Number of Caregiver's estimation of immunizations child's response received Pre-intervention Post-intervention distress rating distress rating
Caregiver's response
5 5 4 4 4 4 4 6 5 4 5 5 6 4 4 5 4 6 6 4 4 4 4 4 4 6 6 5 6 5
4 9 82 84 78 20 60 14 12 67 0 0 55 6 87 0 79 64 0 100 32 0 50 100 79 9 9 5 51 0 38.53
F F M F F M F M M M M M F F F F F F M F M M M F F F F M F F
4 1 1 1 1 4 4 1 1 4 1 1 1 5 4 1 2 1 1 1 5 2 2 4 3 1 1 1 1 1
55 53 57 73 36 100 21 12 10 40 52 100 25 68 70 43 79 78 0 0 29 0 52 100 100 8 8 79 100 45 49.77
24 7 5 18 10 51 11 8 9 97 0 0 38 92 94 0 90 66 0 0 35 16 26 54 75 12 15 38 74 0 32.17
reported level of pain for the child before the immunization procedure as compared to the reported level of pain after the procedure. Table 3
Feasibility survey responses.
Question
Average response
Our current method of immunization for children, ages 4 to 6, works well in our setting. I am willing to try another method to improve the outcome for the child and caregiver. A method of immunization using distraction and a benzocaine-based vapocoolant spray has the potential to improve our immunization procedure. I am likely to continue to use an immunization procedure using distraction and benzocaine-based vapocoolant spray in the future. I think it is realistic to continue to use this immunization procedure in our setting.
3.67 4
Pre-intervention Post-intervention Pre- intervention Post-intervention distress rating distress rating pain rating pain rating 2 2 9 7 17 0 8 13 12 87 0 0 43 6 94 0 44 50 0 55 20 0 30 31 79 13 14 3 50 0 22.97
4.67
6 0 0 0 0 2 2 4 0 8 0 8 8 2 0 0 0 2 2 0 0 0 8 0 10 4 2 4 0 2 2.47
0 0 0 0 0 6 0 0 0 10 0 2 10 6 8 0 6 4 0 2 4 2 6 4 0 0 0 2 10 0 2.73
The nursing staff indicated that they are likely to continue to use the immunization procedure with distraction and a benzocaine-based anesthetic spray. Furthermore, they also believe that is it strongly realistic and feasible to do so in their setting.
Table 4 Paired-t test data comparing pre- and post-intervention data. t
4.67
4.67
Child's pain rating
df Significance (2-tailed)
Pre- vs. post-intervention child 2.985 29 .006 ⁎ distress rating Pre- vs. post-intervention caregiver 3.226 29 .003 ⁎ distress rating Pre- vs. post-intervention pain rating − .348 29 .730 ⁎ = Significant at p b 0.05.
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Discussion While there was no statistically significant change in pain rating, this is a clinically significant finding. Minimizing the amount of pain inflicted with immunizations, which are typically a painful, tearful experience, is an asset for this protocol. This finding coupled with the statistically significant decrease in distress supports the utilization of this evidencebased immunization protocol to promote a limitation of pain and a decrease in distress associated with immunizations for this setting. All staff participating in this project supports this protocol, and the patient population appears to support this protocol as well as all dyads approached for participation in this project agreed to participate. The protocol is not time consuming and is easily integrated into the staff's immunization process. As found in previous studies, distraction and, specifically, party blowers work well as a method of limiting pain and distress associated with painful procedures in those aged 4 to 6 years. Furthermore, despite using an alternative spray, this project supports Reis and Holubkov (1997)'s findings which indicate using a method of distraction combined with the use of a vapocoolant spray is an effective, fast and inexpensive way to reduce the pain and distress associated with immunizations. While the findings from this project could be attributed to the novelty of the party blower and anesthetic spray, only further study would be able to ascertain this.
Conclusions Finding an immunization procedure that not only garners staff buy-in but also produces statistically significant less distress for both the child and the caregiver is a positive step toward promoting on-time immunization. If used consistently and properly, this immunization procedure has the potential to decrease negative immunization experiences, increase on-time immunization and decrease the incidence of vaccine preventable diseases. If the health care center where this project was conducted adopts this protocol as their standard procedure, periodic monitoring will need to be conducted to ensure that the
S. Burgess et al. protocol is being utilized correctly. It will also need to be adopted into the new staff orientation process. In the future, further study could evaluate the effectiveness of the protocol outside of the 4 to 6 year age range. It may be beneficial to the overall protocol to have options of physical distractors for the child or caregiver to select which they like best. This may improve the impact of the distractor and allow caregivers to select a method which is appropriate for their child. Furthermore, it may prove beneficial to conduct additional studies to identify any significant impact that the number of immunizations and even the number of individuals in the room may have on the child's level of pain and distress.
References Atwell, J. E., Otterloo, J. V., Zipprich, J., Winter, K., Harriman, K., Salmon, D. A., et al. (2013). Nonmedical vaccine exemptions and pertussis in California, 2010. Pediatrics, 132, 624–630. Bijur, P. E., Silver, W., & Gallagher, J. (2001). Reliability of the visual analog scale for measurement of acute pain. Academic Emergency Medicine, 8, 1153–1157. Centers for Disease Control and Prevention (2014). Birth – 18 years & “catch-up” immunization schedules. Retrieved from. http://www.cdc. gov/vaccines/schedules/hcp/child-adolescent.html. Keck, J., Gerkensmeyer, J., Joyce, B., & Schade, J. (1996). Reliability and validity of the faces and word descriptor scales to measure procedural pain. Journal of Pediatric Nursing, 11, 368–374. Luthy, K. E., Beckstrand, R. L., & Pulsipher, A. (2013). Evaluation of methods to relieve parental perceptions of vaccine-associated pain and anxiety in children: A pilot study. Journal of Pediatric Health Care, 27, 351–358. Manne, S., Redd, W., Jacobsen, P., Gorfinkle, K., & Schorr, O. (1990). Behavioral intervention to reduce child and parent distress during venipunture. Journal of Consulting and Clinical Psychology, 58, 565–572. Omer, S., Salmon, D., Orenstein, W., deHart, P., & Halsey, N. (2009). Vaccine refusal, mandatory immunization, and the risks of vaccine-preventable diseases. New England Journal of Medicine, 360, 1981–1988. Reis, E., & Holubkov, R. (1997). Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics, 100, e5. Stockwell, M., Irigoyen, M., Martinez, R., & Findley, S. (2011). How parents’ negative experiences at immunization visits affect child immunization status in a community in New York City. Public Health Reports, 126, 24–32. Weissenstein, A., Straeter, A., Villalon, G., Luchter, E., & Bittmann, S. (2013). Reminder: How with little effort the vaccination of children can be made less painful. Clinical Pediatrics, 52, 765–766. Wong, D., & Baker, C. (1988). Pain in children: Comparison of assessment scales. Pediatric Nursing, 14, 9–17.
Quality Improvement Project to Reduce Pain and Distress Associated With Immunization Visits in Pediatric Primary Care1,2 Stephanie Burgess, DNP ⁎, Donna G. Nativio, PhD, CRNP, FAAN, Joyce E. Penrose, DrPH, CRNP, FNP-BC University of Pittsburgh School of Nursing, Pittsburgh, PA Received 10 May 2014; revised 2 September 2014; accepted 5 September 2014
Key words: Distraction; Immunization; Anesthetic spray
This quality improvement project implemented an evidence-based immunization protocol aimed at decreasing pain and distress associated with immunizations for children ages 4 to 6 by utilizing distraction and a benzocaine-based anesthetic spray. The original protocol is used at a large, universitybased pediatric primary care hospital. A convenience sample of 30 children from a community-based healthcare center was utilized to assess effectiveness in alternate settings. This quasi-experimental project collected survey information from child participants and consenting caregivers. Statistical analysis by paired t-test indicated a statistically significant decrease in reported distress by both the child and the caregiver utilizing the immunization protocol. © 2015 Elsevier Inc. All rights reserved.
Background Under immunization of children has become more prominent in the United States as more parents are following alternative vaccination schedules or refusing vaccinations all together. Evidence has linked vaccine refusal with outbreaks of vaccine preventable diseases (Omer, Salmon, Orenstein, deHart, & Halsey, 2009). A study by Atwell et al. (2013), further suggests clusters of unvaccinated individuals “may have been 1 of several factors in the 2010 California pertussis resurgence” (p. 624). The Centers for Disease Control and Prevention currently recommends children to be vaccinated against sixteen different illnesses. Most vaccinations are 1
No extramural funding or commercial financial support has been utilized in this study. 2 The paper has not previously been presented. ⁎ Corresponding author: Stephanie Burgess, DNP. E-mail addresses: [email protected] http://dx.doi.org/10.1016/j.pedn.2014.09.002 0882-5963/© 2015 Elsevier Inc. All rights reserved.
given as multi-dose series resulting in as many as 33 injections by age 6 years (CDC, 2014). The immunization protocol utilized by a primary care office can greatly impact the overall immunization experience. Stockwell, Irigoyen, Martinez, and Findley (2011) discovered an association between previous negative immunization experiences and under immunization in children. These findings imply that childhood experiences with immunizations have the potential to impact the incidence of vaccine preventable diseases. Therefore, steps should be taken to decrease painful and distressing immunization experiences to increase on-time vaccination. Furthermore, a “reduction in perceived pain or anxiety by the parent may promote timely return for future vaccinations” (Luthy, Beckstrand, & Pulsipher, 2013, p. 352). Stress reduction is a common technique utilized during painful and distressing situations. In existing studies comparing stress reduction techniques, distraction appears to be a method of choice for pediatric patients. Providing appropriate distraction creates the potential to reduce the
TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATION overall distress exhibited by the patients as well as their caregiver (Manne, Redd, Jacobsen, Gorfinkle, & Schorr, 1990). Manne et al. (1990) used party blowers as a means of distraction in children aged 3 to 9 years undergoing venipuncture while other studies have used touch screen electronic toys and virtual reality glasses. Reis and Holubkov (1997) studied the utilization of a.) distraction alone versus b.) distraction combined with a vapocoolant spray and c.) distraction combined with an eutectic mixture of local anesthetics (EMLA) cream during immunization procedures. Their findings indicate that using a method of distraction combined with the use of a vapocoolant spray is an effective, fast and inexpensive way to reduce the pain and distress associated with immunizations. Immunizations are a recommended and beneficial procedure. Rarely are steps taken to decrease the associated pain and distress despite available evidence-based protocols due to time constraints (Weissenstein, Straeter, Villalon, Luchter, & Bittmann, 2013). Pain and distress are known barriers to meeting recommended immunization rates. The health care center where this project was implemented had not been using a standard protocol for immunizations aimed at decreasing pain and distress. To help lessen those aforementioned barriers to meeting recommended immunization rates, an evidence-based immunization protocol developed for and still in use at a large, university based pediatric primary care hospital was utilized. The goal of this project was to decrease pain and distress for both the patient and the accompanying caregiver by implementing an immunization protocol utilizing an active physical distracter and a benzocaine-based anesthetic spray with immunizations visits in an urban, community-based, primary care center.
295
Staff Education To educate the staff in preparation for participating in this project, a lecture focusing on the importance of pain and distress reduction to aid immunization compliance and timeliness was provided to the two registered nurses, a nurse practitioner and a medical assistant. The project protocol was described, and the staff's role and participation was discussed. They were allowed to practice with the materials, and their questions were addressed.
Intervention
This quality improvement project, guided by the Reis and Holubkov (1997) study findings, was completed in a small, urban, community-based health care center situated in a medically underserved neighborhood. The majority of patients have government funded insurance and benefit from the Vaccines for Children program where they receive vaccines at no cost. The pediatrician in the center has been serving this community for nearly 25 years, the nurse practitioner and medical assistant have been there 1 year and the registered nurses have each provided 2 years of service.
All children aged 4 to 6 years, receiving at least one immunization were eligible to participate unless there was a known sensitivity to benzocaine. Once a patient in the appropriate age range was identified on the schedule, a chart review was completed, prior to their scheduled appointment, to identify any known allergy or sensitivity to benzocaine. The patient/caregiver dyads were approached in their exam room after their immunizations were ordered by the MD or NP to assess their willingness and ability to participate in the project. A script was utilized to explain the project to the dyad. If they agreed to participate, a consent form, written at a fifth grade reading level, was signed and kept on file. A copy was provided to the signer. After consent was gained, the dyad was instructed on how to fill out the short pre-immunization survey consisting of three questions which were read to the caregiver by the first author (see Box A). Before immunization, all children, were provided with a party blower as a distraction and instructed to blow it at the RN's, MA's or caregiver's moving hand, as if it were a target, during the procedure. Practice blowing was encouraged prior to the immunization. The staff administering the injection sprayed the injection site with the benzocaine-based cooling spray for 5 to 10 seconds at least 3 inches away from the skin, waited 20 to 30 seconds, cleaned the site with alcohol and administered the injection per manufacturer's recommended route while facilitating the party blower use. Following immunization, the caregiver completed the postimmunization survey consisting of three questions, nearly identical to the pretest, which were also read to the caregiver (see Box B). A cover sheet identifying the child's age, sex, reason for visit, accompanying caregiver, additional members in the room, immunization(s) received and who administered the immunization was completed, and all data forms were placed in a manila envelope to promote organization and confidentiality and were kept in a locked file box to await analysis.
Human Subject Protection
Data Collection
The University of Pittsburgh Institutional Review Board considered this project to be exempt. Written consent was obtained from the caregivers of the participating patients.
Prior to immunization, the first author collected historical data from the accompanying caregiver utilizing Visual Analog Scales (VASs). These scales have been found to be
Methods Setting
296
S. Burgess et al.
Pre-Immunization Ratings 1.) Please mark a line to indicate how upset your child was after the last immunization they received.
Not At All Upset
Extremely Upset
2.) Please mark a line to indicate how upset you were after the last immunization your child received.
Not At All Upset
Extremely Upset
3.) Please help your child circle the face which best shows how they are currently feeling.
Box A
Pre-immunization ratings.
reliable tools to assign number values to typically subjective data such as pain and distress with an intraclass correlation coefficient of 0.97 [95% CI = 0.96 to 0.98] (Bijur, Silver, & Gallagher, 2001). VASs are horizontal lines exactly 100 mm in length with a descriptor phrase on each end of the line. The descriptors are typically opposite ends of a spectrum such as “not at all upset” and “extremely upset” and, therefore, create a continuum of possible answers. The individual being assessed marks a vertical line somewhere on the continuum of the VAS which they feel best describes how they feel. This mark is then measured, in mm, from the left margin, to numerically describe their answer. The caregivers were asked to identify the typical level of distress expressed by the child as well as the typical level of distress they experience as the observing caregiver by marking a line on sliding scale labeled with descriptors from “not at all upset” to “extremely upset”. Following immunization, utilizing a VAS with the aforementioned sliding scale, the caregiver was asked to identify the level of distress expressed by the child as well as the level of distress they experienced during the current immunization. Additionally, pre- and post-immunization data on pain were collected by the first author directly from the child utilizing the Wong-Baker FACES Pain Rating Scale to
quantify any change in pain rating associated with the immunization procedure. The Wong-Baker FACES Pain Rating Scale is a widely utilized measurement tool which allows children to effectively describe the pain they are feeling. This scale has been found to be both reliable, with a statistically significant test–retest reliability of r = .83, and valid, with a statistically significant concurrent validity when compared to both a word graphic scale (r = .63) and a numerical scale (r = .75), for the age range being assessed in the project (Keck, Gerkensmeyer, Joyce, & Schade, 1996). Furthermore, in a study by Wong and Baker (1988) comparing six separate pain assessment scales, the FACES Pain Rating Scale scored the highest preference in children ages 3 to 7 years. The scale consists of a series of six faces with increasing levels of discomfort displayed on them. A child is to select the face which best illustrates how they feel. Each face has an associated number which allows their pain to be numerically described. A cover sheet identifying the child's age, sex, reason for visit, accompanying caregiver, additional members in the room, immunization(s) received and who administered the immunization was completed by the first author. Following the completion of data collection, the RNs and MA participating in the administration of immunizations
TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATION
297
Post-Immunization Ratings 1.) Please mark a line to indicate how upset your child was after today’s immunizations.
Not At All Upset
Extremely Upset
2.) Please mark a line to indicate how upset you were after your child’s immunizations today.
Not At All Upset
Extremely Upset
3.) Please help your child circle the face which best shows how they are currently feeling.
Box B
Post-immunization ratings.
were given a Likert scale survey to assess the feasibility of the protocol which was created by the first author (see Box C). On this Likert scale, the answer choices ranged from “1: strongly disagree” to “5: strongly agree”. They were asked to respond to the following statements, a.) “Our current method of immunization for children, ages 4 to 6, works well in our setting.” b.) “I am willing to try another method to improve the outcome for the child and caregiver.” c.) “A method of immunization using distraction and a benzocaine-based vapocoolant spray has the potential to improve our immunization procedure.” d.) “I am likely to continue to use an immunization procedure using distraction and benzocaine-based vapocoolant spray in the future.” and e.) “I think it is realistic to continue to use this immunization procedure in our setting.”
Data Analysis Data were analyzed utilizing SPSS version 19. The preand post-immunization data from the VAS and the WongBaker FACES Pain Rating Scale underwent paired t-test analysis. The feasibility data from the staff was analyzed for measures of central tendency.
Results Recruitment took place from September to mid-October 2013. During that time, a total of 30 dyads were approached for involvement in this project, and all 30 agreed to participate. They are described in Table 1. Of the 30 participants, 50% were age 4, 26.6% were age 5 and 23.3% were age 6. With 12 males and 18 females, the majority were present with their mother (80%) while others presented with their father (6.6%), grandmother (6.6%), mother & father (3.3%), and foster mother (3.3%). Eighteen presented for an annual well child visit, 7 for an acute visit, and 5 for other visits. As for the number of vaccinations received, 60% received a single vaccination, 10% received two, 3.3% received three, 20% received four, and 6.6% received five vaccinations. There were no additional family members in the room for 40% of the dyads, another 40% had one additional family member, 16.6% had two additional family members and 3.3% had three additional family members in the room. Table 2 summarizes the pre- and post-intervention data for all participating dyads. Age, sex and number of
298
S. Burgess et al. 1.) Our current method of immunization for children, ages 4 to 6, works well in our setting. 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
2.) I am willing to try another method to improve the outcome for the child and caregiver. 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
3.) A method of immunization using distraction and a benzocaine-based vapocoolant spray has the potential to improve our immunization procedure. 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
4.) I am likely to continue to use an immunization procedure using distraction and benzocaine-based vapocoolant spray in the future. 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
5.) I think it is realistic to continue to use this immunization procedure in our setting. 1 Strongly Disagree
2 Disagree
3 Neutral
Box C
Demographics. n (%)
Age
Sex Accompanying caregiver
Type of visit
Vaccinations received
Additional family members in room
4 5 6 Male Female Mother Father Grandmother Mother & father Foster mother Annual well child Acute visit Other 1 2 3 4 5 0 1 2 3
15 8 7 12 18 24 2 2 1 1 18 7 5 18 3 1 6 2 12 12 5 1
(50) (26.7) (23.3) (40) (60) (80) (6.7) (6.7) (3.3) (3.3) (60) (23.3) (16.7) (60) (10) (3.3) (20) (6.7) (40) (40) (16.7) (3.3)
5 Strongly Agree
Feasibility survey.
immunizations have also been listed in the table to aid in comparison. The staff participating in the administration of the immunizations were given the five question Likert scale feasibility survey previously described. The findings are summarized in Table 3. For the first question, “Our current method of immunization for children, ages 4 to 6, works well
Table 1
4 Agree
in our setting.”, the average response was 3.67. The second question, “I am willing to try another method to improve the outcome for the child and caregiver.”, had an average response of 4. The third question, “A method of immunization using distraction and a benzocaine-based vapocoolant spray has the potential to improve our immunization procedure.”, had an average response of 4.67 while the fourth question, “I am likely to continue to use an immunization procedure using distraction and benzocainebased vapocoolant spray in the future.”, had an average response of 4.67. Finally, for the fifth question, “I think it is realistic to continue to use this immunization procedure in our setting.”, the average response was 4.67. The paired-t test analysis of the pre- and post-intervention child distress ratings produced a t = 2.985 with a 2-tailed significance of p = .006 (Table 4). This indicates a statistically significant decrease in the child's reported distress following an immunization procedure which utilized distraction and a benzocaine-based anesthetic spray as compared to an immunization procedure which did not utilize distraction and a benzocaine-based anesthetic spray. The paired-t test analysis of the pre- and post-intervention caregiver distress ratings produces a t = 3.226 with a 2-tailed significance of p = .003. This also indicates a statistically significant decrease in the caregiver's reported distress following an immunization procedure which utilized distraction and a benzocaine-based anesthetic spray as compared to an immunization procedure which did not utilize distraction and a benzocaine-based anesthetic spray. For the paired-t test analysis of the pre- and postintervention pain ratings, a t = − .348 with a 2-tailed significance of p = .730 was found. This indicates that there was not a statistically significant increase in the
TO REDUCE PAIN AND DISTRESS ASSOCIATED WITH IMMUNIZATION Table 2
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Mean
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Pre- and post-intervention data. Age Sex Number of Caregiver's estimation of immunizations child's response received Pre-intervention Post-intervention distress rating distress rating
Caregiver's response
5 5 4 4 4 4 4 6 5 4 5 5 6 4 4 5 4 6 6 4 4 4 4 4 4 6 6 5 6 5
4 9 82 84 78 20 60 14 12 67 0 0 55 6 87 0 79 64 0 100 32 0 50 100 79 9 9 5 51 0 38.53
F F M F F M F M M M M M F F F F F F M F M M M F F F F M F F
4 1 1 1 1 4 4 1 1 4 1 1 1 5 4 1 2 1 1 1 5 2 2 4 3 1 1 1 1 1
55 53 57 73 36 100 21 12 10 40 52 100 25 68 70 43 79 78 0 0 29 0 52 100 100 8 8 79 100 45 49.77
24 7 5 18 10 51 11 8 9 97 0 0 38 92 94 0 90 66 0 0 35 16 26 54 75 12 15 38 74 0 32.17
reported level of pain for the child before the immunization procedure as compared to the reported level of pain after the procedure. Table 3
Feasibility survey responses.
Question
Average response
Our current method of immunization for children, ages 4 to 6, works well in our setting. I am willing to try another method to improve the outcome for the child and caregiver. A method of immunization using distraction and a benzocaine-based vapocoolant spray has the potential to improve our immunization procedure. I am likely to continue to use an immunization procedure using distraction and benzocaine-based vapocoolant spray in the future. I think it is realistic to continue to use this immunization procedure in our setting.
3.67 4
Pre-intervention Post-intervention Pre- intervention Post-intervention distress rating distress rating pain rating pain rating 2 2 9 7 17 0 8 13 12 87 0 0 43 6 94 0 44 50 0 55 20 0 30 31 79 13 14 3 50 0 22.97
4.67
6 0 0 0 0 2 2 4 0 8 0 8 8 2 0 0 0 2 2 0 0 0 8 0 10 4 2 4 0 2 2.47
0 0 0 0 0 6 0 0 0 10 0 2 10 6 8 0 6 4 0 2 4 2 6 4 0 0 0 2 10 0 2.73
The nursing staff indicated that they are likely to continue to use the immunization procedure with distraction and a benzocaine-based anesthetic spray. Furthermore, they also believe that is it strongly realistic and feasible to do so in their setting.
Table 4 Paired-t test data comparing pre- and post-intervention data. t
4.67
4.67
Child's pain rating
df Significance (2-tailed)
Pre- vs. post-intervention child 2.985 29 .006 ⁎ distress rating Pre- vs. post-intervention caregiver 3.226 29 .003 ⁎ distress rating Pre- vs. post-intervention pain rating − .348 29 .730 ⁎ = Significant at p b 0.05.
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Discussion While there was no statistically significant change in pain rating, this is a clinically significant finding. Minimizing the amount of pain inflicted with immunizations, which are typically a painful, tearful experience, is an asset for this protocol. This finding coupled with the statistically significant decrease in distress supports the utilization of this evidencebased immunization protocol to promote a limitation of pain and a decrease in distress associated with immunizations for this setting. All staff participating in this project supports this protocol, and the patient population appears to support this protocol as well as all dyads approached for participation in this project agreed to participate. The protocol is not time consuming and is easily integrated into the staff's immunization process. As found in previous studies, distraction and, specifically, party blowers work well as a method of limiting pain and distress associated with painful procedures in those aged 4 to 6 years. Furthermore, despite using an alternative spray, this project supports Reis and Holubkov (1997)'s findings which indicate using a method of distraction combined with the use of a vapocoolant spray is an effective, fast and inexpensive way to reduce the pain and distress associated with immunizations. While the findings from this project could be attributed to the novelty of the party blower and anesthetic spray, only further study would be able to ascertain this.
Conclusions Finding an immunization procedure that not only garners staff buy-in but also produces statistically significant less distress for both the child and the caregiver is a positive step toward promoting on-time immunization. If used consistently and properly, this immunization procedure has the potential to decrease negative immunization experiences, increase on-time immunization and decrease the incidence of vaccine preventable diseases. If the health care center where this project was conducted adopts this protocol as their standard procedure, periodic monitoring will need to be conducted to ensure that the
S. Burgess et al. protocol is being utilized correctly. It will also need to be adopted into the new staff orientation process. In the future, further study could evaluate the effectiveness of the protocol outside of the 4 to 6 year age range. It may be beneficial to the overall protocol to have options of physical distractors for the child or caregiver to select which they like best. This may improve the impact of the distractor and allow caregivers to select a method which is appropriate for their child. Furthermore, it may prove beneficial to conduct additional studies to identify any significant impact that the number of immunizations and even the number of individuals in the room may have on the child's level of pain and distress.
References Atwell, J. E., Otterloo, J. V., Zipprich, J., Winter, K., Harriman, K., Salmon, D. A., et al. (2013). Nonmedical vaccine exemptions and pertussis in California, 2010. Pediatrics, 132, 624–630. Bijur, P. E., Silver, W., & Gallagher, J. (2001). Reliability of the visual analog scale for measurement of acute pain. Academic Emergency Medicine, 8, 1153–1157. Centers for Disease Control and Prevention (2014). Birth – 18 years & “catch-up” immunization schedules. Retrieved from. http://www.cdc. gov/vaccines/schedules/hcp/child-adolescent.html. Keck, J., Gerkensmeyer, J., Joyce, B., & Schade, J. (1996). Reliability and validity of the faces and word descriptor scales to measure procedural pain. Journal of Pediatric Nursing, 11, 368–374. Luthy, K. E., Beckstrand, R. L., & Pulsipher, A. (2013). Evaluation of methods to relieve parental perceptions of vaccine-associated pain and anxiety in children: A pilot study. Journal of Pediatric Health Care, 27, 351–358. Manne, S., Redd, W., Jacobsen, P., Gorfinkle, K., & Schorr, O. (1990). Behavioral intervention to reduce child and parent distress during venipunture. Journal of Consulting and Clinical Psychology, 58, 565–572. Omer, S., Salmon, D., Orenstein, W., deHart, P., & Halsey, N. (2009). Vaccine refusal, mandatory immunization, and the risks of vaccine-preventable diseases. New England Journal of Medicine, 360, 1981–1988. Reis, E., & Holubkov, R. (1997). Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics, 100, e5. Stockwell, M., Irigoyen, M., Martinez, R., & Findley, S. (2011). How parents’ negative experiences at immunization visits affect child immunization status in a community in New York City. Public Health Reports, 126, 24–32. Weissenstein, A., Straeter, A., Villalon, G., Luchter, E., & Bittmann, S. (2013). Reminder: How with little effort the vaccination of children can be made less painful. Clinical Pediatrics, 52, 765–766. Wong, D., & Baker, C. (1988). Pain in children: Comparison of assessment scales. Pediatric Nursing, 14, 9–17.
