Journal Nursing of Pediatric

Journal of Pediatric Nursing 38 (2018) 1–7Contents lists available at ScienceDirect Journal of Pediatric Nursing Effects of Thermomechanical Stimulation during Vaccination on Anxiety, Pain, and Satisfaction in Pediatric Patients: A Randomized Controlled Trial1,2 Roberta E. Redfern, PhD a, John T. Chen, PhD b, Stephanie Sibrel, BSN, RN c,⁎ a Research, ProMedica Toledo Hospital, Toledo, OH, United States b Department of Mathematics and Statistics, Bowling Green State University, Bowling Green, OH, United States c Northwest Ohio Hemophilia Treatment Center, ProMedica Toledo Children's Hospital, Toledo, OH, United States a r t i c l e i n f o a b s t r a c t Article history: Purpose: Vaccination can be a significant source of pain for pediatric patients, which could result in fear of medical Received 4 April 2017 procedures and future reluctance to seek medical care. It is important for nurses to provide pain prevention dur- Revised 20 September 2017 ing these procedures. This study sought to measure the impact of an intervention combining cold and vibration Accepted 20 September 2017 on pain scores during routine pediatric immunization. Available online xxxx Design and Methods: A prospective, open-label, randomized controlled trial to examine the effectiveness of the Buzzy device (thermomechanical stimulation) compared to no intervention (control group) in reducing child- Keywords: Pain reported pain during routine immunization. The Wong Baker Faces scale was used to collect child, parent, and Vaccine injection observer reported anxiety and pain. Parents reported satisfaction with the procedure and overall office visit. Satisfaction Results: Fifty children between the ages of 3 and 18 were included in the present analysis. Mean child-reported Distraction pain scores were significantly lower in the group receiving thermomechanical stimulation compared to control Anxiety (3.56 vs 5.92, p = 0.015). Buzzy did not impact child-reported anxiety or how much pain the child expected. Buzzy Parent-reported satisfaction did not vary significantly between groups, but was strongly associated with parent-reported pain scores. Conclusions: Thermomechanical stimulation with the Buzzy device significantly reduced pain during pediatric immunization over a wide range of ages compared to control, but did not impact pre-procedure anxiety. Practice Implications: The Buzzy device is an easy to implement intervention to reduce pediatric pain during vac- cination. It may have the greatest impact in younger children but could be offered during all immunizations. © 2017 Published by Elsevier Inc. Introduction of vasovagal reflexes, the remaining 30% are considered classic phobias arising due to traumatic experiences, particularly during pediatric Procedures that require a needle stick are among the most common venipunctures in which the patient perceives that medical personnel procedures for pediatric patients in the health care setting and are a completed procedures without any effort to relieve pain or anxiety source of pain (Cummings, Reid, Finley, McGrath, & Ritchie, 1996; Inal (Lynn, 2010). Fear or anxiety associated with needle procedures does & Kelleci, 2012a). Routine vaccination has been suggested to be the not always resolve with time or age, and may result in delays in care most common cause of iatrogenic pain during childhood (Taddio et al., or avoidance of treatment in both pediatric and adult patients (Taddio 2009). The pain that accompanies these procedures may induce anxiety et al., 2010). Specifically, the success of immunization programs has in both pediatric and adult patients, with significant consequences. Nee- been suggested to be impacted in part due to fear-induced non- dle phobia is estimated to affect approximately 10%–20% of the popula- compliance. Managing the emotional and physical effects of needle pro- tion (Hamilton, 1995; Taddio et al., 2012). While it is believed that a cedures has become an important part of nursing practice, and inter- majority of needle phobia is due to genetic factors and the experience ventions to prevent pain during vaccination have been advocated (Rogers & Ostrow, 2004; Taddio et al., 2012). Many types of interventions have been studied with the goal of re- 1 No funding was received for the support and conduct of this research project. ducing pediatric pain during venipuncture including pharmacologic 2 The authors have no relevant financial disclosures or conflicts of interest to report. ⁎ Corresponding author at: Center for Health Services, 2150 W Central Ave, Suite K, (EMLA cream), behavioral distractions (music, video games, kaleido- Toledo, OH 43606, United States. scopes), tactile interventions (stroking, ShotBlocker), sweet solutions E-mail address: [email protected] (S. Sibrel). for infants (glucose or sucrose), and cold analgesia (vapocoolant https://doi.org/10.1016/j.pedn.2017.09.009 0882-5963/© 2017 Published by Elsevier Inc. This study aimed cian offices... search staff were blinded to the group assignment. and opened at the time of consent. Benjamin et al. Kozman. as previously described (Inal & Kelleci. Shahine. Atlanta.5 and 4. campus of ProMedica Toledo Children's Hospital and ProMedica Toledo nificant pain reduction was achieved per child self-report and observer Hospital.000 annual admissions. 2017). icance level of 0. Buzzy is thought to provide pain relief via gate control theory. Board reviewed and approved this study prior to commencement. ents or legal guardians provided written informed consent for all partic- Kunselman. 1984). cally significant difference in child-reported pain was calculated prior to In 1984. sealed envelopes The Buzzy device. A randomization schedule was created by research staff of those investigated. studies investigating the present (per manufacturer's recommendation). & Schwartz.E. 2015). group. & Sevim Akbay. Verbal assent was gained from children who were 3–6 years of ed that Buzzy significantly reduced pain during venipuncture in pediat. massage.. Inal. Similarly. enrollment. Assuming mean pain scores 3. Lawson. using www. The number of injections required during the however the majority of these studies completed in pediatric popula. & von Baeyer. motor resembling a bee or ladybug that combines cold and vibration iety in these patients and whether use of the device affects parent satis. all ages would be eligible to be included. Similarly. Ohanian. 2004). Leong. or if they had been previously ex- Most reports of the device suggest it provides significant pain relief. Participants were excluded if Reynaud's greater pain relief using Buzzy compared to vapocoolant sprays syndrome or sickle cell disease with extreme sensitivity to cold was (Baxter. Inal & Kelleci. McElvery. age and written assent was obtained from all children who were ric patients with cognitive impairment as well (Schreiber et al. Bini et al. While these studies have given some evidence of the device's efficacy. Hagbarth. same. ipants. 2014). Redfern et al. This open label randomized clinical trial was conducted at tematic review of interventions suggested that vapocoolant sprays are ProMedica Toledo Hospital's Center for Health Services from April not effective in preventing vaccination pain in children. and 7% Hispanic or Latino. / Journal of Pediatric Nursing 38 (2018) 1–7 sprays). to determine whether Buzzy is effective over a range of vaccine injec. 2015).. Schady. GA) is a reusable.0 ± 2. Cruccu. 2016). with varying results. however 2016 through September 2016 and assessed the efficacy of Buzzy during EMLA creams were successful when compared with control (Shah a vaccine injection. a sys. 27% Objective African American. Fewer studies have focused on the impact Methods of intervention on immunization pain in pediatric populations. abrasion on the skin where the device would be placed. re- faction compared to those receiving standard of care using 1–10 Likert usable ice packs were used and were solidly frozen prior to every appli- scale questions as well as a categorical rating of better. children. allocation were placed into sequentially numbered. Pilot data in adults demonstrated well visit and were Buzzy naïve. a medical office building on the both cold and vibration during DTaP vaccine injection indicated that sig. 1965). 2017. one can also close the fast pain gate via presynaptic inhibition Children who were at least 3 through 18 years of age were eligible to at the dorsal horn. The surrounding area is urban. analge- 2011). diagnostic testing. The device can be secured to the patient with the use of an than expected rating for overall experience. & Badr. Hockenberry-Eaton. Moore. ProMedica Toledo Hospital is a 794-bed tertiary care center with over tions and child ages. neurodevelopmental delays or verbal difficulties were present. Thomas. A recent study report. few have focused on thermomechanical stimulation during pediatric Setting immunization. accredited by The Joint Commission and lo- cated in Toledo.randomizer. The experimental device evaluated in this study was applied to pa- Wilson. it was determined that 50 patients were needed per tion. 30.0 the ex- search group induced pain in healthy research subjects using electrical perimental and control groups in order to achieve 80% power at a signif- stimulation in order to test whether common maneuvers such as vibra. of which approximately 65% are Caucasian. combines multi. the combination of the two would provide optimal participate if undergoing routine vaccination injection at their annual pain relief (Melzack & Wall. nor re- ple approaches by supplying cold analgesia.000 residents. 7 years of age and older. Participants esized that by simultaneously stimulating Aβ mechanoreceptors with vibration. The necessary sample size to demonstrate a statisti- et al. nerve damage rior pain relief in children while confirming the feasibility of its use in a was present which would affect the extremity being injected. a vibrating motor with ice pack. or cooling would affect subjects' pain experi. The center includes multiple primary care and specialty physi- scores (Canbulat Sahiner. 2012b. 2016). Neither parents. 2012b. Winkelstein. and dis. at times completely inhibiting moderate pain. sia had been used within the past 6 h. However. Vibration Preliminary analyses were planned in order to allow for early termina- provided the most effective response on its own. with about 280. OH. Folded paper tags with group not been used in conjunction in a clinical setting until recently. The effects of EMLA and vapocoolant spray were studied in infants using Design duration of cry as a measure of pain with no impact compared to breastfeeding during vaccination (Gupta et al. 2009). & Woody. and behavioral health services. reported that vibration therapy alone (without cold analgesia) was not effective in reducing immunization Subjects were enrolled within a single pediatric primary care office pain (Benjamin. adjustable tourniquet or by pressing and holding the device in place . In this study. 2016. 2001) during routine vaccination in. & Mathew. ence (Bini.05. 2011. to either receive the Buzzy intervention or standard of care (no pain- tion were combined (thermomechanical stimulation). Whelan. Julious. a combina. reported an interesting phenomenon: the re.org in advance of recruitment to assign patients Though impressive pain reduction was observed when cold and vibra. by stimulating nerves with cold to “close” the fast pain gate. however. It is hypoth.2 R. tients randomized to the experimental group. posed to the Buzzy device. traction. The Buzzy device (MMJ jections at well visits in a pediatric population. warming. there was a break or use of this device in pediatric populations have also demonstrated supe. Par- Moadad. fast-paced care setting (Baxter. visit was not a factor in patient inclusion or exclusion so that children of tions focused on children undergoing venous cannulation or venous ac. Cohen. & Tamburro. the two have reducing intervention) during injection. Hendrix. The main objective of this study was to determine whether the Test Device Buzzy thermomechanical system reduced procedural pain as measured by the Wong Baker Faces Pain Scale (Wong. a recent study of of this urban community care center. tion if significance was reached at the halfway point of recruitment for tion of vibration and cooling provided the most potent analgesic effect this project.0 ± 1. or worse cation. tactile stimulation. The local Institutional Review cess for blood draws (Baxter et al. using a thin (disposable or reusable) ice pack (wings). battery-operated plastic vibrating included the evaluation of whether Buzzy affected pre-procedural anx. & Torebjork. The secondary objectives Labs. Instruments used to measure anxiety and pain. & Schade. the device was held di. how scared they were about the needle stick using this scale. The parent was asked to independently cannulation or access for blood draw. and an independent observer also rated the Children randomized to the control group were provided no interven. Because parents and children were not in separate from soothing children. ately following consent. and location of injections during the visit. R. 15 min test-retest reliability has been reported parent. using tical analysis. but were not used in this study. a the site immediately prior to injection. Distraction cards are available rate how scared or anxious they felt their child was about the injection for use in conjunction with the device. Four nurses flipped over after rating). This was done for consistency and ease of rating for younger tion is not a concern during injection as it could be during venous children involved in the study. children were asked to rate ings of post-procedural pain. (Fig. 2001). before the child rated it. Parents also report. which was discussed with parents immedi- who were not part of the research team delivered the injections. Immediately following the injection.. The association of 3 years of age and older. 2001). Gerkensmeyer. the child was then asked to rate how much chose. parents were not restricted modified scale. This is due in part to the fact that vasoconstric. jections. 2003. and observer ratings as well as the association of pain rat- to be high with r = 0.2 (SAS Institute Inc.E. moved 3 to 5 cm proximal to modified to 6 categories matching the face: not scared. Redfern et al. when a needle stick is required. The demographic form leaving the office. 1). researchers asked each participant to rate how much they thought SAS version 9. Descriptive statistics detailed patient characteristics upon the Wong Baker Faces Pain Scale (Wong et al. ents were asked to complete a brief satisfaction questionnaire before ground information prior to the needle stick. Per the manufacturer's instructions. USA) was used for statis- the needle stick was going to hurt prior to the vaccine injection. Because the explanation of the device during the consent process Data Analysis could affect the child's expectation of and subsequent perception of pain. however. Research staff recorded the child's would prefer for their child to receive the Buzzy device in the future BMI as assessed by clinical staff during the well visit. age. Luffy & Grove. really scared. Parents stayed in the sponses (moved to opposite ends of room. rience was the same. .. child. and held in place during the en. or worse than expected. They were also asked to rate whether the expe- of needle sticks than other children of the same age. both using this tion or distraction during injection. the parent and observer rated The device was shown to parents and children prior to enrollment. serving as the observer Procedure and Instruments and collecting pre.93 (Keck. Wong et al. 1996.90 and Cronbach's α = 0. This was an unvalidated questionnaire developed by asked how many vaccinations their child had experienced in the past. Missing data was imputed using Markov Fig. parents were asked to complete a the injection hurt using the Wong Baker Faces Pain scale. Wong Baker Faces Pain Scale (top) and modification for anxiety measurement (bottom). and gender of the child. Small children were allowed to sit on a parent's rooms. papers were folded and/or room with all children during the entirety of the procedure. NC. Finally. One of five mem- bers of the research team recruited each patient.. when forms were distributed. however. Upon provision of consent. no active distraction was provided. In addition. ings with satisfaction ratings were completed using Pearson correlation Joyce. better. which was rectly over the site of injection for 30 s. the child's reaction and experience of pain independently of one anoth- and children were allowed to touch and turn on the device if they er prior to the child's rating. and whether they ed race. Cary. respectively. child's pre-procedural anxiety before the child rated it. valid pain scale. Children coefficient analysis. and whether the parent believed that the child was more fearful from poor to excellent. all attempts were made to blind each rater to one another's re- lap. par- brief demographic form developed by the authors to provide back.and post-test data. Chi squared and Student t-tests were used to investigate Faces Pain Scale has been shown to be valid and reliable in children categorical and continuous variables. and most scared tirety of the needle stick. little more scared: even more scared. The Wong Baker study entry. the number of in. / Journal of Pediatric Nursing 38 (2018) 1–7 3 manually. Parents were asked to rate their child's overall experience whether they had ever exhibited a vasovagal response to a needle and their experience specifically with the injection on a ten point scale stick. 1. a little scared. the authors. Post-hoc ordinal variable regression was performed under 3 years of age were not eligible for inclusion in order to allow for to examine the significance of potential factors affecting children's rat- use of a single. Characteristic Buzzy N Control N t p-Value Results Age 10. .36).015. p = 0.85 BMIa 23. gender. (R = 0. parent.7 25 0. High school and below 12 15 0 1.53. which were not statistically different from one anoth. parent characteristics. the association between child. in comparing the Two or more 16 9 post-procedure pain ratings given by children.51 Caucasian 10 6 between groups. comparing ratings of post-procedure pain.8 24 33.7 ± 4.43).2 0.39 (95% CI −0.34.5 22 1.001.1) and those receiving more than one injec. group reported significantly lower pain than those in the control group. High school and below 14 10 2. / Journal of Pediatric Nursing 38 (2018) 1–7 Chain Monte Carlo method with multiple imputations.2 ± 6. the means did not differ significantly between control One 9 16 3.4 R. No characteristic of interest varied significantly African American 12 14 2. The Female 15 17 0.49 vs 0.6 24 0.09 0.30 Demographics Mother's age 33.21 0.8).2 ± 3. Participant flow and allocation.7 21 0.72 ± 3. Table 3).56 mean age of the Buzzy group was 10. Neither parents nor observers rated patients in the with child ratings (Table 3).1 17 35. Mean pain reported between those receiv. Investigation into statistically different on Student t-test (p = 0.7 ± 7. This effect was also present Parent and observer ratings compared by t-test echoed the results of in the comparison of association between observer ratings of anxiety the child ratings.68 ± 7. Table 1).5 ± 4.4 24 5. with a mean difference of −2.00 ± 3.53.85.7 ± 4. without considering group assignment. In that BMI and age may each be independently related to child-reported Fig.24.E. The only variable that differed be. One child was consented Gender and withdrawn after randomization to the Buzzy group due to age.92 0.047 and Buzzy group (5.18 vs 4.05 0.3 ± 3. and Mixed race 3 4 number of previous needle sticks.30 0.86 0. and observer ratings revealed paring how much the children thought the injection would hurt. but not significantly tion (5. those in the Buzzy a Calculated from current well visit height and weight measurements.7 25 10.9 ± 8. the Buzzy group was rated ing one injection (4. in com.5 ± 4.2 22 −0. including BMI.05 in advance of recruitment. 2. Table 2).8 20 21. though only slightly group was 5.72 compared to 5.15 tions at the current visit was significantly higher than in the control Above high school 9 15 Education of dad group.5 ± 8. t = −2.45.84 Child's expected pain 5.7 compared to 10.26 0. Self-reported patient7 characteristics on study entry. Significance Table 1 level was set at p b 0.0 Above high school 4 5 Anxiety and Pain Previous needle procedures b4 15 18 1.04).17 4 and above 10 5 The anxiety ratings by children in both groups were compared by Number of injections Student t-test.7 in Male 10 8 the control group.0 in the Buzzy group (p = 0. wherein the proportion of Education of mom patients randomized to the Buzzy group receiving two or more injec.22 Fifty-one children undergoing routine vaccination consented to par- ticipation in the study. Table 2). Buzzy that observer-rated pain score was more closely related to child- did not impact children's expectations as the mean rating in the control reported pain score than were parent scores.35 0.76 0. p = 0. Pearson correlation tests also suggested Buzzy group to be less anxious than in the control group (Table 2). Hispanic 0 1 tween groups was the number of injections. 2). However. There were no adverse events in either group.48 to −4. Furthermore. Redfern et al. lower than the control by the observers (p = 0. Race er (p = 0.09) compared to the control group. 26 were randomized to the Buzzy group and 25 Buzzy Control Chi-square p-Value to the control (no intervention) group (Fig. both p b 0.80 Father's age 36.2 ± 7. was not by parents (p = 0. only the vibrating ed (Table 4). when taken together.12 Probably not 1 (4) 2 (8) Child 5. and the pre-procedure rating associated with the child's rating of anxiety and pain. atric populations. / Journal of Pediatric Nursing 38 (2018) 1–7 5 Table 2 Table 4 Ratings of anxiety.01.001.2 25 1. Benjamin et al. Russell et al.0 25 4.48 ± 3.12 ± 2.03 Observer pain −0.0 ± 1. pain when the Buzzy device was used during injection. N (%) Standard. which may be due in part to the fact better than expected and no parent rated the visit as worse than expect. there was no significant difference in improve pain scores (Benjamin et al. Parent ratings of satisfaction scale (FLACC) was used to assess child pain. would remain significant in predicting child. . pain.25 0.43⁎⁎⁎ – – – Child expected pain 0. Age was the most strongly associated factor associated with child pain upon multivariate analysis. 2009).39⁎⁎ −0. These results are quite analysis. 2012). when asked to undergoing routine vaccinations and reported that the device did not rate their overall visit experience.18 ± 3. the device did not significantly impact their level of pre-procedure anxiety or how Satisfaction much they expected the injection to hurt.08 – Parent anxiety −0. R.04 0. Pre-procedure anxiety Buzzy Control t p-Value Response Buzzy. In addition.80 Don't know 2 (8) 7 (28) Observer 3.08 25 1. in this study pre-procedure anxiety and expecta- tors. Rather.E.6 25 5.62⁎⁎⁎ 0.004 Observer 3. children rated their own pain. because BMI and age were both associated on univariate ings were associated with post-procedure pain.27⁎ −0.14 0. Finally.34 ± 3.54⁎⁎⁎ 0. It was possible to obtain child ratings inquiry as to whether they would want their child to receive the Buzzy for all injections because of the included age ranges. It has been suggested that very stated that they would definitely or probably want to use the Buzzy dur.58 0.01 0.55 0.03 0. and nurses rated all partic- were more strongly correlated with the parent's rating of their child's ipants' pain. However. tion of pain were collected separately to determine whether those rat- reported pain.2 25 −2. ⁎⁎ p b 0. a few When asked specifically about their child's experience receiving a nee. procedure pain compared to post-procedure pain. as univariate association of these factors were both children reported higher pain scores.58.0 25 4.38⁎⁎ 0. Furthermore.10 −0.0 25 −1. their results sug- satisfaction rating. which were scaled from 1 (poor) to 10 (excellent) on exit survey. that the ice packs were not used by Benjamin et al.07 0. studied using the Buzzy device during various vaccination injections the device in a wider age range of participants.19 Parent pain −0.0 ± 1. BMI Age Parent satisfaction Child anxiety Child expected pain Child post pain Child anxiety −0.53 0. In the present ciation was followed by parent's rating of anxiety. Benjamin et al.34 ± 3.6 24 −0. The strength of asso. reports have aimed to describe its effects during immunization in pedi- dle poke. young children may not benefit from distraction techniques during nee- ing future needle procedures. age was one other important difference may be that in their investigation.69⁎⁎⁎ 0. which was not considered in Discussion the current study (CDC. Pearson correlation test was used to test the association of motor portion of the device was utilized. analysis.015 Definitely not 0 0 Satisfaction Needle procedure 8. and 64% of the control group not uniformly provide pain ratings.16 Overall visit 8.05.48 ± 3.15 0..12 ± 3. N (%) p-Value Parent 4.53⁎⁎⁎ ⁎ p b 0.40⁎⁎ −0.41 0. Buzzy has also been reported to have The results of this study suggest that thermomechanical stimulation positive effects for those undergoing injections.58 ± 1. the more strongly related to pain score than Buzzy group (Table 5).15 −0.25 −0. we also asked parents to indicate whether gested that the device was associated with higher pain scores in chil- their visit was the same. used the Buzzy device in 100 children tion higher than those that did not (Table 2). dle procedures due to emotional and cognitive factors (Cobb & Cohen.4 24 4.66⁎⁎ −0. On chi-square dren who were 4 years of age and older. ordinal variable regression was used to determine which fac.82 25 7.2 24 −0.34 ± 3. and was moderately study. While children reported lower strong and significant (Table 3).48⁎⁎ −0.70⁎⁎⁎ – – Child post pain −0. ⁎⁎⁎ p b 0. p b 0.58 ± 3.0 25 −1. Additionally. a different pain pain and anxiety ratings with satisfaction.09 0. 88% of the Buzzy group responded cluded younger children ranging from 2 months to 7 years who could positively (definitely yes or probably).18 −0.65⁎⁎⁎ 0.56⁎⁎⁎ −0.12 Better 19 (76) 8 (32) Child 4. better.58⁎⁎⁎ 0.4 24 4. Our findings suggest analysis.. Parent satisfaction with the procedure and overall visit was strongly associated with the anxiety Parent satisfaction was compared by Student t-test for questions and pain they perceived their child to have experienced. parents whose child received Buzzy did not rate their satisfac.37⁎⁎⁎ −0. or worse than expected.56 ± 3.4 25 3.25 0.92 ± 3.001). The main outcome measure was the difference in pre- pain than any other variable (R = 0.22 Worse 0 (0) 0 (0) Definitely yes 10 (40) 8 (32) N/A Post-procedure pain Probably 12 (48) 8 (32) Parent 4.20 ± 2.6 25 −0.80 Same 6 (24) 17 (68) 0. both Buzzy and age remained significant predictors. in- device during future needle sticks. While most studies of Buzzy have focused on venous access. In addition to venous access.49⁎⁎⁎ 0. parents of Buzzy recipients more frequently rated the visit as different from the current report.86 24 7. Finally.58 0.13 significantly decreased child-reported pain over a wide range of ages.41⁎⁎ −0. In response to the was of anxiety rather than pain.80 0. correlation tests suggested that younger post procedure pain. and satisfaction compared by t-test.16 −0. Parental satisfaction response by treatment group and preference for future use of Buzzy. While BMI was no longer associated with pain on multivariate that child-reported anxiety is not related to their reported pain. researchers categorized the type of vaccination as low pain or high pain according to CDC recommendations. Redfern et al. from 5 to over 25 years Table 3 Pearson correlation tests between continuous variables.01 −0. 2016).18 ± 3.43⁎⁎ 0.49⁎⁎⁎ Observer anxiety −0. the level reported by parents in procedures. Children under are not aware of any research of this device having incorporated this 13 who used both the Buzzy device and lignocaine reported significant.4772 0. four different nurses who were not involved in the study ing to needle phobia that may impact adherence to immunization administered the vaccines. possibly lead- ing. 2016). tions for pain relief continue to evolve and be offered in the inpatient enced by children (Fallah. / Journal of Pediatric Nursing 38 (2018) 1–7 Table 5 study.9949 0. the 2011). measure. 41% of included adults chose Further research to determine the optimal age at which to offer such both interventions (Russell et al. amounts of pressure while injecting subjects.6. 2012). however.E.7 vs 1. Also. Importantly. it is possible that these vaccines may quences. cost and time can be significant barriers that limit the search staff members consented patients and served as observers which value perceived in attempting to prevent this pain (Connelly. Examination regarding the effect of olds undergoing routine DTaP immunization in Turkey (Canbulat the device on ease of procedures for the healthcare provider.3291 2. as is more detailed investigation into the The impact of Buzzy on vaccination pain was also reported in 7 year impacts on parental satisfaction. 2014). Both the con- trol and Buzzy groups rated their pain lower than in our study. 2016). Mea- Previous NS 1 0. & Binesh.05).3184 0.and parent- cause the injections occurred monthly.09 per use (Baxter et al. as our results Conclusion suggest that age was more strongly associated with reported pain than was the use of the Buzzy device.0401 Gender Female 1 1. group reported significantly lower pain than the controls. unlike the current during routine immunization can significantly impact the pain reported results. which was not accounted for using inter-rater reliability test.5395 Intercept 4 1 2.2597 0.2882 0.3764 0. negative experiences can have very real. long-term conse- erage more injections overall.4865 0.0036 Magnusson. Analysis of maximum likelihood estimates It is possible that being part of the research study could have impacted Parameter DF Estimate Standard Wald Pr N both groups' satisfaction. First.6432 0.0772 11. possibly Clinical Implications because only one low pain vaccine was being injected. which about the amount of pain their children experience with vaccine injec- could have caused bias in both the child and parent ratings.0835 out additional intervention allows for better estimate of effect. Previous re.1080 child-reported pain relief is greater than that appreciated by parent re- Intercept 3 1 2. Pain Scale was modified for ease and consistency.7903 1.8537 b0.. Recent research has indicated that parents are often concerned observers and children were not blinded to the intervention. being administered. Lastly. As interven- are administered can significantly impact the amount of pain experi. Significant The results of this study suggest that thermomechanical stimulation differences in observer-rated pain was also reported. 2015). ly lower pain scores than those who used lignocaine alone (3.6 R. Williams. Additionally. The fact that those scores were not significantly different be- of age during non-immunization intramuscular injections (Russell. Intercept 1 1 6. subjects were given reported pain and anxiety was an important strength. could introduce variabilities in the presentation to subjects and observ.144 0. while both com- bination and single injections were included in this analysis.6822 1. five re. Offering an effective intervention for prevention of pain and have differed in the amount of pain they typically induce. Easy to use.5611 0. Likewise. p b 0. Some individual parents voiced appreciation of our initiative to Ordinal variable regression model. the were able to use patients as their own controls prior to intervention. possibly due to the large sample size included in that report.1361 1. study of satisfaction and its association with child. search has shown that even the order in which combination vaccines which is especially important for routine immunizations. the Buzzy device has demonstrated improved pain ratings .0001 There were also significant strengths of the study.0740 0.. rather. In dren were approached for consent and explained the purpose of the this study. There are several known limitations related to this study.5830 0. However. The Future Directions authors suggested that younger patients were more likely to opt to use the device with lignocaine. the expectation for pain prevention will grow for outpatient Finally.1775 1. study and prevent children's pain in the free text space of the survey. these researchers as its impact on procedure time are possible areas of future research used the Wong Baker Faces Pain scale and used the device according focus.1181 that allocation was randomized prior to commencement to prevent Gender Male 1 0.3872 surement of the child's expected pain in order to allow the team to control for the possible bias of simply having an intervention was also a strength. as the intervention will not be adopted by healthcare providers to manufacturer's instructions. including the fact Group BUZZY 1 −0. setting.7545 0. as the authors the option of electing to use lignocaine and/or Buzzy. the intervention added Limitations approximately 30–50 s to injection time per patient and the reusable device is estimated to cost approximately $0.5098 1. 2014). there were no Anxiety and pain caused by routine procedures in the pediatric pop- criteria for inclusion surrounding the types or number of immunizations ulation may be underestimated by parents and healthcare providers. Parker.4426 0. Wallace. such that the use of Buzzy may have a different error chi-square ChiSq impact on satisfaction in everyday practice.3199 0.1489 0. Intercept 2 1 4. Ferdosian. use of the entire device according to manufacturer's Age 1 −0. tween groups suggests that other reports of similar types of studies may Nicholson. inexpensive interventions without significant both groups may have been affected by the fact that all parents and chil.7351 2. Moreover. Negative experiences in child- er ratings.0008 instructions compared to standard of care in a controlled manner with- BMI 1 −0. a validated Also of importance is that the use of this device may impact parent sat- anxiety tool for children was not used.4340 8.4571 bias.3459 3. The fact that we in- cluded a wide range of ages may have been a limitation. very few subjects chose to use the device alone. Clark. Previous research has shown that parent satisfaction is related to pain resolution. be. to lessen anxiety may improve immediate and distant adherence. similar to the current findings (Magaret. 2002).3700 0.. the Wong Baker Faces isfaction by improving the child's experience of pain and anxiety. Participants randomized to the Buzzy if it is seen as a barrier to care. an intervention is warranted.0428 2. as well Sahiner et al..6277 16. & Hedges. Similar to the current study. investment of time are most likely to be successfully implemented. Additionally.0622 port. & Naidu. however.5529 0. Redfern et al. however.7477 0.3133 42. and may have used different techniques or recommendations in childhood and as an adult (Taddio et al. hood may be more detrimental than previously believed. the researchers not have been significantly impacted by non-blinding bias. however. Unlike the current study. Gholami. & Schurman. and that Intercept 5 1 0. by children over a wide range of ages. Warden. tion. 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