Journal of Pediatric Nursing 38 (2018) 17

Contents 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 signicant 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 ofce 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 signicantly 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 signicantly between groups, but was strongly associated with
parent-reported pain scores.
Conclusions: Thermomechanical stimulation with the Buzzy device signicantly 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
Procedures that require a needle stick are among the most common
procedures for pediatric patients in the health care setting and are a
source of pain (Cummings, Reid, Finley, McGrath, & Ritchie, 1996; Inal
& Kelleci, 2012a). Routine vaccination has been suggested to be the
most common cause of iatrogenic pain during childhood (Taddio et al.,
2009). The pain that accompanies these procedures may induce anxiety
in both pediatric and adult patients, with signicant consequences. Nee-
dle phobia is estimated to affect approximately 10%20% of the popula-
tion (Hamilton, 1995; Taddio et al., 2012). While it is believed that a
majority of needle phobia is due to genetic factors and the experience
1
No funding was received for the support and conduct of this research project.
2
The authors have no relevant nancial disclosures or conicts of interest to report.
Corresponding author at: Center for Health Services, 2150 W Central Ave, Suite K,
Toledo, OH 43606, United States.
E-mail address: Stephanie.sibrel@promedica.org (S. Sibrel).
of vasovagal reexes, the remaining 30% are considered classic phobias
arising due to traumatic experiences, particularly during pediatric
venipunctures in which the patient perceives that medical personnel
completed procedures without any effort to relieve pain or anxiety
(Lynn, 2010). Fear or anxiety associated with needle procedures does
not always resolve with time or age, and may result in delays in care
or avoidance of treatment in both pediatric and adult patients (Taddio
et al., 2010). Specically, the success of immunization programs has
been suggested to be impacted in part due to fear-induced non-
compliance. Managing the emotional and physical effects of needle pro-
cedures has become an important part of nursing practice, and inter-
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-
ducing pediatric pain during venipuncture including pharmacologic
(EMLA cream), behavioral distractions (music, video games, kaleido-
scopes), tactile interventions (stroking, ShotBlocker), sweet solutions
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.
2 R.E. Redfern et al. / Journal of Pediatric Nursing 38 (2018) 17
sprays), with varying results. Fewer studies have focused on the impact
of intervention on immunization pain in pediatric populations. The
effects of EMLA and vapocoolant spray were studied in infants using
duration of cry as a measure of pain with no impact compared to
breastfeeding during vaccination (Gupta et al., 2017). Similarly, a sys-
tematic review of interventions suggested that vapocoolant sprays are
not effective in preventing vaccination pain in children, however
EMLA creams were successful when compared with control (Shah
et al., 2015).
In 1984, Bini et al. reported an interesting phenomenon: the re-
search group induced pain in healthy research subjects using electrical
stimulation in order to test whether common maneuvers such as vibra-
tion, massage, warming, or cooling would affect subjects' pain experi-
ence (Bini, Cruccu, Hagbarth, Schady, & Torebjork, 1984). Vibration
provided the most effective response on its own, however, a combina-
tion of vibration and cooling provided the most potent analgesic effect
of those investigated, at times completely inhibiting moderate pain.
Though impressive pain reduction was observed when cold and vibra-
tion were combined (thermomechanical stimulation), the two have
not been used in conjunction in a clinical setting until recently.
The Buzzy device, a vibrating motor with ice pack, combines multi-
ple approaches by supplying cold analgesia, tactile stimulation, and dis-
traction. Buzzy is thought to provide pain relief via gate control theory,
by stimulating nerves with cold to close the fast pain gate. It is hypoth-
esized that by simultaneously stimulating A mechanoreceptors with
vibration, one can also close the fast pain gate via presynaptic inhibition
at the dorsal horn; the combination of the two would provide optimal
pain relief (Melzack & Wall, 1965). Pilot data in adults demonstrated
greater pain relief using Buzzy compared to vapocoolant sprays
(Baxter, Leong, & Mathew, 2009). Similarly, studies investigating the
use of this device in pediatric populations have also demonstrated supe-
rior pain relief in children while conrming the feasibility of its use in a
fast-paced care setting (Baxter, Cohen, McElvery, Lawson, & von Baeyer,
2011).
Most reports of the device suggest it provides signicant pain relief,
however the majority of these studies completed in pediatric popula-
tions focused on children undergoing venous cannulation or venous ac-
cess for blood draws (Baxter et al., 2011; Inal & Kelleci, 2012b, 2017;
Moadad, Kozman, Shahine, Ohanian, & Badr, 2016; Whelan,
Kunselman, Thomas, Moore, & Tamburro, 2014). A recent study report-
ed that Buzzy signicantly reduced pain during venipuncture in pediat-
ric patients with cognitive impairment as well (Schreiber et al., 2016).
While these studies have given some evidence of the device's efcacy,
few have focused on thermomechanical stimulation during pediatric
immunization. Benjamin et al. reported that vibration therapy alone
(without cold analgesia) was not effective in reducing immunization
pain (Benjamin, Hendrix, & Woody, 2016). However, a recent study of
both cold and vibration during DTaP vaccine injection indicated that sig-
nicant pain reduction was achieved per child self-report and observer
scores (Canbulat Sahiner, Inal, & Sevim Akbay, 2015). This study aimed
to determine whether Buzzy is effective over a range of vaccine injec-
tions and child ages.
Objective
The main objective of this study was to determine whether the
Buzzy thermomechanical system reduced procedural pain as measured
by the Wong Baker Faces Pain Scale (Wong, Hockenberry-Eaton,
Wilson, Winkelstein, & Schwartz, 2001) during routine vaccination in-
jections at well visits in a pediatric population. The secondary objectives
included the evaluation of whether Buzzy affected pre-procedural anx-
iety in these patients and whether use of the device affects parent satis-
faction compared to those receiving standard of care using 110 Likert
scale questions as well as a categorical rating of better, same, or worse
than expected rating for overall experience.
Methods
Design
This open label randomized clinical trial was conducted at
ProMedica Toledo Hospital's Center for Health Services from April
2016 through September 2016 and assessed the efcacy of Buzzy during
a vaccine injection. The necessary sample size to demonstrate a statisti-
cally signicant difference in child-reported pain was calculated prior to
enrollment. Assuming mean pain scores 3.0 1.5 and 4.0 2.0 the ex-
perimental and control groups in order to achieve 80% power at a signif-
icance level of 0.05, it was determined that 50 patients were needed per
group, as previously described (Inal & Kelleci, 2012b; Julious, 2004).
Preliminary analyses were planned in order to allow for early termina-
tion if signicance was reached at the halfway point of recruitment for
this project. A randomization schedule was created by research staff
using www.randomizer.org in advance of recruitment to assign patients
to either receive the Buzzy intervention or standard of care (no pain-
reducing intervention) during injection. Folded paper tags with group
allocation were placed into sequentially numbered, sealed envelopes
and opened at the time of consent. Neither parents, children, nor re-
search staff were blinded to the group assignment.
Participants
Children who were at least 3 through 18 years of age were eligible to
participate if undergoing routine vaccination injection at their annual
well visit and were Buzzy nave. Participants were excluded if Reynaud's
syndrome or sickle cell disease with extreme sensitivity to cold was
present (per manufacturer's recommendation); there was a break or
abrasion on the skin where the device would be placed; nerve damage
was present which would affect the extremity being injected;
neurodevelopmental delays or verbal difculties were present; analge-
sia had been used within the past 6 h; or if they had been previously ex-
posed to the Buzzy device. The number of injections required during the
visit was not a factor in patient inclusion or exclusion so that children of
all ages would be eligible to be included. The local Institutional Review
Board reviewed and approved this study prior to commencement. Par-
ents or legal guardians provided written informed consent for all partic-
ipants. Verbal assent was gained from children who were 36 years of
age and written assent was obtained from all children who were
7 years of age and older.
Setting
Subjects were enrolled within a single pediatric primary care ofce
of this urban community care center, a medical ofce building on the
campus of ProMedica Toledo Children's Hospital and ProMedica Toledo
Hospital. The center includes multiple primary care and specialty physi-
cian ofces, diagnostic testing, and behavioral health services.
ProMedica Toledo Hospital is a 794-bed tertiary care center with over
30,000 annual admissions, accredited by The Joint Commission and lo-
cated in Toledo, OH. The surrounding area is urban, with about
280,000 residents, of which approximately 65% are Caucasian, 27%
African American, and 7% Hispanic or Latino.
Test Device
The experimental device evaluated in this study was applied to pa-
tients randomized to the experimental group. The Buzzy device (MMJ
Labs, Atlanta, GA) is a reusable, battery-operated plastic vibrating
motor resembling a bee or ladybug that combines cold and vibration
using a thin (disposable or reusable) ice pack (wings). In this study, re-
usable ice packs were used and were solidly frozen prior to every appli-
cation. The device can be secured to the patient with the use of an
adjustable tourniquet or by pressing and holding the device in place
 R.E. Redfern et al. / Journal of Pediatric Nursing 38 (2018) 17
manually. Per the manufacturer's instructions, the device was held di-
rectly over the site of injection for 30 s, moved 3 to 5 cm proximal to
the site immediately prior to injection, and held in place during the en-
tirety of the needle stick. This is due in part to the fact that vasoconstric-
tion is not a concern during injection as it could be during venous
cannulation or access for blood draw. Distraction cards are available
for use in conjunction with the device, but were not used in this study.
Children randomized to the control group were provided no interven-
tion or distraction during injection, however, parents were not restricted
from soothing children. Small children were allowed to sit on a parent's
lap, however, no active distraction was provided. Parents stayed in the
room with all children during the entirety of the procedure. Four nurses
who were not part of the research team delivered the injections.
Procedure and Instruments
The device was shown to parents and children prior to enrollment,
and children were allowed to touch and turn on the device if they
chose. Upon provision of consent, parents were asked to complete a
brief demographic form developed by the authors to provide back-
ground information prior to the needle stick. The demographic form
asked how many vaccinations their child had experienced in the past,
whether they had ever exhibited a vasovagal response to a needle
stick, and whether the parent believed that the child was more fearful
of needle sticks than other children of the same age. Parents also report-
ed race, age, and gender of the child. Research staff recorded the child's
BMI as assessed by clinical staff during the well visit, the number of in-
jections, and location of injections during the visit.
Because the explanation of the device during the consent process
could affect the child's expectation of and subsequent perception of
pain, researchers asked each participant to rate how much they thought
the needle stick was going to hurt prior to the vaccine injection, using
the Wong Baker Faces Pain Scale (Wong et al., 2001). The Wong Baker
Faces Pain Scale has been shown to be valid and reliable in children
3 years of age and older; 15 min test-retest reliability has been reported
to be high with r = 0.90 and Cronbach's = 0.93 (Keck, Gerkensmeyer,
Joyce, & Schade, 1996; Luffy & Grove, 2003; Wong et al., 2001). Children
under 3 years of age were not eligible for inclusion in order to allow for
use of a single, valid pain scale. In addition, children were asked to rate
Fig. 1. Instruments used to measure anxiety and pain. Wong Baker Faces Pain Scale (top) and modication for anxiety measurement (bottom).
3
how scared they were about the needle stick using this scale, which was
modied to 6 categories matching the face: not scared; a little scared; a
little more scared: even more scared; really scared; and most scared
(Fig. 1). This was done for consistency and ease of rating for younger
children involved in the study. The parent was asked to independently
rate how scared or anxious they felt their child was about the injection
before the child rated it, and an independent observer also rated the
child's pre-procedural anxiety before the child rated it, both using this
modied scale. Because parents and children were not in separate
rooms, all attempts were made to blind each rater to one another's re-
sponses (moved to opposite ends of room, papers were folded and/or
ipped over after rating), which was discussed with parents immedi-
ately following consent, when forms were distributed. One of ve mem-
bers of the research team recruited each patient, serving as the observer
and collecting pre- and post-test data.
Immediately following the injection, the parent and observer rated
the child's reaction and experience of pain independently of one anoth-
er prior to the child's rating; the child was then asked to rate how much
the injection hurt using the Wong Baker Faces Pain scale. Finally, par-
ents were asked to complete a brief satisfaction questionnaire before
leaving the ofce. This was an unvalidated questionnaire developed by
the authors. Parents were asked to rate their child's overall experience
and their experience specically with the injection on a ten point scale
from poor to excellent. They were also asked to rate whether the expe-
rience was the same, better, or worse than expected, and whether they
would prefer for their child to receive the Buzzy device in the future
when a needle stick is required.
Data Analysis
SAS version 9.2 (SAS Institute Inc., Cary, NC, USA) was used for statis-
tical analysis. Descriptive statistics detailed patient characteristics upon
study entry. Chi squared and Student t-tests were used to investigate
categorical and continuous variables, respectively. The association of
parent, child, and observer ratings as well as the association of pain rat-
ings with satisfaction ratings were completed using Pearson correlation
coefcient analysis. Post-hoc ordinal variable regression was performed
to examine the signicance of potential factors affecting children's rat-
ings of post-procedural pain. Missing data was imputed using Markov
4 R.E. Redfern et al. / Journal of Pediatric Nursing 38 (2018) 17

Chain Monte Carlo method with multiple imputations. Signicance Table 1

level was set at p b 0.05 in advance of recruitment. Self-reported patient7 characteristics on study entry.

Characteristic Buzzy N Control N t p-Value

Results Age 10.7 4.7 25 10.5 4.7 25 0.2 0.85
BMIa 23.68 7.8 20 21.2 7.5 22 1.05 0.30
Demographics Mother's age 33.7 7.8 24 33.2 6.6 24 0.26 0.80
Father's age 36.5 8.1 17 35.9 8.7 21 0.21 0.84
Child's expected pain 5.00 3.4 24 5.72 3.2 22 0.76 0.22
Fifty-one children undergoing routine vaccination consented to par-
ticipation in the study, 26 were randomized to the Buzzy group and 25 Buzzy Control Chi-square p-Value
to the control (no intervention) group (Fig. 2). One child was consented
Gender
and withdrawn after randomization to the Buzzy group due to age. The Female 15 17 0.35 0.56
mean age of the Buzzy group was 10.7 4.7 compared to 10.5 4.7 in Male 10 8
the control group, which were not statistically different from one anoth- Race
er (p = 0.85, Table 1). No characteristic of interest varied signicantly African American 12 14 2.30 0.51
Caucasian 10 6
between groups, including BMI, gender, parent characteristics, and
Mixed race 3 4
number of previous needle sticks. The only variable that differed be- Hispanic 0 1
tween groups was the number of injections, wherein the proportion of Education of mom
patients randomized to the Buzzy group receiving two or more injec- High school and below 14 10 2.09 0.15
tions at the current visit was signicantly higher than in the control Above high school 9 15
Education of dad
group. There were no adverse events in either group. High school and below 12 15 0 1.0
Above high school 4 5
Anxiety and Pain Previous needle procedures
b4 15 18 1.86 0.17
4 and above 10 5
The anxiety ratings by children in both groups were compared by
Number of injections
Student t-test; the means did not differ signicantly between control One 9 16 3.92 0.047
and Buzzy group (5.18 vs 4.34, p = 0.43). However, in comparing the Two or more 16 9
post-procedure pain ratings given by children, those in the Buzzy a
Calculated from current well visit height and weight measurements.
group reported signicantly lower pain than those in the control
group, with a mean difference of 2.39 (95% CI 0.48 to 4.24, t =
2.53, p = 0.015, Table 2). Mean pain reported between those receiv- comparing ratings of post-procedure pain, the Buzzy group was rated
ing one injection (4.3 3.1) and those receiving more than one injec- lower than the control by the observers (p = 0.04), but not signicantly
tion (5.2 3.8), without considering group assignment, was not by parents (p = 0.09) compared to the control group. Investigation into
statistically different on Student t-test (p = 0.36). Furthermore, in com- the association between child, parent, and observer ratings revealed
paring how much the children thought the injection would hurt, 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, though only slightly
group was 5.72 compared to 5.0 in the Buzzy group (p = 0.45, Table 2). (R = 0.49 vs 0.53, both p b 0.001, Table 3). 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. Neither parents nor observers rated patients in the with child ratings (Table 3). Pearson correlation tests also suggested
Buzzy group to be less anxious than in the control group (Table 2). In that BMI and age may each be independently related to child-reported

Fig. 2. Participant ow and allocation.

 R.E. Redfern et al. / Journal of Pediatric Nursing 38 (2018) 17 5

Table 2 Table 4
Ratings of anxiety, pain, and satisfaction compared by t-test. Parental satisfaction response by treatment group and preference for future use of Buzzy.

Pre-procedure anxiety Buzzy Control t p-Value Response Buzzy, N (%) Standard, N (%) p-Value

Parent 4.34 3.4 24 4.58 1.6 24 0.25 0.80 Same 6 (24) 17 (68) 0.004
Observer 3.18 3.0 25 4.48 3.0 25 1.58 0.12 Better 19 (76) 8 (32)
Child 4.34 3.6 25 5.18 3.6 25 0.80 0.22 Worse 0 (0) 0 (0)
Denitely yes 10 (40) 8 (32) N/A
Post-procedure pain Probably 12 (48) 8 (32)
Parent 4.34 3.4 24 4.58 3.2 24 0.25 0.80 Don't know 2 (8) 7 (28)
Observer 3.12 3.0 25 4.48 3.0 25 1.58 0.12 Probably not 1 (4) 2 (8)
Child 5.92 3.4 25 3.56 3.2 25 2.53 0.015 Denitely not 0 0
Satisfaction
Needle procedure 8.0 1.86 24 7.20 2.08 25 1.41 0.16
Overall visit 8.0 1.82 25 7.12 2.2 25 1.55 0.13 signicantly decreased child-reported pain over a wide range of ages.
Age was the most strongly associated factor associated with child pain
upon multivariate analysis; correlation tests suggested that younger
post procedure pain, as univariate association of these factors were both children reported higher pain scores. While children reported lower
strong and signicant (Table 3). pain when the Buzzy device was used during injection, the device did
not signicantly impact their level of pre-procedure anxiety or how
Satisfaction much they expected the injection to hurt. 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.
which were scaled from 1 (poor) to 10 (excellent) on exit survey. While most studies of Buzzy have focused on venous access, a few
When asked specically about their child's experience receiving a nee- reports have aimed to describe its effects during immunization in pedi-
dle poke, parents whose child received Buzzy did not rate their satisfac- atric populations. Benjamin et al. used the Buzzy device in 100 children
tion higher than those that did not (Table 2). In addition, when asked to undergoing routine vaccinations and reported that the device did not
rate their overall visit experience, there was no signicant difference in improve pain scores (Benjamin et al., 2016). Rather, their results sug-
satisfaction rating. However, we also asked parents to indicate whether gested that the device was associated with higher pain scores in chil-
their visit was the same, better, or worse than expected. On chi-square dren who were 4 years of age and older. These results are quite
analysis, parents of Buzzy recipients more frequently rated the visit as different from the current report, which may be due in part to the fact
better than expected and no parent rated the visit as worse than expect- that the ice packs were not used by Benjamin et al., only the vibrating
ed (Table 4). Pearson correlation test was used to test the association of motor portion of the device was utilized. Additionally, a different pain
pain and anxiety ratings with satisfaction. Parent ratings of satisfaction scale (FLACC) was used to assess child pain, and nurses rated all partic-
were more strongly correlated with the parent's rating of their child's ipants' pain. The main outcome measure was the difference in pre-
pain than any other variable (R = 0.58, p b 0.001). The strength of asso- procedure pain compared to post-procedure pain. In the present
ciation was followed by parent's rating of anxiety, and was moderately study, children rated their own pain, and the pre-procedure rating
associated with the child's rating of anxiety and pain. In response to the was of anxiety rather than pain. 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; Benjamin et al. in-
device during future needle sticks, 88% of the Buzzy group responded cluded younger children ranging from 2 months to 7 years who could
positively (denitely yes or probably), and 64% of the control group not uniformly provide pain ratings. It has been suggested that very
stated that they would denitely or probably want to use the Buzzy dur- young children may not benet from distraction techniques during nee-
ing future needle procedures. dle procedures due to emotional and cognitive factors (Cobb & Cohen,
Finally, ordinal variable regression was used to determine which fac- 2009). Furthermore, in this study pre-procedure anxiety and expecta-
tors, when taken together, would remain signicant in predicting child- tion of pain were collected separately to determine whether those rat-
reported pain, because BMI and age were both associated on univariate ings were associated with post-procedure pain. Our ndings suggest
analysis. While BMI was no longer associated with pain on multivariate that child-reported anxiety is not related to their reported pain. Finally,
analysis, both Buzzy and age remained signicant predictors; age was one other important difference may be that in their investigation, the
more strongly related to pain score than Buzzy group (Table 5). researchers categorized the type of vaccination as low pain or high
pain according to CDC recommendations, which was not considered in
Discussion the current study (CDC, 2012).
In addition to venous access, Buzzy has also been reported to have
The results of this study suggest that thermomechanical stimulation positive effects for those undergoing injections. Russell et al. studied
using the Buzzy device during various vaccination injections the device in a wider age range of participants, from 5 to over 25 years

Table 3
Pearson correlation tests between continuous variables.

BMI Age Parent satisfaction Child anxiety Child expected pain Child post pain

Child anxiety 0.01 0.27 0.43

Child expected pain 0.04 0.18 0.14 0.70
Child post pain 0.48 0.56 0.37 0.03 0.08
Parent anxiety 0.10 0.01 0.54 0.62 0.43 0.19
Parent pain 0.40 0.41 0.58 0.66 0.09 0.49
Observer anxiety 0.15 0.15 0.38 0.69 0.65 0.03
Observer pain 0.25 0.39 0.49 0.16 0.07 0.53
p b 0.05.
p b 0.01.
p b 0.001.
6 R.E. Redfern et al. / Journal of Pediatric Nursing 38 (2018) 17

Table 5 study. Some individual parents voiced appreciation of our initiative to

Ordinal variable regression model. study and prevent children's pain in the free text space of the survey.
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, such that the use of Buzzy may have a different
error chi-square ChiSq impact on satisfaction in everyday practice. Previous research has
shown that parent satisfaction is related to pain resolution, and that
Intercept 5 1 0.7903 1.2882 0.3764 0.5395
Intercept 4 1 2.1361 1.3291 2.5830 0.1080 child-reported pain relief is greater than that appreciated by parent re-
Intercept 3 1 2.5098 1.3459 3.4772 0.0622 port, similar to the current ndings (Magaret, Clark, Warden,
Intercept 2 1 4.1775 1.4340 8.4865 0.0036 Magnusson, & Hedges, 2002).
Intercept 1 1 6.6822 1.6277 16.8537 b0.0001 There were also signicant strengths of the study, including the fact
Group BUZZY 1 0.6432 0.3133 42.144 0.0401
Gender Female 1 1.1489 0.7351 2.4426 0.1181
that allocation was randomized prior to commencement to prevent
Gender Male 1 0.5611 0.7545 0.5529 0.4571 bias. Additionally, use of the entire device according to manufacturer's
Age 1 0.2597 0.0772 11.3184 0.0008 instructions compared to standard of care in a controlled manner with-
BMI 1 0.0740 0.0428 2.9949 0.0835 out additional intervention allows for better estimate of effect. Mea-
Previous NS 1 0.3199 0.3700 0.7477 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. The fact that those scores were not signicantly different be-
of age during non-immunization intramuscular injections (Russell, tween groups suggests that other reports of similar types of studies may
Nicholson, & Naidu, 2014). Unlike the current study, the researchers not have been signicantly impacted by non-blinding bias. Lastly, the
were able to use patients as their own controls prior to intervention, be- study of satisfaction and its association with child- and parent-
cause the injections occurred monthly. However, subjects were given reported pain and anxiety was an important strength, as the authors
the option of electing to use lignocaine and/or Buzzy. Children under are not aware of any research of this device having incorporated this
13 who used both the Buzzy device and lignocaine reported signicant- measure.
ly lower pain scores than those who used lignocaine alone (3.7 vs 1.6, p
b 0.05); however, very few subjects chose to use the device alone. The Future Directions
authors suggested that younger patients were more likely to opt to
use the device with lignocaine, however, 41% of included adults chose Further research to determine the optimal age at which to offer such
both interventions (Russell et al., 2014). an intervention is warranted, as is more detailed investigation into the
The impact of Buzzy on vaccination pain was also reported in 7 year impacts on parental satisfaction. Examination regarding the effect of
olds undergoing routine DTaP immunization in Turkey (Canbulat the device on ease of procedures for the healthcare provider, as well
Sahiner et al., 2015). Similar to the current study, 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, as the intervention will not be adopted by healthcare providers
to manufacturer's instructions. Participants randomized to the Buzzy if it is seen as a barrier to care.
group reported signicantly lower pain than the controls. Both the con-
trol and Buzzy groups rated their pain lower than in our study, possibly Clinical Implications
because only one low pain vaccine was being injected, while both com-
bination and single injections were included in this analysis. Signicant The results of this study suggest that thermomechanical stimulation
differences in observer-rated pain was also reported, unlike the current during routine immunization can signicantly impact the pain reported
results, possibly due to the large sample size included in that report. by children over a wide range of ages. Importantly, the intervention is
quick and easy to implement at minimal cost; the intervention added
Limitations approximately 3050 s to injection time per patient and the reusable
device is estimated to cost approximately $0.09 per use (Baxter et al.,
There are several known limitations related to this study. First, the 2011). Recent research has indicated that parents are often concerned
observers and children were not blinded to the intervention, which about the amount of pain their children experience with vaccine injec-
could have caused bias in both the child and parent ratings. Also, ve re- tion, however, cost and time can be signicant barriers that limit the
search staff members consented patients and served as observers which value perceived in attempting to prevent this pain (Connelly, Wallace,
could introduce variabilities in the presentation to subjects and observ- Williams, Parker, & Schurman, 2016). Negative experiences in child-
er ratings, which was not accounted for using inter-rater reliability test- hood may be more detrimental than previously believed, possibly lead-
ing. Likewise, four different nurses who were not involved in the study ing to needle phobia that may impact adherence to immunization
administered the vaccines, and may have used different techniques or recommendations in childhood and as an adult (Taddio et al., 2012).
amounts of pressure while injecting subjects. Moreover, a validated Also of importance is that the use of this device may impact parent sat-
anxiety tool for children was not used; rather, the Wong Baker Faces isfaction by improving the child's experience of pain and anxiety.
Pain Scale was modied for ease and consistency. The fact that we in-
cluded a wide range of ages may have been a limitation, as our results Conclusion
suggest that age was more strongly associated with reported pain
than was the use of the Buzzy device. Additionally, 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,
being administered. While patients in the Buzzy group did have on av- however, negative experiences can have very real, long-term conse-
erage more injections overall, it is possible that these vaccines may quences. Offering an effective intervention for prevention of pain and
have differed in the amount of pain they typically induce. Previous re- to lessen anxiety may improve immediate and distant adherence,
search has shown that even the order in which combination vaccines which is especially important for routine immunizations. As interven-
are administered can signicantly impact the amount of pain experi- tions for pain relief continue to evolve and be offered in the inpatient
enced by children (Fallah, Gholami, Ferdosian, & Binesh, 2016). setting, the expectation for pain prevention will grow for outpatient
Finally, in measuring satisfaction, the level reported by parents in procedures. Easy to use, inexpensive interventions without signicant
both groups may have been affected by the fact that all parents and chil- investment of time are most likely to be successfully implemented. In
dren were approached for consent and explained the purpose of the this study, the Buzzy device has demonstrated improved pain ratings
 R.E. Redfern et al. / Journal of Pediatric Nursing 38 (2018) 17
and patient satisfaction scores, with the majority of parents endorsing
their preference for its future use.
Funding
This research did not receive any specic grant from funding agen-
cies in the public, commercial, or not-for-prot sectors.
Acknowledgments
The authors would like to thank Dominique Dippman, BSN, RN, Taha
Hasan, Saif Jamil, and Austin Lee and for their assistance with data col-
lection. We would also like to thank the staff of ProMedica Pediatric
Clinic for assistance their support and assistance in completing this
project.
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