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Effects of vibration therapy in pediatric immunizations.

Vaccinations are one of the greatest public health success stories of the last century. Simple and cost-effective, they prevent an estimated 2 to 3 million deaths each year worldwide (U.S. Department of Health & Human Services [DHHS], 2010). In the United States, vaccines prevent approximately 42,000 deaths and 20 million illnesses, saving $13.6 billion in direct medical costs (Centers for Disease Control and Prevention [CDC], 2011b). Vaccines have helped increase the lifespan of Americans by 30 years and decrease mortality 14-fold (DHHS, 2010). Despite the proven benefit of vaccines, the majority of the states in the United States fall short of the CDC's Healthy People 2020 target immunization rates (CDC, 2011a). Specifically, only 4 of the 47 states receiving federal grants for immunization programs have met the national immunizations coverage goals of 95% or better for children entering kindergarten (CDC, 2011a).

Known barriers to vaccination include religious beliefs, media misinformation, parental distrust, lack of access (e.g., cost, transportation, lack of health insurance), and most significant to this current study, perceived potential harm or pain (Kimmel, Burns, Wolfe, & Zimmerman, 2007; Mills et al., 2005). Routine immunizations are the number-one cause of childhood procedural pain (Taddio, Ilersich, Ipp, Kikuta, & Shah, 2009), and up to 92.7% of younger children (aged 15 to 18 months) and 44.4% of older children (aged 4 to 6 years) show signs of serious distress during immunization administration (Jacobson et al., 2001). Not only does pain play a factor in immunization rates, but evidence also shows that children who experience discomfort in the past will have an increased perception of pain in the future (Helms & Barone, 2008; Taddio & Katz, 2005). Despite the long-term negative impact of these painful experiences, and despite the American Academy of Pediatric's (AAP) (2001) public position that pain and suffering need to be eliminated or assuaged whenever possible, few clinicians use pain relief techniques during immunization administration (Taddio et ah, 2009).

This article proposes to evaluate the effectiveness of vibration therapy alone, using the Buzzy[R] device, as a clinic tool for alleviating pain during routine vaccination. This type of therapy involves the pre-immunization application of vibration stimulus, often in combination with cold packs, at the injection site. As hypothesized by the gate-control theory, vibration therapy interferes with pain receptors at the site of injection leading to a reduced perception of pain (Melzack & Wall, 1965). If effective, this therapy could offer clinicians a simple, cost-effective method to help patients receiving injections.

Literature Review

Currently, a variety of pain-minimizing options exist for injections, including analgesia, distraction, external stimulus techniques, and the administration of sweet solutions for infants. However, each of these options has limitations that make them unviable for routine vaccination.

Pharmacologic

Various topical anesthetic options are available for injection pain relief. EMLA[R], a lidocaine-prilocaine cream has sometimes been shown to be effective at reducing immunization pain in children (Cassidy et ah, 2001; Dilli, Kucuk, & Dallar, 2009; Halperin, McGrath, Smith, & Houston, 2000). However, in one study, EMLA had no significant effect, and distraction was actually found to be more effective at decreasing distress during immunizations (Cohen, Blount, Cohen, Schaen, & Zaff, 1999; Cohen et al., 2006). Ametop gel (4% amethocaine) has been found to reduce pain with 1-year-olds receiving the measles, mumps, and rubella (MMR) vaccination (O'Brien, Taddio, Ipp, Goldbach, & Koren, 2004). Yet regardless of the effectiveness of individual topical anesthetic medications, the downsides to all of them are the constraints of time and cost. EMLA has a 60- to 90-minute onset time, while the onset time for Ametop is 30 to 45 minutes (Houck & Sethna, 2005). Both involve some minor costs for medication and an occlusive dressing, making topical anesthetics an unrealistic option for the outpatient setting.

Cold Analgesia

Cold therapy research in children is equivocal. Vapocoolant, an alkane cryotherapy spray, works within seconds, is inexpensive (less than $1 an application), and has also been shown to effectively relieve vaccination pain in adults (Mawhorter et al., 2004). Although some research has found it ineffective in pediatrics (Cohen et al., 2009; Goldman, Ipp, Manley, Weisbrot, & Taddio, 2009), other studies have found it as effective as EMLA, especially when combined with distraction (Reis & Holubkov, 1997). The downside of using vapocoolant is the rare, but considerable risk of freezing the skin when the application time exceeds 15 seconds (Mawhorter et al., 2004). This raises safety concerns about regular use of this product, especially in the pediatric population. Simpler forms of cryotherapy, such as the application of ice, have also been ineffective at reducing pain in children receiving vaccines (Taddio et al., 2009).

Behavioral Techniques: Music/Distraction

Behavioral approaches tend to be a good option for reducing immunization pain, although their effectiveness, cost, and time commitment are quite varied. Music therapy is generally beneficial, lowering overall distress of the child (Megel, Houser, & Gleaves, 1998), as well as reported pain (Kristjansdottir & Kristjansdottir, 2011; Noguchi, 2006). However, music studies tend to have small numbers of subjects resulting in underpowered trials, as well as variable musical conditions (live performers versus recorded music, listening versus playing music) (Mrazova, Celec, & Ing, 2010). Therefore, the results of these studies tend to be difficult to extrapolate to the general population. A meta-analysis of 15 distraction studies with immunizations found distraction beneficial, especially when engaging multiple senses or requiring specific behavioral responses, such as deep breathing, using party blowers, and bubble blowing (DeMore & Cohen 2005). However, the associated costs are high in terms of time, with an estimated 5 to 15 minutes required to train the child or parent. There also tends to be a limited age window of effectiveness, with distraction being most helpful in children under 7 years old (Kleiber & Harper, 1999) but not effective on children under 12 months of age (Cramer-Berness, 2007).

Sweet Solution

A well-proven treatment for immunization pain in infants is sweet solutions. A systematic review of 14 clinical trials using sucrose or glucose in infants up to 1 year of age found that administration of sweet solution prior to immunization reduced both the incidence and the duration of crying time (Harrison et al., 2010). It is known that newborns are more sensitive than adults to pain due to their immature nervous system and inability to suppress pain sensations (Dilen & Elseviers, 2010). Interestingly, the analysis revealed that the analgesic effect is stronger during the newborn period than with older infants. Though effectiveness in infants is suggested, it is ineffective for all other age groups. Therefore, like behavior and distraction discussed above, there is a very small window of age where sweet solution is effective.

Tactile Intervention

Tactile interventions, such as skin stroking or stimulation, have shown both favorable and unfavorable results. Stroking of the skin next to the injection site was found to reduce child injection pain (Taddio et al., 2009). However, the ShotBlocker[R], a small plastic U-shaped device with rounded nubs meant to stimulate skin surrounding the injection site in order to inhibit pain transmission, has not shown any degree of effectiveness in pain relief (Cobb & Cohen, 2009). Another tactile intervention, the Buzzy, which is used in the current study and will be described later, includes the simultaneous use of vibration and cold therapy. In a pilot study, the Buzzy was shown to be effective in children undergoing venipuncture (Baxter, Cohen, McElvery, Lawson & von Baeyer, 2011; Inal & Kelleci, 2012). Vibration therapy alone is effective at reducing adult subcutaneous anesthetic injection pain (Fayers, Morris, & Dolman, 2010). However, vibration alone has not yet been studied in children undergoing immunizations.

A model for understanding how tactile intervention techniques might reduce pain is based on the gate-control theory, described by Melzack and Wall in 1965. According to the gate control theory, there are "gates" in the nervous system that open and close, influencing nerve transmission. When the gates are open, pain signals from the periphery of the body are able to reach the brain, and pain sensations are perceived. However, gates may be opened and closed by many factors, including nonpainful stimuli. By stimulating mechanical nociceptors, touch or vibration may partially close a gate. Other pain impulses travelling along the same pathway are then inhibited from passing through the gate, thus decreasing perceived pain. Descending nerve impulses from the brain also influence these gate mechanisms, offering an explanation as to why psychological factors, such as previous painful experiences, can influence pain (Smeltzer, Bare, Hinkle, & Cheever, 2012).

In summary, all of the techniques that have been tried and shown to be effective at reducing immunization pain in the pediatric population are cost-prohibitive, time prohibitive, or impractical in an outpatient setting because of their narrow range of age appropriateness. Therefore, current proven treatments would require a practice to invest in numerous strategies to meet the needs of their diverse clients. For example, a basket of age-appropriate toys (e.g., sweet solution for infants, bubbles and pinwheels for toddler distraction) would need to be employed, but again, there are significant costs to this approach in terms of both products and training.

A universal tool would be the most practical and timesaving option. Of the various techniques, tactile strategies and especially vibration have not been widely explored. Vibration may offer the most potential to both effectively reduce pain in diverse populations, as well as meet the needs of general outpatient clinics because it is not limited by the developmental age of the child, nor is it cost or time prohibitive.

Purpose/Goal

The purpose of this study was to determine whether vibration therapy without cold analgesia reduces pain among children aged 2 months to 7 years undergoing routine vaccination at an urban clinic, compared to children receiving standard vaccination treatment. This age range was selected because the majority of immunizations occur in this age group. It is hypothesized that children receiving vibration therapy will have lower pain scores than those receiving typical treatment. The University of Alaska--Anchorage Institutional Review Board approved the research protocol. Site approval was obtained in writing from the clinical directors.

Method

Study Design

A randomized clinical trial was conducted to evaluate the effect of vibration therapy on pain. Data collection included a convenience sample of subjects recruited at two clinical sites. Once informed consent and child assent (from children over 5 years) was granted, children were randomly assigned to one of two treatment groups: vibration versus typical treatment. Those assigned to the intervention group received vibration via the Buzzy vibrating device 10 seconds prior to receiving the injection. The device was placed anatomically superior to the injection site, along the same skin dermatome. The nurse injected the immunization within approximately 0.5 centimeters from the device. The vibration device remained vibrating next to the skin while the injection was administered until after the needle was removed. If more than one injection was scheduled and two nurses were available for administration, then two vaccines were given simultaneously using two vibrating devices, one at each injection site. When one nurse was administering more than one injection in different locations (arm and leg, for example), then the vibration device was moved to each injection site prior to injection. If multiple injections were given sequentially, the most painful injection, such as MMR or Prevnar[R], was always administered last, as recommended by the Centers for Disease Control and Prevention (CDC, 2012). The control group received the scheduled immunization injection without vibration. Both groups were allowed to be held, soothed, comforted, and distracted by both the nurse and parent, as would have been normally done.

Subjects

A sample of 100 children was recruited from a consecutive patient population attending clinics for routine immunizations. All children, aged 2 months to 7 years, were invited to participate in the study. Before inclusion, children were shown the device, allowed to hold it, and given the choice of whether or not to they wanted to participate in the study. Exclusion criteria included the parent's inability to understand English. Random assignment to intervention (vibration therapy) (n = 50) or control (n = 50) group was determined by a computer-generated randomization list in clusters. The first clinical site was a state-sponsored monthly walk-in immunization clinic, offering free vaccinations to all children through the age of 18. The second site was a private group pediatric practice, with a diverse patient population, including those with private insurance, state-funded insurance, as well as the uninsured. Both clinics are located at an urban hospital campus in Anchorage, Alaska. Data were gathered for eight consecutive months at the immunization clinic, and five days at the group pediatric clinic.

Parents completed a brief form that included background demographic information about the child (age, gender), as well as medication information, including medications taken on the day of the immunization. Other recorded information included the number of immunizations received that day, needle length, injection site, and injection technique (subcutaneous versus intramuscular). Vaccine type was recorded as either high pain (MMR, PCV) or low pain (Hepatitis B, DTaP, Hib, Influenza, Varicella, Hepatitis A, and Pediarix).

Vibration Instrument

The Buzzy device is a reusable, 3-inch by 2-inch, FDA Class I minimal risk plastic device that looks like a bumble bee and can provide both steady vibration and cold therapy simultaneously (http://buzzy4shots.com). This device has been found to be an effective treatment in reducing venipuncture pain in children (Baxter et al., 2011; Inal & Kelleci, 2012) as well as adults undergoing venous annulation (Baxter, Leong, & Matthew, 2009), with no adverse events. The Buzzy device allows for cold packs to be placed next to the skin, but because cold therapy has not been shown to be consistently effective in children (Taddio et al., 2009), only vibration was included in the current study. Participating nurses reviewed a brief instructional video on the device prior to conducting the data collection.

Vaccinations

For the purposes of this study, routine vaccinations, as recommended by the CDC, included single and combination vaccinations for the following: Hepatitis B, DTaP, Haemophilus influenza type b (Hib), Pneumococcal (PCV), Polio (IPV), Influenza, MMR, Varicella, and Hepatitis A (CDC, 2012).

Each type of vaccination was categorized according to whether it is a high (MMR or PCV) or low pain injection (Hepatitis B, DTaP, Hib, IPV, Varicella, Hepatitis A) as described by the CDC (2012). If a child received any high pain immunization, such as MMR or PCV, then for analysis purposes researchers classified them as being in the high pain group. Only children receiving all low pain injections were placed in the low pain group.

Outcome Measures

FLACC pain score. Pain was assessed by the FEACC Scale, a pediatric behavioral tool designed to measure pain or discomfort in five separate categories: facial expression, leg movement, activity, cry, and consolability from a scale of 0 to 2 for each category, thereby resulting in a total score range of 0 to 10 (Merkel, Voepelkewis, Shayevitz, & Malviya, 1997). It has been validated for use in children aged 2 months to 7 years (Merkel et al., 1997).

Two nurses assigned each patient a FEACC score. The FEACC pain score was reviewed in depth with the research nurses. The two scores were first evaluated for inter-rater reliability, and then averaged for the purposes of analysis. To control for the baseline level of anxiety, pain scores were obtained at three time points: 30 seconds prior to injection, during the last injection of solution, and 30 seconds after the last needle is removed.

Analyses

Initial power calculations assumed a two-tailed hypothesis test with alpha set at a = 0.05 and power (1-[beta]) = 0.80. The researchers selected 2.0 as a clinically meaningful difference in the mean FLACC score difference, and 3.0 was selected as the standard deviation. Given these assumptions, 37 participants in each group were required to detect this difference. Patient characteristics, including age, gender, and vaccination type (high vs. low pain), were first compared according to their intervention status (vibration vs. standard care) using a Chi-square test (see Table 1).

A series of two independent-samples paired f-test was performed to determine if the two methods (vibration therapy versus control) produce significantly different pain from immunization. The difference between pre-injection scores and injection scores for recipients of vibration therapy was compared to the same difference in control scores; similarly, the difference between pre-injection scores and post-injection scores was compared between vibration therapy and control, and finally, the difference between injection and post-injection scores was compared. Prior scores were subtracted from the later scores, so higher numbers indicate higher pain at later time points.

Differences between vibration therapy and standard care were assessed overall, as well as within age categories (ages 2 months to 1 year, ages 1 to 4 years, and 4 to 7 years), and type of injection received (high pain versus low pain).

Results

Randomization led to evenly distributed demographic and descriptive characteristics, with no statistically significant differences between the physical vibration group and the control group (see Table 1). Roughly 70% of the population received only low pain vaccines, and the gender distribution was nearly 50% boys and girls.

Inter-rater reliability for the three pain scores (pre-injection, injection, and post-injection) was between 0.82 and 0.85. Overall, vibration led to no significant difference in the FLACC pain score, compared to standard treatment in any of the three-paired comparisons (pre-injection/injection, pre-/post-injection, and injection/post-injection). No differences were detected within the high and low pain sub-group analyses (see Table 2).

Neither the lowest age group (2 to 12 months old), nor the middle age group (12 months to less than 4 years) showed any significant differences between the treatment modalities. However, among those 4 years old and older, those receiving vibration therapy experienced a difference in pain scores that was statistically higher in the pre-/post-injection analyses (p = 0.045). Because the prior scores were subtracted from the later scores, this indicates that among those receiving vibration therapy, the later FLACC pain scores (both injection or post-injection) were significantly higher than their pre-pain score compared to those with standard care.

Discussion

The study results show that immunizations are painful experiences in all groups. Vibration therapy alone, however, did not appear to reduce immunization pain in children 2 months of age to 4 years of age (2 months to [less than or equal to] 1 year: p = 0.947, > 1 year to [less than or equal to] 4 years: p = 0.110). No significant differences in treatment effects were found aside from an elevated pain response in children aged 4 to 7 years who used vibration therapy (p = 0.046).

The gate control theory suggests that physical interventions should interfere with the ascending pain signal, reducing perceived pain. However, as suggested by Cobb and Cohen (2009), who found the ShotBlocker ineffective with immunization pain, perhaps some physical interventions are insufficient to effectively stimulate the nerves, and therefore, close the "gate." Previous research supports the idea that vibration in conjunction with another treatment might be necessary, such as vibration and cold therapy, which in combination have been shown to be effective in reducing pediatric venipuncture pain (Baxter et al., 2011; Inal & Kelleci, 2012).

Cobb and Cohen (2009) also suggest that the overriding emotional and cognitive factors of an anticipated immunization might reduce the effectiveness of a physical intervention. This could explain the increased pain experienced by the older age group (4 to 7 years old), the more cognitively aware group. Perhaps the detailed discussion of the device immediately prior to the injection increased distress by drawing attention to the upcoming immunization. Using the vibrating device during the injection might have also made traditional distraction techniques more difficult to use, such as drawing attention away from the injection site by asking distracting questions.

This study had several strengths. First, it was a randomized control trial, the gold standard of research. Subjects were diverse, being drawn from two clinical sites, including a free immunization clinic as well as a private pediatric clinic, which provides vaccinations to privately insured patients as well as state funded vaccinations to low income patients. The vibration device was also tested in clinical environments in which it would have the most potential to be used in the real world.

Several limitations to this study exist. First, blinding of the researchers was not possible because the vibration therapy was both visually and audibly apparent, potentially creating bias in scoring of pain, although the inter-rater reliability was good. Because of the young age of the children, the subjective FLACC pain score, rather than a self-reported verbalized pain score, was also used. Therefore, the FLACC score measures each nurse's perception of the patient's pain, rather than pain itself, and this proxy may contain error in measurement. Another limitation is variability in the types of immunizations given to each child. Some children received a different number of vaccines, more painful vaccines, and depending on whether or not the vaccine was given intramuscularly or subcutaneously, deeper vaccines. Therefore, even though the randomization led to an even distribution of high and low pain vaccination between control and intervention, there was no randomization to the types of vaccinations received.

Another important limitation is that two clinical sites were used, with 10 nurses participating. Different immunization administration techniques existed between the clinics. For example, at the immunization clinic, two nurses administered immunizations simultaneously, while at the private clinic, one nurse only tended to give the vaccines. There was also variance between the nurses' administration technique (for example, some nurses were quicker or used more verbal distraction). The final limitation is that the nurse administering the vaccine was also asked to assess pain, which could be difficult to assess while simultaneously administrating the vaccine, especially since the nurses had varying familiarity with the FLACC Scale (even though inter-rater reliability was high).

Further research is recommended on pain reduction techniques with childhood immunizations. New research might focus on a specific type of vaccination, such as influenza, to avoid the varying pain levels inherent with different vaccinations. A study that includes more research sites and a larger sample size would probably capture a more diverse patient population while still retaining the power to detect potential effects of the therapy. Including an older population with individuals who could assess their own pain would provide an actual measure of pain from the person experiencing the pain. Additionally, a cardio-respiratory monitor could be used to record heart and respiratory rates, providing an objective measure of distress or pain. It might be helpful to have additional staff so that the nurse assessing the FLACC score was not also responsible, and therefore, distracted by having to simultaneously administer the injection. Another option would be to videotape each injection, which allows the same people to assess pain, potentially improving interrater reliability. It would also allow more careful review of the data, as well as provide objective measurements of pain (crying time, for instance). Finally, while finding one device for children of all ages would be ideal, it may be unrealistic to search for a universal modality for pain control. Future research may need to focus on distinct treatment modalities for different age groups and developmental stages.

Conclusion

Given the wide, routine, and ever growing use of immunizations in the United States and elsewhere, practitioners have the opportunity to drastically improve the comfort of children receiving immunizations by learning pain prevention strategies. Improving the immunization experience for children, caregivers, and practitioners not only helps with the immediate experience, but it also has the possibility of improving adherence to vaccination schedules (Taddio et al., 2009) and optimizing clinical practices by promotion of health and prevention of infectious diseases.

References

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Taddio, A., Ilersich, A.L., Ipp, M., Kikuta, A., & Shah, V. (2009). Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations: Systematic review of randomized controlled trials and quasi-randomized controlled trials. Clinical Therapeutics, 31(Suppl. 2), S48-S76.

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Arika L. Benjamin, RN, is a Family Nurse Practitioner, School of Nursing, University of Alaska--Anchorage, Anchorage AK.

Thomas J. Hendrix, PhD, RN, is an Associate Professor, School of Nursing, University of Alaska--Anchorage, Anchorage AK.

Jacque L. Woody, MSN, RN, is an Assistant Professor, School of Nursing, University of Alaska-Anchorage, Anchorage AK.

Editor's Note: See page 130 at the end of this article for comments regarding the effectiveness of the Buzzy[R] device when used following the manufacturer's recommendations.
Table 1.
Chi-Square Comparison of Demographic Characteristics by
Intervention Assignment

                           Physical
                           Vibration   Control
                           (n = 50)    (n = 50)

Characteristics             N     %     N     %    p-Value

Age groups
  2 months to [less than   20    40    18    36
    or equal to] 1 year
  > 1 to s 4 years old     19    38    20    40
  > 4 to 7 years old       11    22    12    24     0.92
Vaccine type
  High pain                13    26    16    32
  Low pain                 37    74    34    68     0.51
Sex
  Boys                     26    52    26    52
  Girls                    24    48    24    48     0.76

Table 2
t-Test Comparisons of Difference in Pain Scores between Those
Receiving Physical Vibration to Those Receiving Standard
Immunization Techniques

                                                     Physical
                                                     Vibration
                                                     (n = 50)

           Pain Score Difference                 M       SE

Pre-Injection/Injection
  Overall                                      5.190    0.433
Age groups
  2 months to [less than or equal to] 1 year   6.825    0.504
  > 1 to [less than or equal to] 4 years old   4.079    0.588
  > 4 to 7 years old                           4.136    1.185
Vaccine type
  High pain                                    6.014    0.448
  Low pain                                     2.846    0.778
Pre-Injection/Post-Injection
  Overall                                      1.730    0.435
Age groups
  2 months to [less than or equal to] 1 year   1.750    0.572
  > 1 to [less than or equal to] 4 years old   1.368    0.701
  > 4 to 7 years old                           2.318    1.227
Vaccine type
  High pain                                    2.041    0.560
  Low pain                                     0.846    0.461
Injection/Post-Injection
  Overall                                     -3.460    0.404
Age groups
  2 months to [less than or equal to] 1 year  -5.075    0.665
  >1 to [less than or equal to] 4 years old   -2.711    0.503
  4 to 7 years old                            -1.818    0.692
Vaccine type
  High pain                                   -3.973    0.480
  Low pain                                    -2.000    0.597

                                                     Control
                                                     (n = 50)

           Pain Score Difference                 M       SE     p-Value

Pre-Injection/Injection
  Overall                                      4.980    0.451    0.737
Age groups
  2 months to [less than or equal to] 1 year   6.778    0.495    0.947
  > 1 to [less than or equal to] 4 years old   5.550    0.673    0.110
  > 4 to 7 years old                           1.333    0.445    0.046
Vaccine type
  High pain                                    5.853    0.534    0.818
  Low pain                                     3.125    0.635    0.781
Pre-Injection/Post-Injection
  Overall                                      1.510    0.348    0.694
Age groups
  2 months to [less than or equal to] 1 year   2.528    0.644    0.371
  > 1 to [less than or equal to] 4 years old   1.625    0.543    0.773
  > 4 to 7 years old                          -0.208    0.168    0.067
Vaccine type
  High pain                                    2.074    0.458    0.964
  Low pain                                     0.313    0.338    0.349
Injection/Post-Injection
  Overall                                     -3.470    0.413    0.986
Age groups
  2 months to [less than or equal to] 1 year  -4.250    0.512    0.340
  >1 to [less than or equal to] 4 years old   -3.925    0.784    0.206
  4 to 7 years old                            -1.542    0.585    0.762
Vaccine type
  High pain                                   -3.780    0.534    0.788
  Low pain                                    -2.813    0.609    0.356
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Article Details
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Author:Benjamin, Arika L.; Hendrix, Thomas J.; Woody, Jacque L.
Publication:Pediatric Nursing
Article Type:Report
Geographic Code:1U9AK
Date:May 1, 2016
Words:5592
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