Quality of Studies and Risk of Bias
Table 3 shows the results for the risk of bias assessment for critical outcomes. All trials had a high overall risk of bias primarily due to lack of blinding of important personnel and lack of methodological rigor in relation to randomization procedures.
Overall Quality of Evidence and Treatment Effects
A quantitative summary of the treatment effects for available critical outcomes is provided below. Table 4 displays a qualitative summary of these results. Supporting GRADE Evidence Profiles and Summary of Findings tables for critically important and important outcomes is in the Supplemental Digital Content for this paper (Process Figs. 1 to 5, Supplemental Digital Content 1, http://links.lww.com/CJP/A280 and Process Tables 1 to 5, Supplemental Digital Content 2, http://links.lww.com/CJP/A281).
Should Clinicians Administering Vaccine Injections be Educated About Vaccine Injection Pain and Fear Management?
One trial examined the efficacy of training public health nurses (n=53) who were immunizing children of all ages on a variety of evidence-based pain management strategies.21 There was low-quality evidence due to methodological limitations related to randomization details and lack of blinding of both participants and outcome assessors. The trial addressed the critical outcome of use of interventions and results were in favor of clinician education (n=459; SMD 0.66; 95% CI: 0.47, 0.85).
Should Parents be Present During Vaccine Injections in Children?
Four trials addressed the presence of parents during childhood vaccine injections,22–24,33 with 1 trial33 providing 2 arms as data were presented separately for toddlers (approximately 18 mo of age) and preschoolers (approximately 5 y of age). Only 3 trials23,24,33 provided data on a critical outcome (distress: preprocedure, acute, recovery, preprocedure+acute+recovery) and all analyses were based on very low-quality data due to lack of blinding, selective data reporting, and small sample sizes. The results were mixed; data only supported the presence of parents for distress preprocedure (n=67; SMD −0.85; 95% CI: −1.35, −0.35).
Should Parents be Educated About Vaccine Injection Pain and Fear Management Ahead of Time?
Five25–29 trials studied the efficacy of parent pain management before the day of vaccination. All trials were performed in the context of vaccinations of children 2 years or below, only 425,27–29 of the trials provided data for the analysis of critical outcomes (use of intervention and distress). In regards to the critical outcome for parent use of intervention, 3 separate analyses had to be conducted due to the timing of the measurement or the type of data provided. Parent use of pain management strategies before the procedure was supported by data from 1 trial25 of low quality (n=50; SMD 0.83; 95% CI: 0.25, 1.41). During the procedure, parent use of interventions using continuous data from 1 moderate quality trial27 did not support parent education, whereas a categorical analysis of 2 trials28,29 of low quality did support advance education in improving parent use of pain management strategies (n=300; RR 2.08; 95% CI: 1.51, 2.86).
Analyses on the critical outcome of distress were conducted on the acute and the acute+recovery phases using low-quality data. Results were mixed as only data on the acute distress outcome, based on 3 trials,25,28,29 supported educating parents in advance of education (n=350; SMD −0.35; 95% CI: −0.57, −0.13).
Should Parents be Educated About Vaccine Injection Pain and Fear Management on the Day of Vaccination?
Four trials were reviewed for this clinical question,26,28,30,31 with 1 study providing 2 separate arms for analysis26 of critical outcomes. The quality of the evidence was low to very low, primarily due to issues, omissions related to randomization procedures, or both and the lack of blinding of participants and personnel. For the critical outcome parent use of intervention, both continuous data analysis26,30 (n=183; SMD 1.02; 95% CI: 0.22, 1.83) and categorical data analysis28,31 (n=239; RR 2.42; 95% CI: 1.47, 3.99) supported the education of parents on the day of vaccination. Because of the age of children in the analyses (6 and below), distress was considered (ie, acute, acute+recovery, preprocedure+acute+recovery, and preprocedure distress). Results were mixed. Only the analysis on the preprocedure+acute+recovery distress outcome supported parent education on the day of vaccination (n=262; SMD −0.48; 95% CI: −0.82, −0.15).
Should Children Above 3 Years and Adults be Educated About Vaccine Injection Pain Management on the Day of Vaccination?
One very low-quality study (n=17) contributed 2 arms to the analysis of the critical outcome of fear32 (preprocedure, postprocedure) based on children 11 to 12 years of age. Analyses showed mixed support for the reduction of fear through education of patients on the day of immunization: fear preprocedure (SMD −0.67; 95% CI: −1.28, −0.07) and fear postprocedure (SMD −0.63; 95% CI: −1.62, 0.36).
This systematic review examined education strategies for clinicians, parents (before the day of vaccination, on the day of vaccination), and individuals being vaccinated (on the day of vaccination), in addition to an analysis of instructing a parent to be present or absent during the vaccination procedure. The results demonstrated evidence to support educating all groups (both in advance and on day of vaccination) and the parents present; however, the results were mixed for the majority of analyses. A discussion of each clinical question in turn will expand on these findings.
One low-quality trial21 provided evidence that an education intervention (2-hour workshop on evidence-based pain management; online support) was able to increase nurse pain management strategy utilization. These effects were seen both in comparison with the no education group and in comparison with their own strategy utilization during the baseline phase. Although there was a large number of patients exposed to increased evidence-based pain management (n=459) in this study, the actual number of nurses in the trial was quite small (n=53). Nonetheless the uptake of pain management was significantly increased and the cost-benefit ratio was favorable. These results, coupled with the expectation that immunizing clinicians who are competent in vaccination administration techniques, including ways to prevent pain (ie, adverse events or harm), supports the notion that clinicians should be educated about these strategies. This study was conducted with nurses who were already practicing. Another important future direction will be to explore the specific benefits of providing pain management education during health professional training, through nursing and medical schools, with continuing education modules available after graduation. In addition, the paucity of trial data for this integral strategy suggest the need for more research.
Although there were more data for the education of parents, results were mixed for both educating parents before vaccination day and on the vaccination day for both critical outcomes where data were available (increase in use of strategies, distress). The only analysis of moderate quality27 in the meta-analyses suggested that parent use of strategies did not increase with education before the immunization day, whereas 2 other separate analyses of use of strategies (based on trials of lower quality25,28,29) suggested prior parent education was efficacious. This difference was hypothesized to have been due to the format of the education. Specifically, the trial27 that did not find significant effects educated parents through inclusion of a pamphlet in a postnatal information package when mothers left the hospital, whereas the other interventions involved interactive discussion, presentations, or both videos, information pamphlets, or both. Thus, educational efforts likely need to be more interactive rather than simply providing a brochure.13 All of the analyses on educating parents on the vaccination day (very low to low quality) suggested an increase in parent use of pain management strategies. In terms of the impact of educating parents on the critical outcome of distress, mixed results were found for both prior and on-the-day-of education of parents. There was no apparent pattern to the findings but again, the heterogeneity of the interventions that were synthesized likely contributed to these mixed findings.
The mode of education used to teach parents included usual modalities, such as pamphlets, videos or computer-based education, and in person education. Prior work suggests that parents are accepting of these methods of instruction; in fact, video instruction has been reported as being particularly helpful in increasing their knowledge about how to implement pain strategies.34 Little attention, however, has been given to individualizing education according to personal preference. None of the trials synthesized asked the parent for a preferred mode of education or preparation. This is an important factor in education and should be included in future studies. Moreover, the dominance of smart phone technology and app-based education tools, provide other novel and potentially engaging instructional formats that need to be empirically studied.
Another important consideration in targeting parents for education is the perception of parents regarding their role in mitigating pain and the support afforded to them by health care providers. In previous studies, it has been demonstrated that parents often look to health care providers to endorse and lead pain management efforts.35,36 Even if parents actively seek advice and advocate for pain management, some clinicians may refuse to allow pain interventions.27,28 This will likely lead to a more distressing procedure for children and a more negative experience for parents who are now aware that something could have been done to make their children more comfortable but was not. More generally, it may also lead parents to question the competence of their clinician. Conversely, messages and actions by clinicians that “dismiss” pain may falsely lead parents to believe that managing pain is unimportant, which puts children at risk for the adverse sequelae of pain (ie, development of needle fears and health care avoidance behaviors).37 Any efforts to educate parents should also target clinicians administering vaccinations.
The education of individuals being vaccinated was based on very low-quality data with children. Although the analysis on the 1 trial implementing education on the day of vaccination32 supported efficacy for the critical outcome of fear, there were no data on increased use of strategies nor on pain. More research needs to be done across the lifespan that examines different modes of education and how they interact with individual preferences. The effects of education before the vaccination day are particularly worthy of study, especially in children who have a higher level of fear of needles.37 In 1 before-and-after study that educated school-aged children about needles, a decrease in child self-reported fear of needles and an increase in willingness to be vaccinated were observed.4 The results of this study suggest that these interventions hold promise for reducing future pain and improving vaccination compliance among this vulnerable group. Prior education also affords individuals with additional time to learn about how to implement interventions and reduces the potential for disappointment from not being able to optimally implement pain treatments of their choice (eg, topical anesthetics, which require prior purchase and time for application). Moreover, another important variable to consider in future trials is how far in advance to prepare and educate. It is clear that optimal timing will likely depend on both developmental and personality factors.
The remaining clinical question related to the presence of parents during vaccination injections.22–24,33 The results were mixed regarding the impact on child distress. In 3 of the 4 analyses (distress acute, distress, distress recovery, preprocedure+acute+recovery), results appeared to support parent absence rather than presence. Only for the distress preprocedure outcome did results support presence. This question was based on the lowest quality of evidence due to issues with randomization, blinding, and selective outcome reporting. Together, the results suggest that in a lower distress situation (ie, in anticipation of a painful needle), parent presence seems to reduce distress. However, in a high distress situation (ie, after a painful needle), parent presence increases distress. Although at face value, this could be taken to suggest that parents should not attend vaccinations; consideration of additional factors is needed when interpreting the results. Firstly, children clearly report a strong preference for parental presence at vaccination.7,23 Children’s preferences should be taken into account when delivering vaccine injections. Secondly, from an attachment perspective, stronger pain signaling in the presence of parent is expected.38 A recent observational study of infant vaccination pain and infant attachment status showed that secure babies signaled more distress than insecure babies38 in the absence of any formalized pain management strategies. It is posited that the increased distress (in the absence of other formalized pain management strategies) reflects the attachment security of the infants. The patterns for expressing and regulating distress in the context of their caregiver represent a newly recognized source of distress variability in the infant vaccination context that should be considered in future studies.39 Despite the mixed evidence base, our group strongly recommends parent presence for young children below 10 years of age. This is due to the developmental needs (ie, attachment needs) that have been clearly demonstrated in young children during periods of distress. However, recommendations regarding the role of parent presence with older children cannot be discerned at this time. Research in this age group seems to be nonexistent (likely because older children are often involved in school-based immunization programs where parents are not present) and older children may have differing preferences (peer support may play a larger role in the social context of these immunizations during the adolescent stage of development). The value of parental presence also may vary according to the distress levels of the parent themselves. More research must be done to explore the role of parental presence across childhood according to important covariates such as age, parental psychopathology, or parental comfort in medical settings.
Some limitations to this review must be reviewed. The paucity of evidence and low quality of existing evidence provided a weak foundation on which to make definitive conclusions. Moreover, the heterogeneity of educational strategies that were analyzed together, the lack of attention to individual preferences (eg, how information is delivered, how much information is given, when the information is given), and individual variability factors (eg, attachment status) also suggests this particular area is in dire need of strong trials that take a more sophisticated approach to study design. Strengths of the review include a thorough database search for all relevant studies, a priori decisions for identifying relevant clinical questions and critically important outcomes, and the use of state-of-the-art methods for pooling data and evaluating the quality of evidence.
In conclusion, in the first analysis of process interventions for pain management during vaccination, we found evidence for educational interventions directed at clinicians, parents, and individuals undergoing immunization, and parent presence during childhood vaccination. Educational interventions empower all stakeholders to take control of the pain, fear, and distress that is known to occur in relation to vaccine injections. More work is recommended in this area to inform society about better ways to translate and mobilize pain management strategies.
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pain management; randomized controlled trial; systematic review; vaccination; parent presence; education; implementation science
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