Quality of Studies and Risk of Bias
Table 3 shows the results for the risk of bias assessment for critically important outcomes. All trials had a high overall risk of bias primarily due to lack of blinding of important personnel, outcome assessors (eg, participants, immunizers), or both, and unclear allocation concealment.
Overall Quality of Evidence and Treatment Effects
A quantitative summary of the treatment effects for available critically important outcomes is provided below. Table 4 displays a qualitative summary of these results. In addition, GRADE evidence profiles and summary of findings tables (Tables, Supplemental Digital Contents 1 to 4, http://links.lww.com/CJP/A217, http://links.lww.com/CJP/A218, http://links.lww.com/CJP/A219, http://links.lww.com/CJP/A220) and accompanying forest plots (Figures, Supplemental Digital Contents 1 to 4, http://links.lww.com/CJP/A221, http://links.lww.com/CJP/A222, http://links.lww.com/CJP/A223, http://links.lww.com/CJP/A224) for critically important and important outcomes are included as Supplemental Digital Contents.
Should a Verbal Signal of the Impending Procedure be Used (Rather Than Signal of Impending Pain) by Clinicians During Vaccine Injections in Individuals of All Ages?
Three trials including 402 adults investigated the impact of signaling about the start of the procedure as compared with signaling about the impending pain during venous cannulation19 or venipuncture.22,24 There was very low quality of evidence because of high risk of bias and imprecision for all outcomes (Table, Supplemental Digital Content 1, http://links.lww.com/CJP/A217). All 3 studies measured self-reported pain intensity (n=391), and there was no evidence of a benefit for individuals who received a signal about the start of the procedure compared with those who received a signal about the impending pain: SMD=−0.60 (95% CI, −1.37, 0.16) (Figure, Supplemental Digital Content 1, http://links.lww.com/CJP/A221). However, participants in 1 study24 reported significantly lower self-reported pain intensity than in the other 2 included studies. When data from this study was removed, a significant difference was observed in pain, with participants who received the signal about the impending procedure reporting significantly lower pain as compared with those who received the signal about the impending pain (n=199): SMD=−0.97 (95% CI, −1.26, −0.68). Two studies22,24 examined whether the patient reported that they experienced pain or no pain during the procedure (ie, a score of ≥1 on a numerical rating scale22 or a rating of “no pain” on a verbal response scale24). No difference in whether pain was present or absent was observed based on the type of signal provided (n=290): relative risk=0.29 (95% CI, 0.01, 5.83).
Should Music Distraction be Used During Vaccine Injections in Adults?
Two trials including 156 adults investigated the effect of listening to music as distraction.20,21 Included studies compared listening to preferred music selected from a variety of musical selections on headphones during venous cannulation compared with a control group (no intervention). Music distraction was not associated with lower pain (n=156): SMD=−0.10 (95% CI, −0.48, 0.27), or fear (n=156): SMD=−0.25 (95% CI, −0.61, 0.10), when compared with a control group (Figure, Supplemental Digital Content 2, http://links.lww.com/CJP/A222). There was very low-quality evidence for critically important outcomes of pain and fear (Table, Supplemental Digital Content 2, http://links.lww.com/CJP/A218).
Should Visual Distraction be Used During Vaccine Injections in Adults?
Two trials including 177 adults investigated the effect of using kaleidoscopes as visual forms of distraction.17,21 Included studies compared looking through the eyepiece of a kaleidoscope during a needle procedure (either venous cannulation21 or venipuncture17) to a control group (no intervention). Both studies examined the critically important outcome of pain, with no benefit of visual distraction with a kaleidoscope for pain (n=177): SMD=−0.57 (95% CI, −1.82, 0.68) (Figure, Supplemental Digital Content 3, http://links.lww.com/CJP/A223). There was very low-quality evidence for pain, a critical outcome (Table, Supplemental Digital Content 3, http://links.lww.com/CJP/A219). One study21 also examined the critically important outcome of fear, with no benefit of visual distraction with a kaleidoscope (n=81): SMD=−0.05 (95% CI, −0.50, 0.40), also with very low quality of evidence.
Should Breathing Interventions (Cough, Breath-Hold) be Used During Vaccine Injections in Adults?
Two trial including 138 adults compared breathing interventions to a control group (no intervention) during venipuncture. This included the “cough trick” (a modification of acupuncture techniques that involves coughing twice, without moving the arms, with the venous cannulation being performed on the second cough23) and the Valsalva maneuver (a deep inhale, followed by a forceful holding of the breath during which the venous cannulation insertion occurs18). Less pain was observed for the breathing interventions: SMD=−0.82 (95% CI, −1.21, −0.43) (Figure, Supplemental Digital Content 4, http://links.lww.com/CJP/A224). The quality of the evidence was very low (Table, Supplemental Digital Content 4, http://links.lww.com/CJP/A220).
This systematic review was undertaken to determine the effectiveness of simple psychological interventions that can be employed to reduce pain and fear related to vaccine injections in adults. As the literature review did not identify any studies on simple psychological interventions for adults undergoing vaccinations, our synthesis included indirect evidence from other common needle procedures (ie, venipuncture or venous cannulation). There was some evidence for the use of breathing interventions (cough trick, Valsalva maneuver) for reducing pain during venipuncture. There was evidence of an effect of signaling about the procedure (without reference to pain or discomfort) as compared with signaling about the impending pain in studies where participants reported higher levels of pain. There was no evidence for music or visual distraction.
Although the studies examining breathing interventions suggested that the interventions may have provided a distraction to participants while the needle procedure was being completed, physiological mechanisms for treatment benefit are also possible. Usichenko et al23 suggested that the increased pressure in the subarachnoidal space induced by coughing may activate pain inhibition pathways. Basanranoglu et al18 provided a similar physiological explanation for the efficacy of the Valsalva maneuver, describing that the action stimulates the vagus nerve, which is involved in the modulation of the pain experience. The impact of breathing interventions on reducing adult procedural pain was observed across both types of breathing interventions, and despite differences in population and methodology in both studies: one study was a cross-over study comprised of only men and using the cough trick,23 whereas the other study was parallel comprised of only women comparing the Valsalva maneuver to a no-treatment control group.18 Overall, the mechanisms of treatment benefit from these breathing interventions remain unclear. These results differ to those found in the companion review of psychological interventions for vaccination pain management in children,10 which found no benefit of coughing for pain. The study of children identified numerous barriers to the implementation of the cough trick in the clinical setting (eg, children refusing to cough to delay the injection), which may have accounted for some of the differences between the findings for adults and children.33 As these findings are limited to only 2 trials, and support the efficacy of this intervention, additional trials of these breathing interventions for the adult vaccination setting is warranted.
Given the documented impact of health care provider and caregiver verbalizations on anxiety and pain experienced by adults and children during painful medical procedures,34,35 examining how health providers interact with patients during painful procedures is of great importance. When all 3 studies were combined in the meta-analysis, no effect of signal type on pain was observed, however, when 1 study which had participants with significantly lower pain scores was removed, signaling about the start of the procedure was associated with significantly lower pain scores than signaling about the impending pain. This suggests that this intervention may be more important for those who report higher levels of pain. Of note, there was wide variability in verbal instructions provided to participants across the 3 included studies. Although each study involved a condition in which participants were signaled about the impending procedure and a condition in which participants were signaled about the impending pain, they differed on a number of potentially important characteristics, including language of delivery (English, German), the extent to which the instructions drew attention to nonpain physical sensations in the arm, and the exact words used to describe the impending pain and procedure (eg, “scratch” and “sting” describe different physical sensations; “beware” may signal threat, while “ready” may convey a sense of control; each of these words perhaps evoking different expectancies which may influence the pain response36–38). In addition, previous research in children has suggested that vocal tone may impact the interpretation of statements provided during a painful procedure.35 Future research may benefit from examining not only the content of the statements provided to adults before needle procedures, but also the tone and quality in which the statements are delivered. Increasing the threat value of pain through the use of pain-related threatening words and descriptions increases catastrophizing and decreases tolerance of pain,39,40 and may reduce the efficacy of other interventions, such as distraction.41–44 Overall, given the variability in the included studies, and the experimental evidence that verbal statements can decrease pain, more research into this intervention is clearly needed.
The evidence was insufficient to support the use of music or visual distraction (ie, looking through a kaleidoscope) for the management of procedural pain and fear in adults. Distraction has been hypothesized to relieve procedural pain by actively drawing the patient’s finite attentional resources away from the pain,45 with music in particular being described as having the added benefit of inducing different emotional states.46 Although distraction has consistently been shown to reduce pain and distress during childhood vaccination,5,10 the use of distraction with adults has been a controversial subject in health psychology.47 A Cochrane review of the use of music for pain management has described the effects of music as being so small that they should not be a first-line choice of treatment, with music showing no effect on procedural pain.48 The results of the present review reflect previous findings in adult populations suggesting that distraction is not effective for the relief of procedural pain. In particular, findings of the present study are in line with what was reported in a head-to-head trial by Taddio et al,27 where it was found that self-directed distraction was less effective than liposomal lidocaine, providing support for the generalizability of the present finding to a vaccination context.
Previous research investigating the use of distraction in adult oncology patients described that some patients reported that they found the distraction interventions bothersome and intrusive in their attempts to attend to the procedure being performed.49 Individual differences, such as the desire to attend or not attend to a medical procedure, may impact an individual’s ability to engage with a distraction.50 As the studies involved in the present review did not measure engagement of the individual with the distractor, it is difficult to draw any conclusions regarding how effectively the distractor managed to capture the attention of the participants.51 This is an important area for future research and may inform treatment-tailoring efforts to maximize benefit to individuals.
A major limitation of the findings from this knowledge synthesis is that none of the included trials specifically examined vaccinations. As no studies involving vaccination were eligible for inclusion, related procedures, contexts (eg, venipuncture), or both were examined instead. There are numerous factors that differentiate the vaccination context from other needle procedures, which should be taken into consideration when extrapolating results to the vaccination setting. The lack of empirical evaluation of psychological interventions for vaccination pain in adults may reflect the belief that adults should be capable of coping with commonly experienced injections without the need for intervention. In addition, the present review only focused on simple psychological interventions, to prioritize interventions that are feasible, as well as time and cost efficient, to implement. However, for adults who require frequent needle procedures or who experience greater needle anxiety, more complex and longer interventions such as functional relaxation,25 or exposure-based interventions (also McMurtry CM, Taddio A, Noel M, et al., unpublished data, 2015),11 may be warranted. No research to date has synthesized the literature on complex psychological interventions for needle pain management.
The risk of bias was high for all included trials; in all cases blinding of participants or personnel was not performed, and blinding of outcome assessment was rarely employed. In addition, there was considerable heterogeneity in the included studies with regards to population and methodology. For example, several studies included successful and nonsuccessful procedures,20,21 whereas others only included successful first attempts.17,18,23,24 Many studies excluded participants if there were any factors involved that would make the needle procedure more difficult or painful than usual (eg, participants with a history of difficult venous access19), which limits the generalizability of the present findings to populations that may be at higher risk of experiencing pain during vaccination. With regards to the clinical relevance of the present research, it is important to also consider the role that fear may have in the efficacy and patient’s ability to engage in psychological interventions for needle pain, given the high prevalence of needle fears in the general population (also McMurtry CM, Taddio A, Noel M, et al., unpublished data, 2015).11,52 It is possible that individuals who agreed to participate in research involving needle procedures, particularly in those studies that involved healthy volunteers, may have a particularly low level of needle-related fear. In addition, some samples excluded individuals who reported fear of pain or blood draws,22 or participants who were crying or showing other overt signs of distress at the time of the procedure,17 which reduced the likelihood that individuals with higher needle fears would have been captured in the populations of the present review. This is of particular relevance given that needle fears are common in adults.3 The level of needle fear should be considered when determining the appropriateness of an intervention, as individuals with higher pain-related fear have demonstrated an attentional bias toward pain-related stimuli and as such may be more attuned to the specific language used by providers before the procedure.53 In addition, previous research has found that individuals with high pain-related fear benefit less from distraction, and may in fact derive greater benefit from a sensory-focused intervention instead.42
The present review only examined simple psychological interventions. This resulted in a synthesis of data that is relevant for health care providers that perform needle procedures (ie, the information is clinically relevant), and describes the efficacy of interventions that are time and cost effective to deliver. A rigorous approach to the analysis was used, guided by both GRADE and Cochrane methodologies. Other aspects of the methodological approach used in this systematic review14 and other related systematic reviews in this series are reviewed separately, as are limitations and future directions of this larger body of work by the HELPinKids&Adults Team.54 In light of current concerns about vaccine hesitancy across the lifespan,55 our review identifies a considerable need for future empirical work in the area of psychological interventions for procedure pain management in adults.
In conclusion, there is support for the use of breathing interventions for reducing pain during adult venipuncture and venous cannulation. There is evidence for providing a signal about the impending procedure for individuals who report experiencing higher levels of pain. There is no evidence of a benefit of music or visual distraction. This paper makes an important contribution as it provides the first synthesis of available evidence on psychological interventions for use with adults undergoing needle procedures. Our review provides insight into developmental differences in efficacy of these interventions relative to adolescents and children. More research is needed to explore the role of psychological interventions for vaccine pain management in adults.
The authors thank Dr Jennifer A. Parker, PhD, Research Associate, Centre for Pediatric Pain Research, IWK Health Centre; Adjunct Professor, Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia for her contributions to this work.
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pain management; randomized controlled trial; systematic review; psychological; needle pain
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