Active production of music as distraction for venipuncture in children and adolescents: a randomized clinical trial

More than 50% of children report considerable pain during venipuncture or intravenous cannulation. Despite the tools and techniques may be employed to reduce pain and distress in everyday clinical practice, the care offered is frequently insufficient. Music's potential effect in healthcare settings has received increasing attention. This study aimed to verify if the active production of music with a Leap Motion Controller could help decreasing pain and distress during venipuncture in children and adolescents. We conducted an open-label randomized controlled clinical trial with parallel arms. Children aged 8 to 17 were enrolled at the blood-drawing center of the Institute for Maternal and Child Health IRCCS Burlo Garofolo of Trieste, Italy. We hypothesized that in order to demonstrate an adequate improvement in the pain score in the intervention group, at least 200 children, 100 in each group, were needed, with alpha 5% and 1-beta 80%. Differences between the groups were evaluated with the nonparametric Mann-Whitney U-test. The subjects were randomly assigned either to the active production of music group or to the standard of care group. The primary outcome was the median self-reported procedural pain score between experimental and standard of care group. Secondary outcomes were: the median pain and distress scores according to parental judgment and operators' judgment between the experimental and control group. Three hundred subjects entered the study and were randomized, 150 in the active production of music group and 150 in the standard of care group. Median self-reported pain scores were 1 (0-2) in the active production of music group and 2 (1-2) in the standard of care group and this difference was statistically significant (p = 0.0016). Median procedural distress was 1 (0-3) in the active production of music group and 3 (1-6) in the standard of care group, according to parental judgment, and this difference was statistically significant (p = 0.0000016).Conclusion: This research showed that the active production of music is a valuable distraction technique to decrease venipuncture related pain and distress in children and adolescents.Trial registration: The study protocol was registered with ClinicalTrial.gov (June 28[th] 2022, NCT05441241) before the start of the subjects' enrolment.What is Known:center dot The benefits of music on pain and anxiety are well known and have been tested during different painful procedures.center dot The effect of active production of music has never been tested in children during venipuncture.What is New:center dot In our study median self-reported pain scores and median procedural distress, according to parental judgment, were lower in the active production of music group than in the standard of care group and these differences were statistically significant.