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: • The benefits of music on pain and anxiety are well known and have been tested during different painful procedures. • The effect of active production of music has never been tested in children during venipuncture. WHAT IS NEW: • 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.

Distraction Using Buzzy or Handheld Computers During Venipuncture.

OBJECTIVES: Venipuncture is one of the most frequently performed painful procedures in children. The aim of this study was to investigate the effectiveness of 2 analgesic strategies for venipuncture in children in a specific setting like a blood-drawing center. METHODS: This was a prospective randomized controlled trial. It was conducted in the blood-drawing center of a tertiary level children's hospital in Italy, between November 2014 and February 2015. Eligible patients were children aged from 4 to 12 years referred to the blood-drawing center for venipuncture. Enrolled children were randomized to be distracted by Buzzy device or by playing with a handheld computer. The procedural pain was measured with the faces pain scale-revised by children aged from 4 to 7 years and with a numerical rating scale by children aged from 8 to 12 years. RESULTS: Two hundred children with a median age of 8 years were enrolled in the study. The self-reported procedural pain was not statistically different between the Buzzy group and the handheld computer group: median (interquartile range) = 3.0 (1.0-4.8) and 2.0 (1.0-4.8), respectively (P = 0.72). Children reported significant pain in 25% of cases with both distraction strategies. The procedural success rate at the first attempt was not significantly different in the 2 groups. CONCLUSIONS: Analgesia provided by Buzzy or by a handheld computer was not significantly different in children undergoing venipuncture in a blood-drawing center, with the great proportion of them reporting no or mild pain during procedure.

Hand-held computers can help to distract children undergoing painful venipuncture procedures.

AIM: Needle-related procedures can be painful for children, and distraction provides ideal pain relief in blood-drawing centres. This study assessed the effectiveness of playing a computer game during venipuncture, compared with low-tech distraction by a nurse. METHODS: We conducted this prospective, randomised controlled trial at the blood-drawing centre of a tertiary-level children's hospital in Italy. Half of the 200 children played Angry Birds on a hand-held computer while the other half were distracted by a second, specifically trained nurse who sang to them, read a book, blew bubbles or played with puppets. Pain was measured using a faces pain scale for children aged 4-7 years and a numeric scale for children aged 8-13 years. RESULTS: The 200 children had a median age of eight years. Children reported significant pain in 16 cases (16%) in the hand-held computer distraction group and in 15 cases (15%) in the nurse-led low-tech distraction group (p = 0.85). The procedural success rate at the first attempt was not different in the two groups. CONCLUSION: Playing a game on a hand-held computer meant that only one in six children reported pain during venipuncture, but it was not superior to being distracted by nurses.