Effectiveness of Music Therapy for Alleviating Pain During Shunt Punctures for Patients Undergoing Haemodialysis: A Multi-facility, Single-blind, Randomised Controlled Trial

Background Repeated pain during shunt vessel punctures is a serious problem for haemodialysis patients, even when prescribed external analgesics. While some studies have observed the efficacy of music therapy for improving pain and anxiety, its effectiveness during vessel punctures during dialysis is uncertain. The purpose of this study is to investigate the effects of music therapy for pain when cannulating a shunt blood vessel for haemodialysis patients. Methods A prospective, multi-facility, single-blind, crossover, randomised controlled trial will be implemented. The intervention includes listening to Mozart, along with a white noise control condition. One hundred twenty haemodialysis patients will be enrolled across five facilities. Patients will be randomly allocated to either an Early-sequence group or a Later-sequence group. The Early-sequence group will receive puncture while listening to Mozart’s Sonata for 2 pianos in D major (K.448) during the second week (Music period) and white noise during the fourth week (White noise period). The Later-sequence group will receive puncture along with white noise first, followed by Mozart. All patients will also undergo puncture during a ‘no-sound period (only wearing headphones) during the first and third week (No-sound period). The music or no-music protocol will begin 8 minutes prior to the puncturing procedure, and participants will finish listening after starting haemodialysis during each period. The primary outcomes that will be assessed include the Visual Analogue Scale (VAS) score for pain during puncture, and secondary outcomes such as blood pressure, heart rate, VAS anxiety score, State-Trait Anxiety Inventory score, and salivary amylase activity. The operator will be blind to each listening condition and VAS report. Discussion The proposed study has several methodological benefits. First, using white noise is a suitable control condition for addressing the role of sound on pain management. Additionally, using a crossover design with repeated measurements can help control individual differences between participants, which should better distinguish between- and within-participant variability. Overall, music therapy is a safe and inexpensive intervention that does not have the problematic side effects typically associated with pharmacological treatment. If effective, music therapy can be easily implemented for reducing pain and anxiety during cannulation.