Division of Nephrology, National Cerebral and Cardiovascular Center, 6-1 Kishibeshinmachi, Suita, 564-8565, Japan.
Department of Nephrology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, 390-8621, Japan.
Trials. 2019 Nov 19;20(1):631. doi: 10.1186/s13063-019-3773-x.
Repeated pain during haemodialysis access cannulations is a serious problem for haemodialysis patients even when prescribed oral or topical analgesics. Although some studies have observed the efficacy of music therapy for improving pain and anxiety, its effectiveness during haemodialysis access cannulations during dialysis is uncertain. The purpose of this study is to investigate the effects of music therapy for pain when cannulating haemodialysis access for haemodialysis patients.
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 cannulation while listening to Mozart's Sonata for two 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 cannulation along with white noise first, followed by Mozart. All patients will also undergo cannulation during a no-sound period (wearing only headphones) during the first and third week (No-sound period). The music or no-music protocol will begin 8 min prior to the cannulating 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 cannulation, and secondary outcomes are blood pressure, heart rate, VAS anxiety score, State-Trait Anxiety Inventory score, and salivary amylase activity. The operators who are in charge of haemodialysis access cannulation will be blind to the listening condition and VAS report.
The proposed study has several methodological benefits. First, using white noise is a suitable control condition for addressing the role of sound in 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.
This trial was prospectively registered to UMIN Clinical Trials Registry on 1 July 2018 (UMIN 000032850).
即使给血液透析患者开了口服或局部止痛药，在进行血液透析通路插管时反复出现疼痛仍是一个严重的问题。虽然一些研究观察到音乐疗法可以改善疼痛和焦虑，但它在透析期间血液透析通路插管时的效果尚不确定。本研究旨在探讨音乐疗法在血液透析患者进行血液透析通路插管时缓解疼痛的效果。
将实施一项前瞻性、多中心、单盲、交叉、随机对照试验。干预措施包括听莫扎特的音乐和白噪声对照条件。将在 5 个机构中招募 120 名血液透析患者。患者将被随机分配到早期序列组或晚期序列组。早期序列组将在第二周（音乐期）听莫扎特的《为两架钢琴而作的 D 大调奏鸣曲》（K.448）的同时接受插管，而在第四周（白噪声期）接受白噪声。晚期序列组将先接受插管，然后听白噪声，然后再听莫扎特。所有患者还将在第一和第三周（无声期）佩戴耳机时接受无声音插管。音乐或无声方案将在插管程序开始前 8 分钟开始，并且在每个周期开始进行血液透析后，参与者将完成收听。主要结局评估指标包括插管过程中疼痛的视觉模拟量表（VAS）评分，次要结局评估指标包括血压、心率、VAS 焦虑评分、状态-特质焦虑量表评分和唾液淀粉酶活性。负责血液透析通路插管的操作人员对听力条件和 VAS 报告将保持盲态。
拟议的研究具有几个方法学上的优势。首先，使用白噪声是解决声音在疼痛管理中作用的合适对照条件。此外，使用交叉设计和重复测量可以帮助控制参与者之间的个体差异，这应该可以更好地区分个体间和个体内的变异性。总的来说，音乐疗法是一种安全且廉价的干预措施，不会产生通常与药物治疗相关的有问题的副作用。如果有效，音乐疗法可以很容易地实施，以减轻插管过程中的疼痛和焦虑。
该试验于 2018 年 7 月 1 日前瞻性地在 UMIN 临床试验注册处注册（UMIN 000032850）。
