Music Therapy to Reduce Anxiety and Pain in Chronic Pain Patients During Procedures

Официальное название

Effect of Peri-Operative Music Therapy on Anxiety, Pain Catastrophising, and Pain in Chronic Pain Patients Undergoing Interventional Pain Procedures - A Randomised Controlled Trial

Обзор

This study aims to find out whether listening to music before, during, and after pain procedures can help reduce anxiety, pain catastrophising, and acute pain in patients with chronic pain. Music therapy may provide a simple, safe, and non-drug way to help patients relax and feel more comfortable. In this study, adult patients with chronic pain who are scheduled for interventional pain procedures at Singapore General Hospital will be randomly assigned to one of two groups. One group will listen to self-selected music through headphones and speakers before, during, and after the procedure. The other group will receive standard care without music. Researchers will measure anxiety, pain catastrophising, and pain levels before and after the procedure using validated questionnaires. The main outcome will be the level of anxiety after the procedure. Other outcomes include pain catastrophising scores, pain scores during local anaesthetic injection, and overall patient satisfaction. This study will help determine if music therapy can be routinely used to improve comfort and emotional well-being for patients undergoing interventional pain procedures.

Подробное описание

This is a single-centre, randomised controlled trial conducted at the Singapore General Hospital Pain Management Centre. The study investigates whether peri-operative music therapy can reduce anxiety, pain catastrophising, and pain in patients with chronic pain undergoing interventional pain procedures in the ambulatory setting.

A total of 110 adult participants (aged 21 years and above) with chronic pain lasting at least 3 months and scheduled for interventional pain procedures will be enrolled. Participants will be randomised in a 1:1 ratio to either the music therapy group or the control group using a computer-generated block randomisation sequence with sealed opaque envelopes.

Intervention group: Participants will listen to self-selected music from curated playlists (including soothing, meditative, multilingual, and instrumental tracks) before, during, and after the procedure. Music will be played for 30 minutes pre-procedure via headphones, continued intra-procedurally via Bluetooth speaker to maintain communication, and resumed for 30 minutes post-procedure via headphones.

Control group: Participants will receive standard peri-procedural care without music exposure.

Due to the nature of the intervention, blinding of participants and proceduralists is not feasible. However, outcome assessors and statisticians will remain blinded to group allocation.

The primary endpoint is postoperative anxiety measured using the Visual Analogue Scale for Anxiety (VAS-A). Secondary endpoints include pain catastrophising scores (Pain Catastrophising Scale, PCS), procedural pain (Numerical Rating Scale, NRS), and patient satisfaction scores.

Data will be collected pre-procedure and immediately post-procedure. Baseline demographics, analgesic/sedative use, and intra-procedural variables (e.g., duration, complications, and rescue medication use) will also be recorded. Statistical analysis will compare mean differences between groups using independent t-tests for continuous variables and chi-square tests for categorical variables, with significance set at p \< 0.05.

The study is classified as minimal risk, involving a non-invasive behavioural intervention. No Data Monitoring Committee has been appointed. Oversight will be provided by the Principal Investigator and study mentor, with periodic internal data reviews.

This trial aims to provide evidence for a simple, low-cost, and patient-centred intervention that could enhance peri-procedural comfort and reduce psychological distress in chronic pain patients undergoing day surgery procedures.

Вмешательства

• Поведенческое Music Therapy
  This intervention consists of perioperative music therapy for patients with chronic pain undergoing interventional pain procedures in the ambulatory setting. Participants in the intervention group will listen to self-selected music for approximately 30 minutes before, during the procedure, and 30 minutes after their procedure. Music will be delivered via headphones pre- and post-procedure and via a Bluetooth speaker during the procedure to facilitate communication with the procedural team.

Первичные конечные точки

• Postoperative Anxiety (Visual Analogue Scale) [Срок оценки: Scores will be recorded before the procedure (baseline) and post-procedure within 30 minutes.]

Вторичные конечные точки (4)

• Pain Catastrophising Score [Срок оценки: This will be measured before the procedure (baseline) and post-procedure within 30 minutes.]
• Postoperative Anxiety (State-Trait Anxiety Inventory Short Form) [Срок оценки: This will be measured at baseline (pre-procedure) and post-procedure (within 30 minutes of completion).]
• Postoperative Pain Score [Срок оценки: Participants will rate their pain after the procedure in the recovery area (within 30 minutes).]
• Patient Satisfaction [Срок оценки: Within 30 minutes of the procedure.]

Критерии участия

Критерии включения

• aged ≥21years
• chronic pain ≥3 months
• scheduled for interventional pain procedures

Критерии исключения

• presence of hearing impairment
• lack of capacity to consent
• non-interventional pain procedures, e.g. lignocaine infusion, ketamine infusion
• pregnant women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Li G, Yu L, Yang Y, Deng J, Shao L, Zeng C. Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. J Integr Complement Med. 2024 Jan;30(1):37-46. doi: 10.1089/jicm.2022.0803. Epub 2023 Aug 30. PMID 37646752
• Goel SK, Kim V, Kearns J, Sabo D, Zoeller L, Conboy C, Kelm N, Jackovich AE, Chelly JE. Music-Based Therapy for the Treatment of Perioperative Anxiety and Pain-A Randomized, Prospective Clinical Trial. J Clin Med. 2024 Oct 15;13(20):6139. doi: 10.3390/jcm13206139. PMID 39458090
• Kakde A, Lim MJ, Shen H, Tan HS, Tan CW, Sultana R, Sng BL. Effect of music listening on perioperative anxiety, acute pain and pain catastrophizing in women undergoing elective cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2023 Apr 3;23(1):109. doi: 10.1186/s12871-023-02060-w. PMID 37013499

Идентификаторы

NCT: NCT07252648 · 2025-1781

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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