Effect of Peri-Operative Music Therapy on Anxiety, Pain Catastrophising, and Pain in Chronic Pain Patients Undergoing Interventional Pain Procedures - A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Singapore General Hospital
- Enrollment
- 110
- Primary Endpoint
- Postoperative Anxiety (Visual Analogue Scale)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged ≥21years
- •chronic pain ≥3 months
- •scheduled for interventional pain procedures
Exclusion Criteria
- •presence of hearing impairment
- •lack of capacity to consent
- •non-interventional pain procedures, e.g. lignocaine infusion, ketamine infusion
- •pregnant women
Arms & Interventions
Music Therapy
Participants will listen to self-selected music before, during, and after the interventional pain procedure via headphones. Bluetooth speakers will be used during the procedure to facilitate communication with the healthcare team.
Intervention: Music Therapy (Behavioral)
Standard Care
Participants will receive routine peri-procedural care without music therapy.
Outcomes
Primary Outcomes
Postoperative Anxiety (Visual Analogue Scale)
Time Frame: Scores will be recorded before the procedure (baseline) and post-procedure within 30 minutes.
Postoperative anxiety will be assessed using the Visual Analogue Scale for Anxiety, a 10-cm scale ranging from 0 (not anxious at all) to 10 (extremely anxious).
Secondary Outcomes
- Pain Catastrophising Score(This will be measured before the procedure (baseline) and post-procedure within 30 minutes.)
- Postoperative Anxiety (State-Trait Anxiety Inventory Short Form)(This will be measured at baseline (pre-procedure) and post-procedure (within 30 minutes of completion).)
- Postoperative Pain Score(Participants will rate their pain after the procedure in the recovery area (within 30 minutes).)
- Patient Satisfaction(Within 30 minutes of the procedure.)