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.
