Listening to standardized music before proctologic surgery to reduce postoperative pain
Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
This study tests whether listening to standardized music before proctologic surgery helps reduce postoperative pain, cut painkiller use, and improve recovery for adults having hemorrhoid, fistula, or fissure procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Saint-Vincent Academic / other |
| Locations | 2 sites (Saint-Denis and 1 other locations) |
| Trial ID | NCT06798155 on ClinicalTrials.gov |
What this trial studies
MUSICO-PROCTO is a randomized, monocentric trial at Clinique Saint-Vincent in Saint-Denis, France that assigns 550 adult patients undergoing proctologic surgery to either a standardized music-listening intervention or a control group. Participants will use the Music Care® application preoperatively and outcomes include postoperative pain scores, analgesic consumption during the first month, and quality of life measures. Randomization balances the two groups and follow-up occurs over 28 days for each participant, with the overall study spanning 28 months. The protocol requires French language ability, social security affiliation, and access to a smartphone, tablet, or computer to deliver the intervention.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for proctologic surgery (hemorrhoids, anal fistula, or anal fissure) at Clinique Saint-Vincent who have social security coverage and access to a smartphone, tablet, or computer are ideal candidates.
Not a fit: Patients who cannot use the Music Care® app, do not read or understand French, are pregnant or legally protected, or who have conditions that limit response to music-based interventions may not receive benefit.
Why it matters
Potential benefit: If successful, the intervention could lower postoperative pain and reduce analgesic use after proctologic surgery, improving patient comfort and recovery.
How similar studies have performed: Randomized trials in other surgical settings have reported modest reductions in postoperative pain and analgesic use with standardized music interventions, but application to proctologic surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, aged over 18 years. * Patient who has signed an informed consent form. * Patient scheduled to undergo proctological surgery (for hemorrhoids, fistula, or anal fissure) at the participating institution. * Must be affiliated with a social security system or be a beneficiary of such a system. * Patient must have access to the necessary technical means (smartphone, computer, tablet) to use the Music Care® application. Exclusion Criteria: * Refusal to consent. * Patient unable to read, write, or understand French. * Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP). * Adult patient under guardianship or curatorship or under legal protection (safeguard of justice). * Patient unable to personally give informed consent according to Article L.1121-8 of the CSP or an adult protected by law. * Pregnant or breastfeeding women according to Article L1121-5 of the CSP. * Patient who has already participated in a study within the last 12 months.
Where this trial is running
Saint-Denis and 1 other locations
- Clinique Saint Vincent — Saint-Denis, Reunion (Not_yet_recruiting)
- Clinique Saint Vincent — Saint-Denis, Reunion (Recruiting)
Study contacts
- Study coordinator: MANON LEPRINCE, Clinical Research Associate
- Email: manon.leprince@clinifutur.net
- Phone: 0692341365
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.