Listening to standardized music before proctologic surgery to reduce postoperative pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique Saint Vincent
  Saint-Denis, Reunion Recruiting
• Clinique Saint Vincent
  Saint-Denis, Reunion Not yet recruiting

Study contacts

• Study coordinator: MANON LEPRINCE, Clinical Research Associate
• Email: manon.leprince@clinifutur.net
• Phone: 0692341365

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.