Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctolog… (NCT06798155) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
Reunion550 participantsStarted 2025-02-03
Plain-language summary
The study, "Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery," aims to evaluate the impact of preoperative listening to standardized music sequences on postoperative pain in patients undergoing proctologic surgery (for hemorrhoids, fistulas, or anal fissures).
This research will assess the influence of preoperative music on postoperative pain management, the use of analgesics after surgery and during the following month, and its effect on the quality of life post-surgery.
MUSICO-PROCTO is an interventional, randomized study involving two groups (patients will be randomly assigned to either the music intervention or control group). The study is monocentric, conducted at Clinique Saint Vincent in France, and includes 550 participants.
Participants will be followed for 28 days, while the overall study duration will span 28 months.
To participate, individuals must:
Be aged 18 or older. Be affiliated with a social security system. Provide signed informed consent. Undergo proctologic surgery for hemorrhoids, fistulas, or anal fissures. This study seeks to explore the potential of music as a complementary method to improve postoperative outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity (EVA Pain) in the recovery room (SSPI).
Timeframe: Immediately post-surgery in the recovery room.