RecruitingNot ApplicableNCT06798155

Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery

Sponsor

Clinique Saint-Vincent

Enrollment

550 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

Hemorrhoid Anal Fistulas

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERStandardized Music Listening Therapy

Type of Intervention: Pre- and postoperative listening to standardized music sequences designed specifically for relaxation and pain management. Delivery Method: Sessions are conducted via the Music Care® application, using a tablet and headphones provided during hospitalization. Participants select their preferred music style, tempo, and tracks to tailor the experience to their preferences. Duration and Schedule: Pre-surgery: One 20-minute session in a dedicated room before entering the operating theater. Post-surgery: Daily 20-minute sessions at home for 28 days post-surgery using participants' own devices (smartphone, tablet, or computer). Purpose: To evaluate the effect of music on reducing postoperative pain, minimizing analgesic use, and improving the quality of life. Distinctiveness: This intervention uniquely integrates patient-controlled music preferences with a structured listening regimen before and after surgery, offering a personalized approach to enhancing recovery outcom