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

Clinique Saint-Vincent

Status: Enrolling

Conditions: Hemorrhoid; Anal Fistulas; MUSICAL THERAPY; Anal Fissure and Fistula

Treatments: Other: Standardized Music Listening Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06798155

24.04190.000403

Details and patient eligibility

About

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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Standardized Music Listening

Experimental group

Description:

Participants assigned to this arm will benefit from standardized music listening sessions via the Music Care® application. Pre-surgery: At the entrance to the operating room, participants will spend 20 minutes lying on a stretcher in a dedicated room, listening to relaxing music sequences through a tablet and headphones provided by the research team. Participants can select their preferred musical style, tempo, and tracks. Post-surgery: Participants will continue listening to music sequences daily for 20 minutes at home using their own devices (smartphone, tablet, or computer) until day 28 post-surgery.

Treatment:

Other: Standardized Music Listening Therapy

Standard Care

No Intervention group

Description:

Participants assigned to this arm will not benefit from standardized music listening sessions. Pre-surgery: Participants will proceed directly from their hospital room to the operating room without a music listening session. Post-surgery: Participants will be managed according to standard care practices, with no additional interventions related to music therapy.