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

NCT06798155 | Recruiting

• 1 other identifier: 24.04190.000403
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Standardized Music Therapy; Proctologic Surgery; Pain Management; Analgesic Use; Randomized Controlled Trial; Music Intervention; Preoperative Care; Monocentric Study

Outcome Measures

Primary Outcomes (1)

• Pain Intensity (EVA Pain) in the recovery room (SSPI).

  First postoperative pain measurement using the EVA (Visual Analog Scale), scored from 0 to 10, in the recovery room (SSPI).

  Immediately post-surgery in the recovery room.

Secondary Outcomes (9)

• Successive Pain and Anxiety Scores (EVA Pain and EVA Anxiety)

  From hospitalization to Day 28 post-surgery.

• State Anxiety Score (STAI-Y-ETAT)

  From hospitalization to Day 28 post-surgery.

• Kess Score

  From hospitalization to Day 28 post-surgery

• Total Time in SSPI and Hospitalization Duration

  During the hospital stay.

• Total Analgesic Consumption During Hospital Stay

  Measured from hospital admission to hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).

Study Arms (2)

Standardized Music Listening

EXPERIMENTAL

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.

Other: Standardized Music Listening Therapy

Standard Care

NO INTERVENTION

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.

Interventions

Standardized Music Listening Therapy OTHER

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

Standardized Music Listening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Saint-Vincent: lead

Study Sites (2)

Clinique Saint Vincent

Saint-Denis, 97404, Reunion

NOT YET RECRUITING

Clinique Saint Vincent

Saint-Denis, 97404, Reunion

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Hemorrhoids; Rectal Fistula; Fissure in Ano; Fistula; Agnosia

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Intestinal Fistula; Digestive System Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Anus Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Central Study Contacts

MANON LEPRINCE, Clinical Research Associate

CONTACT

0692341365; manon.leprince@clinifutur.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design of this study does not fall within the framework of a specific phase but rather corresponds to a Category 2 study under the Jardé law. In other words, it qualifies as a RIPH2 study.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 29, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RE (2)