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

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.

Study Overview

• Status: Recruiting
• Conditions: Anal Fistulas; Hemorrhoid; Anal Fissure and Fistula; MUSICAL THERAPY
• Intervention / Treatment: Other: Standardized Music Listening Therapy

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MANON LEPRINCE, Clinical Research Associate; Phone Number: 0692341365; Email: manon.leprince@clinifutur.net

Study Locations

• Réunion
  • Saint Denis, Réunion, 97404
    • Not yet recruiting
    • Clinique Saint Vincent
    • Contact: MANON LEPRINCE; Phone Number: 0692341365; Email: manon.leprince@clinifutur.net
    • Principal Investigator: Sarah BEKKAR, Doctor
    • Sub-Investigator: Guylène Gadsaud Dauvin, Doctor
  • Saint Denis, Réunion, 97404
    • Recruiting
    • Clinique Saint Vincent
    • Contact: MANON LEPRINCE; Phone Number: 0692341365; Email: manon.leprince@clinifutur.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized Music Listening; 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; 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
No Intervention: Standard Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Analgesic Consumption During Hospital Stay	The total amount of analgesic medication consumed during the entire 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).
Successive Pain and Anxiety Scores (EVA Pain and EVA Anxiety)	Successive measurements of pain and anxiety using the EVA scales, scored from 0 to 10, at the following time points: Admission to hospitalization. 30 minutes after premedication. In the recovery room (SSPI). At hospital discharge. Day 10 (±3 days). Day 28 (follow-up visit).	From hospitalization to Day 28 post-surgery.
State Anxiety Score (STAI-Y-ETAT)	Evaluation of state anxiety using the STAI-Y-ETAT scale at the following time points: Admission to hospitalization. 30 minutes after premedication. At hospital discharge. Day 28 (follow-up visit)	From hospitalization to Day 28 post-surgery.
Kess Score	Measurement of bowel function using the Kess score at the following time points: Admission to hospitalization. 30 minutes after premedication. Day 10 (±3 days). Day 28 (follow-up visit).	From hospitalization to Day 28 post-surgery
Total Time in SSPI and Hospitalization Duration	Measurement of the total time spent in the recovery room (SSPI) and overall hospitalization duration.	During the hospital stay.
Time to Healing	Measurement of wound healing time by assessing wound surface area using the Imito Measure application, in the genu-pectoral position.	From surgery to Day 28 post-surgery.
Quality of Life Scores (HEMO-FISS-QoL and EQ5D-5L)	Assessment of quality of life using the HEMO-FISS-QoL and EQ5D-5L scales at the following time points:Admission to hospitalization. Day 28 (follow-up visit).	From hospitalization to Day 28 post-surgery.
Patient Satisfaction	Measurement of patient satisfaction using a Likert scale upon discharge from the recovery room (SSPI).	Immediately post-surgery, upon discharge from SSPI.
Medico-Economic Impact	Assessment of the economic impact of the intervention by recording: Operative times. Recovery room durations. Total hospitalization duration (in minutes).	During the hospital stay.

Collaborators and Investigators

• Sponsor: Clinique Saint-Vincent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Preoperative Care; Pain Management; Music Intervention; Standardized Music Therapy; Proctologic Surgery; Analgesic Use; Monocentric Study
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Anus Diseases; Digestive System Fistula; Intestinal Fistula; Hemorrhoids; Fistula; Rectal Fistula; Fissure in Ano
• Other Study ID Numbers: 24.04190.000403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No