Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06798155

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

Led by Clinique Saint-Vincent · Updated on 2025-06-26

550

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how listening to standardized music sequences before and after proctologic surgery affects postoperative pain. This study focuses on patients undergoing surgery for hemorrhoids, fistulas, or anal fissures. The trial aims to understand whether preoperative and postoperative music can help manage pain, reduce the need for pain medications, and improve quality of life after surgery. Participants are randomly assigned to one of two groups. One group listens to relaxing, standardized music sessions via the Music Careae app, with a 20-minute session before surgery in the hospital and daily 20-minute sessions at home for 28 days after surgery. The control group receives standard care without music therapy. All music sessions allow participants to choose their preferred style, tempo, and tracks. During the study, participants will be closely monitored for pain and anxiety levels from hospitalization through 28 days post-surgery. Researchers will assess pain intensity immediately after surgery in the recovery room and track analgesic use, healing time, quality of life, patient satisfaction, and hospital stay duration. The study lasts 28 months overall, with each participant followed for 28 days.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged over 18 years
  • Signed informed consent form
  • Scheduled to undergo proctologic surgery for hemorrhoids, fistulas, or anal fissures
  • Affiliated with a social security system or beneficiary of such a system
  • Access to a smartphone, computer, or tablet to use the Music Care�ae application
Not Eligible

You will not qualify if you...

  • Refusal to consent
  • Unable to read, write, or understand French
  • Considered a vulnerable patient according to French Public Health Code
  • Under guardianship, curatorship, or legal protection
  • Unable to personally give informed consent
  • Pregnant or breastfeeding women
  • Participated in another study within the last 12 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From pre-surgery through 28 days post-surgery

Participants assigned to the music therapy arm listen to standardized music sequences for relaxation and pain management. This includes one 20-minute session before surgery in a dedicated room and daily 20-minute sessions at home for 28 days post-surgery. Participants in the standard care arm receive usual care without music therapy.

1 pre-surgery visit and daily sessions at home for 28 days post-surgery

Follow-up

Duration - Up to 28 days post-surgery

Participants are monitored for pain, anxiety, healing, analgesic use, quality of life, and satisfaction from hospitalization through 28 days after surgery.

Assessments during hospitalization and follow-up at home up to Day 28

Trial Site Locations

Total: 2 locations

1

Clinique Saint Vincent

Saint-Denis, Reunion, 97404

Not Yet Recruiting

2

Clinique Saint Vincent

Saint-Denis, Reunion, 97404

Actively Recruiting

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Research Team

M

MANON LEPRINCE, Clinical Research Associate

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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