Clinical trial NCT06798155: Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
Official title: Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Clinique Saint-Vincent
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity (EVA Pain) in the recovery room (SSPI).
timeFrame: Immediately post-surgery in the recovery room.
Secondary outcomes:
measure: Successive Pain and Anxiety Scores (EVA Pain and EVA Anxiety)
timeFrame: From hospitalization to Day 28 post-surgery.
measure: State Anxiety Score (STAI-Y-ETAT)
timeFrame: From hospitalization to Day 28 post-surgery.
measure: Kess Score
timeFrame: From hospitalization to Day 28 post-surgery
measure: Total Time in SSPI and Hospitalization Duration
timeFrame: During the hospital stay.
measure: Total Analgesic Consumption During Hospital Stay
timeFrame: 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).
measure: Time to Healing
timeFrame: From surgery to Day 28 post-surgery.
measure: Quality of Life Scores (HEMO-FISS-QoL and EQ5D-5L)
timeFrame: From hospitalization to Day 28 post-surgery.
measure: Patient Satisfaction
timeFrame: Immediately post-surgery, upon discharge from SSPI.
measure: Medico-Economic Impact
timeFrame: During the hospital stay.
Other outcomes:
Locations:
city: Saint Denis
country: Réunion
facility: Clinique Saint Vincent
Study officials:
References: