An interventional study of Standardized Music Listening Therapy in Hemorrhoid, Anal Fistulas and MUSICAL THERAPY, sponsored by Clinique Saint-Vincent. Recruiting at 2 sites in Reunion. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Clinique Saint-Vincent · Not applicable, Interventional, and Supportive care
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 550 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Clinique Saint-Vincent is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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).
Time frame: Immediately post-surgery in the recovery room.
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).
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: During the hospital stay.
Total Analgesic Consumption During Hospital Stay
The total amount of analgesic medication consumed during the entire hospital stay.
Time frame: 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).
Time to Healing
Measurement of wound healing time by assessing wound surface area using the Imito Measure application, in the genu-pectoral position.
Time frame: 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).
Time frame: From hospitalization to Day 28 post-surgery.
Patient Satisfaction
Measurement of patient satisfaction using a Likert scale upon discharge from the recovery room (SSPI).
Time frame: 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).
Time frame: During the hospital stay.
Plan to share: No
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