Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint-Vincent
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Standardized Music Listening Therapy
Other interventionType 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
Treatment groups
550 Participants
are divided into 2 treatment groupsGroup A: Standardized Music ListeningExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
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).
Time frame
Immediately post-surgery in the recovery room.Secondary outcomes
1
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.2
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.3
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-surgery4
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.Sponsors and contacts
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Source ClinicalTrials.gov