Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standardized Music Listening Therapy.
- Who it may be relevant to
- Registry conditions: Hemorrhoid, Anal Fistulas, MUSICAL THERAPY, Anal Fissure and Fistula. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Reunion
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 oper
Primary outcome measures
- Pain Intensity (EVA Pain) in the recovery room (SSPI). [Time frame: Immediately post-surgery in the recovery room.]
Secondary outcome measures (9)
- Successive Pain and Anxiety Scores (EVA Pain and EVA Anxiety) [Time frame: From hospitalization to Day 28 post-surgery.]
- State Anxiety Score (STAI-Y-ETAT) [Time frame: From hospitalization to Day 28 post-surgery.]
- Kess Score [Time frame: From hospitalization to Day 28 post-surgery]
- Total Time in SSPI and Hospitalization Duration [Time frame: During the hospital stay.]
- Total Analgesic Consumption During 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 [Time frame: From surgery to Day 28 post-surgery.]
- Quality of Life Scores (HEMO-FISS-QoL and EQ5D-5L) [Time frame: From hospitalization to Day 28 post-surgery.]
- Patient Satisfaction [Time frame: Immediately post-surgery, upon discharge from SSPI.]
- Medico-Economic Impact [Time frame: During the hospital stay.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Reunion · 2 centers
- Clinique Saint Vincent — Saint-Denis
- Clinique Saint Vincent — Saint-Denis
Identifiers
NCT: NCT06798155 · 24.04190.000403