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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized Music Listening | Experimental | 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. |
|
| Standard Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Music Listening Therapy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately post-surgery in the recovery room. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From hospitalization to Day 28 post-surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MANON LEPRINCE, Clinical Research Associate | Contact | 0692341365 | manon.leprince@clinifutur.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint Vincent | Not yet recruiting | Saint-Denis | 97404 | Reunion |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D012003 | Rectal Fistula |
| D005401 | Fissure in Ano |
| D005402 | Fistula |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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.
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| 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) | 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). | 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. | During the hospital stay. |
| Total Analgesic Consumption During Hospital Stay | The total amount of analgesic medication consumed during the entire hospital stay. | 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. | 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). | From hospitalization to Day 28 post-surgery. |
| Patient Satisfaction | Measurement of patient satisfaction using a Likert scale upon discharge from the recovery room (SSPI). | 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). | During the hospital stay. |
| Clinique Saint Vincent | Recruiting | Saint-Denis | 97404 | Reunion |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001004 | Anus Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |