HemorrhoidMUSICOPROCTONCT06798155
Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
A study testing Standardized Music Listening Therapy in people with Hemorrhoid and Anal Fistulas, run by Clinique Saint-Vincent at 2 sites in Reunion.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoid, Anal Fistulas, MUSICAL THERAPY
- What is being tested?
- Standardized Music Listening Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 2 sitesReunion
- Study dates
- 3 Feb 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reunion2 sites, 2 recruiting
- Not yet recruiting
Clinique Saint Vincent
Saint-Denis, 97404
MANON LEPRINCE, 0692341365, manon.leprince@clinifutur.net
Sarah BEKKAR, Doctor
- Recruiting
Clinique Saint Vincent
Saint-Denis, 97404
MANON LEPRINCE, 0692341365, manon.leprince@clinifutur.net
About this study
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.
Read more
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.
- Conditions
- Hemorrhoid, Anal Fistulas, MUSICAL THERAPY, Anal Fissure and Fistula
- Being tested
- Standardized Music Listening Therapy
- Keywords
- Standardized Music Therapy, Proctologic Surgery, Pain Management, Analgesic Use, Randomized Controlled Trial, Music Intervention, Preoperative Care, Monocentric Study
- Medical subject headings
- Hemorrhoids, Rectal Fistula, Fissure in Ano, Fistula, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Music Listening TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standardized Music Listening Therapy |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately post-surgery in the recovery room.
Secondary outcomes (9)
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).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: During the hospital stay.
Total Analgesic Consumption During Hospital Stay
The total amount of analgesic medication consumed during the entire hospital stay.
Measured: 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.
Measured: 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).
Measured: From hospitalization to Day 28 post-surgery.
Patient Satisfaction
Measurement of patient satisfaction using a Likert scale upon discharge from the recovery room (SSPI).
Measured: 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).
Measured: During the hospital stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start3 Feb 2025
- Primary completion1 Apr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint-Vincent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798155
- Sponsor's protocol ID
- 24.04190.000403
- Acronym
- MUSICOPROCTO
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
- ClinicalTrials.gov ID
- NCT06798155
- Acronym / sponsor ID
- MUSICOPROCTO / 24.04190.000403
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Clinique Saint-VincentUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standardized Music Listening | Experimental | Other: Standardized Music Listening TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Music Listening TherapyType 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 | Other | Standardized Music Listening |
Primary outcome
Pain Intensity (EVA Pain) in the recovery room (SSPI).
Time frame: Immediately post-surgery in the recovery room.
First postoperative pain measurement using the EVA (Visual Analog Scale), scored from 0 to 10, in the recovery room (SSPI).
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Music Listening Therapy in people with Hemorrhoid and Anal Fistulas, run by Clinique Saint-Vincent at 2 sites in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MANON LEPRINCE, Clinical Research Associate (0692341365, manon.leprince@clinifutur.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (EVA Pain) in the recovery room (SSPI). (time frame: Immediately post-surgery in the recovery room.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.