Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery (MUSICORL)

March 17, 2026 updated by: Clinique Saint-Vincent

Music therapy is a controlled method of listening to music, utilizing its physiological, psychological, and emotional effects on humans during the treatment of illness or trauma. It is considered active when it involves playing musical instruments and passive when it involves listening to music (via headphones, television, stereo systems, etc.).

The benefits of this technique in treating chronic pain (i.e., pain lasting several weeks, such as chronic back pain, osteoarthritis, etc.) have been demonstrated. Numerous studies have also examined the effect of music therapy on acute postoperative pain and anxiety related to surgical interventions. These studies suggest, though without conclusive evidence, that a single session of music therapy just before entering the operating room may reduce postoperative pain and anxiety.

However, all of these studies were limited by relatively small sample sizes (a few hundred patients), leaving some scientific uncertainty regarding the effectiveness of music therapy in the context of surgical interventions.

This research will therefore evaluate the impact of preoperative passive music therapy on perioperative anxiety and postoperative pain, with a larger number of patients included in the study than has been previously reported in the scientific literature.

The primary objective of this study is to assess the impact of preoperative passive music therapy on perioperative anxiety in patients undergoing ENT surgery. MUSICORL is an interventional, randomized study (the assignment to receive or not receive music therapy will be determined by randomization) with two parallel arms. This is a single-center study, conducted at a single French site: Clinique Saint Vincent. A total of 500 subjects will participate in this study. Your participation will last for 2 days; the overall study duration will be 27 months.

To participate in this research, you must be affiliated with a social security system, be over 18 years old, have signed informed consent, and be scheduled for ENT surgery (cervical, endonasal, otologic, oropharyngeal-laryngeal).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Reunion
      • Saint-Denis, Reunion, 97400
        • Recruiting
        • Clinique Saint Vincent
        • Contact:
        • Principal Investigator:
          • François RUBIN, Doctor
        • Sub-Investigator:
          • Jean-François VELLIN, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female, aged 18 years or older
  • Patient has signed informed consent
  • Patient scheduled to undergo ENT surgery (cervical, endonasal, otologic, oropharyngeal-laryngeal) at the participating facility
  • Patient is affiliated with or a beneficiary of a social security system

Exclusion Criteria:

  • Refusal to provide consent
  • Patient with severe bilateral hearing loss (> 70 dB HL)
  • Patient unable to read, write, or understand French
  • Vulnerable patient as defined by Article L1121-6 of the French Public Health Code (CSP)
  • Adult patient under guardianship, curatorship, or judicial protection
  • Patient unable to personally provide consent as per Article L1121-8 of the CSP or an adult under legal protection
  • Pregnant or breastfeeding women as per Article L1121-5 of the CSP
  • Patient who has already participated in the current study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm: Passive Music Therapy
Participants in the Passive Music Therapy arm will receive preoperative music therapy designed to reduce perioperative anxiety. The intervention will involve listening to calming music via headphones for a 20 minutes before entering the operating room.
Other: Preoperative Music Therapy Session

Upon admission to the operating room:

Patients in the music therapy group will undergo a 20-minute music therapy session while lying on a stretcher in a designated room. This session will be conducted using the Music Care® application (https://www.music.care).

The sessions are standardized and divided into several phases, following a U-shaped sequence. The effect of this U-sequence is first achieved by a phase of reduced tempo, instrumental density, frequency, and sound volume , followed by a phase of reactivation .

Patients will be allowed to choose the musical style based on their preferences (influenced by their musical tastes and ethnicity). Given the ethnically diverse population of Réunion Island, a wide range of musical preferences is expected.
No Intervention: Control Arm: Standard Care (No Music Therapy)
Participants in the Control Arm will receive standard care without the intervention of passive music therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in Anxiety VAS (VAS-A)
Time Frame: From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)
Change in the anxiety Visual Analog Scale (VAS-A, ranging from 0 to 10) measured during the hospital stay. The anxiety levels will be recorded at two key time points: admission to the hospital and discharge.
From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety VAS (VAS-A) at Key Surgical Phases
Time Frame: Measured at arrival in the operating room and upon exit from the Post-Anesthesia Care Unit (PACU), within an estimated time frame of 2 to 6 hours
Anxiety levels measured using the Visual Analog Scale (VAS-A, ranging from 0 to 10)
Measured at arrival in the operating room and upon exit from the Post-Anesthesia Care Unit (PACU), within an estimated time frame of 2 to 6 hours
STAI-Y-STATE Anxiety Questionnaire
Time Frame: Measured at hospital admission and hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure)
Anxiety levels will be measured using the STAI-Y-STATE questionnaire (State-Trait Anxiety Inventory Form Y), which uses a 4-point Likert scale ranging from 1 to 4 . Higher scores indicate greater levels of anxiety, while lower scores indicate less anxiety. Anxiety scores will be recorded at two key points: upon hospital admission and at discharge.
Measured at hospital admission and hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure)
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).
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).
Blood Pressure at Various Time Points
Time Frame: Measured at hospital admission, arrival in the operating room, start of induction, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).
Blood pressure measurements, including both systolic and diastolic values, taken at several critical time points: upon hospital admission, upon arrival in the operating room, at the start of anesthesia induction, upon exit from PACU, and upon hospital discharge.
Measured at hospital admission, arrival in the operating room, start of induction, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).
Surgical and Anesthesia Timeline
Time Frame: During the entire surgical process.
Key time points during the surgical process will be recorded, including: time of entry into the operating room, start of anesthesia induction, time of incision, time of wound closure, end of anesthesia, exit from the operating room, entry into PACU, and exit from PACU.
During the entire surgical process.
Patient and Staff Satisfaction via Likert Scale
Time Frame: Measured at the time of the patient's exit from PACU, within an estimated time frame of 0 to 4 hours after surgery
Satisfaction levels of both patients and healthcare staff will be evaluated using a 5-point Likert scale (ranging from 1 to 5). Higher scores indicate greater satisfaction, while lower scores indicate less satisfaction.
Measured at the time of the patient's exit from PACU, within an estimated time frame of 0 to 4 hours after surgery
Medical-Economic Impact
Time Frame: Measured from the start of surgery until hospital discharge, within an estimated time frame of 1 to 6 hours, depending on the specific procedure and recovery time.
The economic impact will be assessed by measuring the duration of surgery, duration of stay in the PACU, and overall length of hospital stay (measured in minutes).
Measured from the start of surgery until hospital discharge, within an estimated time frame of 1 to 6 hours, depending on the specific procedure and recovery time.
Variation in Pain VAS (VAS-P)
Time Frame: Measured at hospital admission, arrival in the operating room, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (depending on the outpatient procedure).
Pain levels measured using the Visual Analog Scale (VAS-P, ranging from 0 to 10) at several time points during the hospital stay: upon admission, upon arrival in the operating room, upon exit from the post-anesthesia care unit (PACU), and at hospital discharge.
Measured at hospital admission, arrival in the operating room, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (depending on the outpatient procedure).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Saint-Vincent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSV2024-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Laryngeal Disease

Clinical Trials on Preoperative Music Therapy Session

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe