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

NCT ID: NCT06600919

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2027-02-28

Brief Summary

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).

Conditions

Cervical Surgery; Endonasal Surgery; Otologic Disease; Oropharyngeal Disease; Laryngeal Disease; ENT Surgery; Musical Therapy; Laryngeal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Preoperative Music Therapy Session

Intervention Type: OTHER

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.

Control Arm: Standard Care (No Music Therapy)

Participants in the Control Arm will receive standard care without the intervention of passive music therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique Saint-Vincent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Saint Vincent

Saint-Denis, , Reunion

Site Status: RECRUITING

Countries

Reunion

Central Contacts

MANON LEPRINCE, Clinical Research Associate

Role: CONTACT

manon.leprince@clinifutur.net

0692341365

Facility Contacts

MANON LEPRINCE, Clinical Research Associate

Role: primary

manon.leprince@clinifutur.net

0692341365

Related Links

https://www.music.care/

Related Info

Other Identifiers

CSV2024-2

Identifier Type: -

Identifier Source: org_study_id