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

NCT06600919 | Recruiting

• 1 other identifier: CSV2024-2
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

Music therapy; Preoperative anxiety; ENT surgery; Passive music therapy; Randomized controlled trial; Perioperative anxiety; Postoperative pain; Patient care improvement; Clinical research; Music Care® application; Music Care®; Surgical intervention; Anxiety prevention; Music therapy session; Cervical surgery; Endonasal surgery; Otologic surgery; Oropharyngolaryngeal surgery; Musical therapy

Outcome Measures

Primary Outcomes (1)

• Variation in Anxiety VAS (VAS-A)

  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 Outcomes (8)

• Anxiety VAS (VAS-A) at Key Surgical Phases

  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

  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

  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

  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

  During the entire surgical process.

Study Arms (2)

Intervention Arm: Passive Music Therapy

EXPERIMENTAL

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

Control Arm: Standard Care (No Music Therapy)

NO INTERVENTION

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

Interventions

Preoperative Music Therapy Session 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.

Intervention Arm: Passive Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Saint-Vincent: lead

Study Sites (1)

Clinique Saint Vincent

Saint-Denis, 97400, Reunion

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Ear Diseases; Laryngeal Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

MANON LEPRINCE, Clinical Research Associate

CONTACT

0692341365; manon.leprince@clinifutur.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel arms (intervention group receiving passive music therapy and control group not receiving it)

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)