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

Clinique Saint-Vincent

Status: Enrolling

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

Treatments: Other: Preoperative Music Therapy Session

Study type: Interventional

Funder types: Other

Identifiers

NCT06600919

CSV2024-2

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Intervention Arm: Passive Music Therapy

Experimental group

Description:

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.

Treatment:

Other: Preoperative Music Therapy Session

Control Arm: Standard Care (No Music Therapy)

No Intervention group

Description:

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