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

Recruiting now · Not applicable

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

In brief

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).

Key facts

Study ID: NCT06600919
Run by: Clinique Saint-Vincent
People needed: 500
Starts: 2024-11-15
Expected to finish: 2027-02-01
Last updated by the study team: 2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Clinique Saint Vincent — Saint-Denis, Reunion (enrolling)

Full record on ClinicalTrials.gov

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