Actively Recruiting
Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
Led by Clinique Saint-Vincent · Updated on 2026-03-18
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Music therapy uses the effects of music on the body and mind to help treat illness or trauma. This research focuses on passive music therapy, where patients listen to calming music, to see if it can reduce anxiety and pain around the time of ENT (ear, nose, throat) surgery. Previous smaller studies suggested benefits but were limited by their size, so this study includes a larger patient group to better understand the effects. The study compares two groups: one that receives a 20-minute session of passive music therapy using an app before surgery, and a control group that receives standard care without music therapy. The music therapy involves listening to selected calming music through headphones while resting before entering the operating room. This randomized study will be conducted at a single center with about 500 participants. Participants will be involved for about two days, covering admission, surgery, and discharge. Researchers will measure anxiety levels using visual scales and questionnaires, monitor pain levels, blood pressure, medication use, surgery timing, and satisfaction of patients and staff. The study will also look at the economic impact of the therapy during the hospital stay, with all assessments done within 6 to 24 hours depending on the surgery type.
CONDITIONS
Brief Title
Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Signed informed consent
- Scheduled for ENT surgery (cervical, endonasal, otologic, oropharyngeal-laryngeal) at the study site
- Affiliated with or beneficiary of a social security system
You will not qualify if you...
- Refusal to provide consent
- Severe bilateral hearing loss greater than 70 dB HL
- Unable to read, write, or understand French
- Vulnerable patient as defined by French Public Health Code
- Under guardianship, curatorship, or judicial protection
- Unable to personally provide consent
- Pregnant or breastfeeding women
- Prior participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Less than 1 day (perioperative period)
Participants in the Passive Music Therapy arm will undergo a 20-minute music therapy session using an app before entering the operating room. Participants in the Control arm will receive standard care without music therapy.
1 preoperative visit (in-person)
Duration - Up to 24 hours after surgery
Participants are monitored during the outpatient hospital stay for up to 24 hours after surgery to assess anxiety, pain, blood pressure, analgesic use, and satisfaction.
1 to 2 visits depending on timing of discharge
Trial Site Locations
Total: 1 location
1
Clinique Saint Vincent
Saint-Denis, Reunion, 97400
Actively Recruiting
Research Team
M
MANON LEPRINCE, Clinical Research Associate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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