Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Variation in Anxiety VAS (VAS-A)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Preoperative Music Therapy Session (Other)
Control Arm: Standard Care (No Music Therapy)
Participants in the Control Arm will receive standard care without the intervention of passive music therapy.
Outcomes
Primary Outcomes
Variation in Anxiety VAS (VAS-A)
Time Frame: From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)
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.
Secondary Outcomes
- 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.)
- Patient and Staff Satisfaction via Likert Scale(Measured at the time of the patient's exit from PACU, within an estimated time frame of 0 to 4 hours after surgery)
- Medical-Economic Impact(Measured from the start of surgery until hospital discharge, within an estimated time frame of 1 to 6 hours, depending on the specific procedure and recovery time.)
- Variation in Pain VAS (VAS-P)(Measured at hospital admission, arrival in the operating room, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (depending on the outpatient procedure).)