Clinical trial NCT06600919: Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
Official title: Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Clinique Saint-Vincent
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel arms (intervention group receiving passive music therapy and control group not receiving it)
Primary purpose: PREVENTION

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).


Eligibility criteria: 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 (\&gt; 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

Primary outcomes:
measure: Variation in Anxiety VAS (VAS-A)
timeFrame: From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)
Secondary outcomes:
measure: Anxiety VAS (VAS-A) at Key Surgical Phases
timeFrame: 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
measure: STAI-Y-STATE Anxiety Questionnaire
timeFrame: 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)
measure: Total Analgesic Consumption During Hospital Stay
timeFrame: 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).
measure: Blood Pressure at Various Time Points
timeFrame: 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).
measure: Surgical and Anesthesia Timeline
timeFrame: During the entire surgical process.
measure: Patient and Staff Satisfaction via Likert Scale
timeFrame: Measured at the time of the patient's exit from PACU, within an estimated time frame of 0 to 4 hours after surgery
measure: Medical-Economic Impact
timeFrame: 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.
measure: Variation in Pain VAS (VAS-P)
timeFrame: 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).
Other outcomes:
Locations:
city: Saint Denis
country: Réunion
facility: Clinique Saint Vincent
Study officials:
References: