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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint-Vincent

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative Music Therapy Session

    Other intervention

    Upon admission to the operating room: Patients in the music therapy group will undergo a 20-minute music therapy session while lying on a stretcher in a designated room. This session will be conducted using the Music Care® application (https://www.music.care). The sessions are standardized and divided into several phases, following a U-shaped sequence. The effect of this U-sequence is first achieved by a phase of reduced tempo, instrumental density, frequency, and sound volume , followed by a phase of reactivation . Patients will be allowed to choose the musical style based on their preferences (influenced by their musical tastes and ethnicity). Given the ethnically diverse population of Réunion Island, a wide range of musical preferences is expected.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Intervention Arm: Passive Music TherapyExperimental treatment 1 intervention
Group B: Control Arm: Standard Care (No Music Therapy)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Variation in Anxiety VAS (VAS-A)

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.

Time frame
From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)

Secondary outcomes

1

Anxiety VAS (VAS-A) at Key Surgical Phases

Anxiety levels measured using the Visual Analog Scale (VAS-A, ranging from 0 to 10)

Time frame
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
2

STAI-Y-STATE Anxiety Questionnaire

Anxiety levels will be measured using the STAI-Y-STATE questionnaire (State-Trait Anxiety Inventory Form Y), which uses a 4-point Likert scale ranging from 1 to 4 . Higher scores indicate greater levels of anxiety, while lower scores indicate less anxiety. Anxiety scores will be recorded at two key points: upon hospital admission and at discharge.

Time frame
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)
3

Total Analgesic Consumption During Hospital Stay

The total amount of analgesic medication consumed during the entire hospital stay.

Time frame
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).
4

Blood Pressure at Various Time Points

Blood pressure measurements, including both systolic and diastolic values, taken at several critical time points: upon hospital admission, upon arrival in the operating room, at the start of anesthesia induction, upon exit from PACU, and upon hospital discharge.

Time frame
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).

Other outcomes

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