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

Обзор

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).

Вмешательства

• Другое Preoperative Music Therapy Session
  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

Первичные конечные точки

• Variation in Anxiety VAS (VAS-A) [Срок оценки: From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)]

Вторичные конечные точки (8)

• Anxiety VAS (VAS-A) at Key Surgical Phases [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: During the entire surgical process.]
• Patient and Staff Satisfaction via Likert Scale [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Reunion · 1 центр

• Clinique Saint Vincent — Saint-Denis

Идентификаторы

NCT: NCT06600919 · CSV2024-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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