Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Variation in Anxiety VAS (VAS-A)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
结局指标
主要结局
Variation in Anxiety VAS (VAS-A)
时间窗: 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.
次要结局
- 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).)