Comparing Professionally-prescribed Music by Music Therapist Versus Standard Practice Using Intravenous Sedative-hypnotic Agents on the Anxiolytic and Sedative Effect During Regional Anaesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
研究概览
简要总结
Perioperative anxiety is common among patients undergoing surgery under regional anaesthesia. Intravenous sedative-hypnotic agents such as propofol are commonly administered to reduce anxiety and improve patient comfort; however, pharmacological sedation may reduce patient alertness and cause cardiorespiratory adverse effects. Music may provide a non-pharmacological alternative for reducing perioperative anxiety.
This prospective controlled study compared professionally prescribed individualized music with intravenous propofol sedation in adult patients undergoing surgery under regional anaesthesia. Participants in the music group received an individualized playlist curated by a professional music therapist following assessment of their music preferences and listening history. Participants in the sedative-hypnotic group received intravenous propofol sedation titrated according to clinical assessment.
Perioperative anxiety was assessed before and after surgery using the State-Trait Anxiety Inventory-State (STAI-S) and a visual analogue scale (VAS). Intraoperative sedation and alertness were assessed using the Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (mOAA/S), together with haemodynamic monitoring and patient satisfaction.
详细描述
This was a prospective, single-centre, parallel-group controlled study conducted at University Malaya Medical Centre, Kuala Lumpur, Malaysia. Adult patients scheduled for surgery under regional anaesthesia were allocated to either a music-therapy group or a sedative-hypnotic group according to their scheduled operating day.
Participants assigned to the music intervention underwent a preoperative assessment by a professional music therapist. The assessment included the participant's music-listening history and preferences, following which an individualized playlist was curated for intraoperative listening through headphones.
Participants assigned to the sedative-hypnotic group received intravenous propofol using target-controlled infusion, titrated according to clinical assessment and sedation monitoring.
Anxiety was evaluated preoperatively and postoperatively using STAI-S and an anxiety VAS. Intraoperative BIS, mOAA/S, haemodynamic variables and relevant rescue interventions were recorded. Postoperative patient satisfaction was also assessed.
The study received approval from the Medical Research Ethics Committee, University Malaya Medical Centre (MREC ID 2023418-12366), before participant recruitment, and written informed consent was obtained from all participants. The study was completed before registration on ClinicalTrials.gov.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and investigators administering the interventions were not masked because of the nature of the interventions. Postoperative outcome assessment was performed by a research assistant who was blinded to group allocation. The statistician conducting the original analysis was also blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •No sedative or anxiolytic medication received before surgery that could affect measurement of vital signs or Bispectral Index (BIS).
- •Able to understand and communicate in Malay or English, understand the purpose and objectives of the study, and provide written informed consent.
- •Surgery planned under regional anaesthesia (spinal, epidural, or peripheral nerve block).
- •Surgery performed in the supine position.
排除标准
- •Received general anaesthesia.
- •Refused to participate.
- •Hearing impairment.
- •Diagnosed neurocognitive or psychiatric disorder.
- •Aggressive or uncooperative behaviour.
- •Surgery duration exceeding 3 hours.
研究组 & 干预措施
Professionally Prescribed Individualized Music
Participants received professionally prescribed individualized music during surgery under regional anaesthesia. Before surgery, a professional music therapist assessed each participant's music-listening history and preferences and curated an individualized playlist. Music was delivered intraoperatively through headphones. Rescue intravenous sedation could be administered when clinically required.
干预措施: Professionally Prescribed Individualized Music (Behavioral)
Intravenous Propofol Sedation
Participants received intravenous propofol sedation during surgery under regional anaesthesia using target-controlled infusion. Propofol was titrated according to clinical assessment and sedation monitoring.
干预措施: propofol (Drug)
结局指标
主要结局
Change in State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
时间窗: Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S) before and after surgery. The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. The outcome was the change in STAI-S score from the preoperative to the postoperative assessment.
次要结局
- Change in Anxiety Visual Analogue Scale (VAS) Score(Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery)
- Intraoperative Bispectral Index (BIS)(Every 10 minutes from the start of surgery until completion of surgery.)
- Intraoperative Level of Sedation Measured by Modified Observer's Assessment of Alertness/Sedation (mOAA/S)(Every 10 minutes from the start of surgery until completion of surgery.)
- Intraoperative Systolic Blood Pressure(Every 10 minutes from the start of surgery until completion of surgery.)
- Intraoperative Diastolic Blood Pressure(Every 10 minutes from the start of surgery until completion of surgery)
- Intraoperative Heart Rate(Every 10 minutes from the start of surgery until completion of surgery)
- Postoperative Patient Satisfaction(Postoperative period: During assessment in the post-anaesthesia recovery room, on the same day of surgery)