Individualized Music Versus Propofol for Perioperative Anxiety During Regional Anaesthesia
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
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Federal Territory of Kuala L
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Kuala Lumpur、Federal Territory of Kuala L、马来西亚、59100
- University Malaya Medical Centre
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Received general anaesthesia.
- Refused to participate.
- Hearing impairment.
- Diagnosed neurocognitive or psychiatric disorder.
- Aggressive or uncooperative behaviour.
- Surgery duration exceeding 3 hours.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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Participants underwent a preoperative music assessment by a professional music therapist that included music-listening history and individual preferences.
Based on this assessment, the music therapist curated an individualized playlist for each participant.
The prescribed music was delivered intraoperatively through headphones during surgery under regional anaesthesia.
Participants remained awake without routine intravenous sedation, although rescue sedation could be administered when clinically required.
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有源比较器：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.
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Participants received intravenous propofol sedation by target-controlled infusion during surgery under regional anaesthesia.
Sedation was titrated according to clinical assessment using Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (mOAA/S) monitoring.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
大体时间：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
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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.
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in Anxiety Visual Analogue Scale (VAS) Score
大体时间：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
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Anxiety was assessed using a Visual Analogue Scale (VAS) ranging from 1 (least anxious) to 10 (most anxious), with higher scores indicating greater anxiety.
The outcome was the change in VAS score from the preoperative to the postoperative assessment.
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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
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Intraoperative Bispectral Index (BIS)
大体时间：Every 10 minutes from the start of surgery until completion of surgery.
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Depth of sedation was assessed using the Bispectral Index (BIS).
BIS values were recorded at 10-minute intervals during surgery to assess the level of sedation during the assigned intervention.
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Every 10 minutes from the start of surgery until completion of surgery.
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Intraoperative Level of Sedation Measured by Modified Observer's Assessment of Alertness/Sedation (mOAA/S)
大体时间：Every 10 minutes from the start of surgery until completion of surgery.
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Alertness and sedation were assessed using the modified Observer's Assessment of Alertness/Sedation (mOAA/S) scale, ranging from 0 to 5. A score of 5 indicates that the participant is alert and responds readily to their name spoken in a normal tone, whereas a score of 0 indicates no response to a painful trapezius squeeze.
Higher scores therefore indicate greater alertness and lower levels of sedation.
mOAA/S was assessed at 10-minute intervals during surgery.
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Every 10 minutes from the start of surgery until completion of surgery.
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Intraoperative Systolic Blood Pressure
大体时间：Every 10 minutes from the start of surgery until completion of surgery.
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Systolic blood pressure was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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Every 10 minutes from the start of surgery until completion of surgery.
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Intraoperative Diastolic Blood Pressure
大体时间：Every 10 minutes from the start of surgery until completion of surgery
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Diastolic blood pressure was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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Every 10 minutes from the start of surgery until completion of surgery
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Intraoperative Heart Rate
大体时间：Every 10 minutes from the start of surgery until completion of surgery
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Heart rate was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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Every 10 minutes from the start of surgery until completion of surgery
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Postoperative Patient Satisfaction
大体时间：Postoperative period: During assessment in the post-anaesthesia recovery room, on the same day of surgery
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Overall satisfaction with the intervention provided during surgery was assessed using a verbal numerical rating scale ranging from 1 (least satisfied) to 10 (most satisfied), with higher scores indicating greater satisfaction.
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Postoperative period: During assessment in the post-anaesthesia recovery room, on the same day of surgery
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合作者和调查者
调查人员
- 首席研究员：MOHD FITRY BIN ZAINAL ABIDIN、University of Malaya
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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其他研究编号
- 2023418-12366
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