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临床试验/NCT07638072
NCT07638072已完成不适用

Personalized Music Increases Dreaming During Propofol Sedation: A Randomized Trial Comparing Preferred Music, Matched Non-preferred Music, and Silence

Wonkwang University Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年6月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2

研究概览

简要总结

This randomized clinical trial will evaluate whether music delivered through closed-back headphones during intravenous propofol sedation affects dreaming and the overall sedation experience. Adults scheduled for elective procedures under spinal anesthesia or peripheral nerve block with propofol sedation will be randomly assigned to one of three groups: patient-selected preferred music, matched non-preferred music, or silence with identical headphones.

The main purpose of the study is to determine whether listening to music increases the occurrence of dream recall compared with silence, and whether personally preferred music makes recalled dreams more pleasant than matched non-preferred music. Dream recall and dream pleasantness will be assessed after recovery using a standardized interview. The study will also evaluate dream content, patient satisfaction, sedative and opioid requirements, hemodynamic variability, postoperative pain, nausea and vomiting, recovery time, and adverse events.

This study is intended to determine whether a simple, low-cost headphone-based music intervention can improve patient-centered quality of propofol sedation without compromising safety.

详细描述

Dreaming during intravenous propofol sedation is common and may influence how patients remember their perioperative experience. External auditory stimulation can sometimes be processed during sedation and may be incorporated into dream content. Music is a practical auditory intervention because it can be delivered through headphones without interfering with anesthetic care or the surgical workflow. However, it remains unclear whether music itself increases dream recall during propofol sedation, and whether patient-selected music provides additional benefit beyond exposure to music with similar acoustic features.

The modified Brice interview will be administered as soon as the participant has adequately recovered consciousness and is able to communicate in the PACU. Because dream recall may fade over time, the interview will be conducted at the earliest feasible time point after recovery of consciousness and no later than 60 minutes after PACU arrival.

This single-center, parallel-group, three-arm randomized controlled trial will compare three auditory conditions during propofol sedation: preferred music, matched non-preferred music, and silence. Participants assigned to the preferred music group will listen to one personally selected track through closed-back headphones. Participants assigned to the matched non-preferred music group will listen to a pleasant but non-selected track matched to the preferred music by genre family, tempo, and loudness. Participants assigned to the silence control group will wear identical closed-back headphones without music playback. In all groups, the assigned auditory condition will begin shortly before sedative administration and continue until the end of the sedation period.

The study population will consist of adults undergoing elective procedures under spinal anesthesia or peripheral nerve block with intravenous propofol sedation. Propofol sedation will be administered according to a standardized protocol and titrated to a predefined sedation depth using clinical sedation scales, with processed electroencephalographic monitoring recorded when available. Standard intraoperative monitoring will be performed according to institutional anesthetic practice.

The study has two main comparisons. First, the two music groups will be pooled and compared with the silence group to assess whether auditory stimulation increases dream recall. Second, the preferred music group will be compared with the matched non-preferred music group to assess whether personalization improves dream pleasantness among participants who recall dreams. Dream recall and dream pleasantness will be assessed in the post-anesthesia care unit using a standardized, neutral interview after participants meet predefined recovery-readiness criteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Post-anesthesia care unit interviewers, dream-content coders, and statisticians will be blinded to group allocation. An audio technician who is not involved in outcome assessment will manage the headphone setup and music playback. Identical closed-back headphones and standardized scripted interactions will be used to minimize disclosure of group assignment.

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 19 years or older.
  • Scheduled to undergo an elective procedure under spinal anesthesia or peripheral nerve block with intravenous propofol sedation.
  • American Society of Anesthesiologists physical status I to III.
  • Able to provide written informed consent.
  • Able to wear closed-back headphones during the study period.
  • Able to complete postoperative interviews and study questionnaires.

排除标准

  • Planned general anesthesia.
  • Severe hearing impairment that would interfere with the auditory intervention.
  • Major psychiatric instability or condition that may interfere with study participation or dream assessment.
  • Expected significant intraoperative bleeding.
  • Inability to complete the required postoperative interviews or questionnaires.
  • Contraindication to propofol or other study sedative agents.
  • Refusal or withdrawal of informed consent.

研究组 & 干预措施

Silence Control

Sham Comparator

Participants assigned to this arm will wear identical closed-back headphones during intravenous propofol sedation, but no audio will be played. The headphones will be applied for the same period as in the music arms, beginning 1-2 minutes before sedative administration and continuing until the end of the sedation period. This arm controls for headphone use, attention, and expectancy without auditory stimulation.

干预措施: Silence Control (Behavioral)

Preferred Music

Experimental

Participants assigned to this arm will listen to one personally selected preferred music track through identical closed-back headphones during intravenous propofol sedation. Playback will begin 1-2 minutes before sedative administration and continue until the end of the sedation period. The track may include either lyrical or instrumental music according to participant preference.

干预措施: Preferred Music (Behavioral)

Matched Non-preferred Music

Active Comparator

Participants assigned to this arm will listen to one pleasant but non-selected music track through identical closed-back headphones during intravenous propofol sedation. The track will be matched to the participant's preferred music by genre family, tempo, and loudness, but it will not be personally selected by the participant. Playback will begin 1-2 minutes before sedative administration and continue until the end of the sedation period.

干预措施: Matched Non-preferred Music (Behavioral)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheol Lee,MD,PhD,

Professor

Wonkwang University Hospital

研究点 (2)

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