个性化音乐与丙泊酚镇静期间的梦境
个性化音乐增加异丙酚镇静期间的梦境：一项比较偏好音乐、匹配非偏好音乐和静默的随机试验
Many patients report dreams during intravenous (IV) propofol sedation, but it is uncertain whether listening to music changes how often dreams occur or how pleasant they feel. This single-center randomized study compared three auditory conditions during propofol sedation for elective surgery under spinal anesthesia or peripheral nerve block: (1) patient-selected preferred music, (2) matched non-preferred music, and (3) silence (headphones only). Music or silence was delivered through identical closed-back headphones starting 1-2 minutes before sedation and continuing until the end of sedation.
The main outcomes were (1) whether a dream occurred (yes/no) assessed by a neutral modified Brice interview in the post-anesthesia care unit (PACU), and (2) dream pleasantness rated on a 0-10 scale among participants who reported a dream. Additional outcomes included coded dream content features, patient satisfaction, sedative dose, hemodynamic variability, early recovery measures, postoperative symptoms, and adverse events.
研究概览
地位
详细说明
This is a single-center, parallel-group, three-arm randomized controlled trial evaluating the effects of auditory stimulation and music personalization on dreaming during IV propofol sedation. Adults (≥19 years) undergoing elective procedures under spinal anesthesia or peripheral nerve block with propofol sedation were eligible (ASA I-III). Participants were excluded for planned general anesthesia, severe hearing impairment, major psychiatric instability, expected significant bleeding, inability to complete interviews, or contraindication to sedative agents.
Randomization and blinding: Participants were randomized 1:1:1 to Preferred Music, Matched Non-preferred Music, or Silence using computerized randomization with variable block sizes, stratified by procedure category and preoperative anxiety (STAI-State tertiles). Allocation was concealed. An audio technician (non-assessor) set up the assigned condition. PACU interviewers, dream-content coders, and statisticians were blinded. Standardized closed-back headphones were used for all groups, with scripted staff interactions and calibrated volume (50-60 dB(A)) to support blinding; blinding integrity was assessed by questionnaire.
Interventions:
• Preferred Music: Participants selected one personally meaningful track preoperatively. The track was played continuously on loop through closed-back headphones starting 1-2 minutes before sedative infusion and continued until the end of sedation.
Final-The effect of Auditory St…
- Matched Non-preferred Music: Participants listened to a pleasant non-selected track matched to the preferred selection for tempo (±10 bpm), genre family, and loudness to separate preference effects from acoustic features; playback timing was identical.
- Silence Control: Participants wore identical headphones for the same duration without audio playback.
Sedation protocol and monitoring: Propofol was administered per a standardized regimen (initial bolus 0.5-1 mg/kg followed by infusion 25-75 µg/kg/min) titrated to maintain BIS 65-85. Sedation depth was assessed using MOAA/S (primary) and RASS (secondary), with routine physiologic monitoring and supplemental oxygen.
Outcomes: Co-primary outcomes were (1) dream incidence (yes/no) assessed by a neutral modified Brice interview in PACU, with the primary contrast of Music-pooled (Preferred or Non-preferred) versus Silence; and (2) dream pleasantness (0-10 numeric scale) among recallers, with the primary contrast of Preferred versus Matched Non-preferred music. PACU interview timing used prespecified readiness criteria and was initiated at approximately 15 minutes (±5) after PACU arrival, repeated every 5-10 minutes if needed up to 60 minutes. Secondary outcomes included blinded coded dream content features, patient satisfaction, sedative dose, hemodynamic variability, recovery endpoints (e.g., Aldrete-based recovery and PACU length of stay), postoperative symptoms (pain, nausea/vomiting, shivering), and adverse events.
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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Iksan、韩国、54538
- IRB of Wonkwnag University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged ≥ [19] years and ≤ [70] years.
- Scheduled for an elective procedure under intravenous propofol sedation at Wonkwang University Hospital.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Known hearing impairment that would interfere with headphone-based auditory intervention.
- Pre-existing cognitive impairment or delirium at baseline (e.g., diagnosed dementia or active delirium).
- Use of sedatives, hypnotics, or psychoactive medications that could confound dreaming assessment, per protocol.
- Significant neurologic or psychiatric disorder that may affect dream recall/reporting.
- Inability to complete the postoperative PACU interview or inability to communicate reliably.
- Any condition judged by the investigator to make participation unsafe or data uninterpretable.
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：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Preferred Music
Participants listen to their self-selected preferred music through standardized closed-back headphones during intravenous propofol sedation. Music starts at the beginning of sedation and continues until the end of the procedure/recovery period per protocol. |
Standardized closed-back headphones are used to deliver music during IV propofol sedation. Depending on randomization, participants receive self-selected preferred music. Playback begins shortly before sedation and continues until the end of sedation; volume is calibrated per protocol. |
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实验性的：Matched Non-Preferred Music
Participants listen to non-preferred music matched to the preferred-music selection (e.g., comparable tempo/energy/genre characteristics) through standardized closed-back headphones during intravenous propofol sedation. Playback timing and volume are standardized as in the preferred-music arm. |
Standardized closed-back headphones are used to deliver music during IV propofol sedation. Depending on randomization, participants receive e matched non-preferred music. Playback begins shortly before sedation and continues until the end of sedation; volume is calibrated per protocol. |
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安慰剂比较：Silence (Headphones Only)
Participants wear standardized closed-back headphones during intravenous propofol sedation, but no audio is played (silence condition). Procedures, timing, and staff interactions are otherwise identical to the music arms. |
Participants wear identical closed-back headphones during IV propofol sedation, but no audio is played. Procedures, timing, and staff interactions are otherwise identical to the music arms. |
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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Dream Incidence (Yes/No) by Modified Brice Interview
大体时间：PACU: primary at 15 minutes (±5) after arrival; if not ready, repeated every 5-10 minutes up to 60 minutes (first valid interview within 60 minutes).
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Dream occurrence (yes/no) assessed using a neutral modified Brice interview during early recovery in the PACU. Primary comparison: Music-pooled (Preferred or Non-preferred) vs Silence. |
PACU: primary at 15 minutes (±5) after arrival; if not ready, repeated every 5-10 minutes up to 60 minutes (first valid interview within 60 minutes).
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Dream Pleasantness (0-10 Numeric Rating Scale) Among Recallers
大体时间：Same PACU interview window as above: 15 minutes (±5) after PACU arrival; repeated every 5-10 minutes up to 60 minutes until readiness is met (first valid interview within 60 minutes).
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Dream pleasantness rated on a 0-10 Dream Pleasantness Numeric Rating Scale (minimum 0, maximum 10), where higher scores indicate more pleasant dreams (0 = not pleasant at all, 10 = extremely pleasant). |
Same PACU interview window as above: 15 minutes (±5) after PACU arrival; repeated every 5-10 minutes up to 60 minutes until readiness is met (first valid interview within 60 minutes).
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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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Dream Content Metrics (Blinded Coding) Among Recallers
大体时间：PACU interview window: first valid interview within 60 minutes after PACU arrival.
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Among participants with dream recall, dream content is assessed using prespecified blinded coding. Metrics include: (a) music-thematic incorporation (present/absent); (b) auditory salience score (0-3; 0 = none, 3 = strong; higher scores indicate greater auditory incorporation); (c) affect valence score (-2 to +2; -2 = very negative, +2 = very positive; higher scores indicate more positive affect); (d) vividness score (0-10; 0 = not vivid, 10 = extremely vivid; higher scores indicate more vivid dreams); and (e) sense of control/agency score (0-10; 0 = no control, 10 = complete control; higher scores indicate greater perceived control/agency). Narratives are double-coded with adjudication for disagreements. |
PACU interview window: first valid interview within 60 minutes after PACU arrival.
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Patient Satisfaction (1-5 Scale)
大体时间：PACU (early recovery; within the PACU assessment period).
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Patient satisfaction is assessed during early recovery in the PACU using a 5-point Likert satisfaction scale (minimum 1, maximum 5), where higher scores indicate greater satisfaction (1 = very dissatisfied, 5 = very satisfied). |
PACU (early recovery; within the PACU assessment period).
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Intraoperative Mean Arterial Pressure Variability (Standard Deviation)
大体时间：During sedation (intraoperative period).
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Variability in mean arterial pressure (MAP) is quantified as the standard deviation (SD) of continuously recorded MAP values during the propofol sedation period. Unit: mmHg. Higher SD indicates greater blood pressure variability. as standard deviation during the sedation period. |
During sedation (intraoperative period).
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Intraoperative Heart Rate Variability (Standard Deviation)
大体时间：During sedation (intraoperative period).
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Variability in heart rate (HR) is quantified as the standard deviation (SD) of continuously recorded HR values during the propofol sedation period. Unit: beats per minute (bpm). Higher SD indicates greater heart rate variability. |
During sedation (intraoperative period).
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Total Propofol Dose Administered
大体时间：During procedure and immediate recovery period.
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Total propofol administered during the procedure is recorded. Dose is expressed as mg/kg (weight-adjusted total dose). Higher values indicate greater propofol exposure. |
During procedure and immediate recovery period.
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Total Opioid Consumption (Morphine Milligram Equivalents)
大体时间：During procedure and immediate recovery period.
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Total opioid consumption during the procedure and immediate recovery is converted to morphine milligram equivalents (MME) and recorded in mg. Higher values indicate greater opioid exposure |
During procedure and immediate recovery period.
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Vasopressor Use (Yes/No)
大体时间：During procedure and immediate recovery period.
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Any vasopressor administration during the procedure and immediate recovery is recorded as yes/no. Higher values (yes) indicate that vasopressor support was required. |
During procedure and immediate recovery period.
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Time to Recovery (Aldrete Score ≥ 9) and PACU Length of Stay
大体时间：From PACU arrival until discharge criteria met / PACU discharge.
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Time to achieve Aldrete score ≥9 and total PACU time (minutes). |
From PACU arrival until discharge criteria met / PACU discharge.
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Postoperative Pain Intensity (0-10 Numeric Rating Scale)
大体时间：PACU stay (early recovery).
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Postoperative pain intensity is assessed during early recovery in the PACU using a 0-10 Numeric Rating Scale (NRS; minimum 0, maximum 10), where higher scores indicate worse pain (0 = no pain, 10 = worst imaginable pain). |
PACU stay (early recovery).
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Postoperative Nausea and Vomiting Severity (0-3 Ordinal Scale)
大体时间：PACU stay (early recovery).
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Postoperative nausea and vomiting (PONV) severity is assessed during early recovery in the PACU using a 0-3 ordinal PONV severity scale (minimum 0, maximum 3), where higher scores indicate worse symptoms (0 = none, 1 = mild nausea, 2 = moderate/severe nausea or retching, 3 = vomiting). |
PACU stay (early recovery).
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Postoperative Shivering (Yes/No)
大体时间：PACU stay (early recovery).
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Postoperative shivering during early recovery in the PACU is recorded as present/absent (yes/no). |
PACU stay (early recovery).
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Unplanned Hospital Admission (Yes/No)
大体时间：From procedure start through PACU discharge.
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Any unplanned hospital admission from procedure start through PACU discharge is recorded as yes/no (higher = yes indicates admission occurred). |
From procedure start through PACU discharge.
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dverse Events (Number of Events)
大体时间：From procedure start through PACU discharge.
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The total number of adverse events occurring from procedure start through PACU discharge is recorded per protocol (higher values indicate more events). |
From procedure start through PACU discharge.
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Any Adverse Event (Yes/No)
大体时间：From procedure start through PACU discharge.
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Occurrence of any adverse event from procedure start through PACU discharge is recorded as yes/no (higher = yes indicates an event occurred). |
From procedure start through PACU discharge.
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合作者和调查者
调查人员
- 首席研究员：Cheol Lee, M.D.,Ph.D、Department of anesthesiology and pain medicine, Wonkwang University Hospital
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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