Personalized Music Increases Dreaming During Propofol Sedation: A Randomized Trial Comparing Preferred Music, Matched Non-Preferred Music, and Silence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Dream Incidence (Yes/No) by Modified Brice Interview
研究概览
简要总结
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.
详细描述
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…
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation was concealed and managed by a non-assessor audio technician. Standardized closed-back headphones were used in all arms (silence arm without playback). PACU interviewers, content coders, and statisticians were blinded to group assignment; scripted interactions and volume calibration supported blinding.
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Preferred Music (Behavioral)
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.
干预措施: Matched Non-Preferred Music (Behavioral)
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.
干预措施: Silence (Headphones Only) (Behavioral)
结局指标
主要结局
Dream Incidence (Yes/No) by Modified Brice Interview
时间窗: 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).
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.
Dream Pleasantness (0-10 Numeric Rating Scale) Among Recallers
时间窗: 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).
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).
次要结局
- Dream Content Metrics (Blinded Coding) Among Recallers(PACU interview window: first valid interview within 60 minutes after PACU arrival.)
- Patient Satisfaction (1-5 Scale)(PACU (early recovery; within the PACU assessment period).)
- Intraoperative Mean Arterial Pressure Variability (Standard Deviation)(During sedation (intraoperative period).)
- Intraoperative Heart Rate Variability (Standard Deviation)(During sedation (intraoperative period).)
- Total Propofol Dose Administered(During procedure and immediate recovery period.)
- Total Opioid Consumption (Morphine Milligram Equivalents)(During procedure and immediate recovery period.)
- Vasopressor Use (Yes/No)(During procedure and immediate recovery period.)
- Time to Recovery (Aldrete Score ≥ 9) and PACU Length of Stay(From PACU arrival until discharge criteria met / PACU discharge.)
- Postoperative Pain Intensity (0-10 Numeric Rating Scale)(PACU stay (early recovery).)
- Postoperative Nausea and Vomiting Severity (0-3 Ordinal Scale)(PACU stay (early recovery).)
- Postoperative Shivering (Yes/No)(PACU stay (early recovery).)
- Unplanned Hospital Admission (Yes/No)(From procedure start through PACU discharge.)
- dverse Events (Number of Events)(From procedure start through PACU discharge.)
- Any Adverse Event (Yes/No)(From procedure start through PACU discharge.)
研究者
Cheol Lee,MD,PhD,
Professor
Wonkwang University Hospital