NCT07389954

Personalized Music and Dreaming During Propofol Sedation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Wonkwang University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Conscious Sedation
• Propofol
• Dreams

Interventions

Type	Name	Description
BEHAVIORAL	Preferred Music	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.
BEHAVIORAL	Matched Non-Preferred Music	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.
BEHAVIORAL	Silence (Headphones Only)	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.

Timeline

• Start date: 2025-12-19
• Primary completion: 2026-01-16
• Completion: 2026-01-16
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: South Korea