Personalized Music and Dreaming During Propofol Sedation

NCT07389954 | Completed DMC

• 1 other identifier: Wonkwang UH 24
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dreams; Propofol; Conscious Sedation

Keywords

Procedural Sedation; Intravenous Sedation; Personalized Music; Preferred Music; Dream Recall; Dream Pleasantness

Outcome Measures

Primary Outcomes (2)

• Dream Incidence (Yes/No) by Modified Brice Interview

  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).

• Dream Pleasantness (0-10 Numeric Rating Scale) Among Recallers

  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).

Secondary Outcomes (14)

• 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.

Study Arms (3)

Preferred Music

EXPERIMENTAL

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.

Behavioral: Preferred Music

Matched Non-Preferred Music

EXPERIMENTAL

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.

Behavioral: Matched Non-Preferred Music

Silence (Headphones Only)

PLACEBO COMPARATOR

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.

Behavioral: Silence (Headphones Only)

Interventions

Matched Non-Preferred Music BEHAVIORAL

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.

Matched Non-Preferred Music

Silence (Headphones Only) BEHAVIORAL

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.

Silence (Headphones Only)

Preferred Music BEHAVIORAL

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.

Preferred Music

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

IRB of Wonkwnag University Hospital

Iksan, 54538, South Korea

Location

Study Officials

• Cheol Lee, M.D.,Ph.D

  Department of anesthesiology and pain medicine, Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-center, parallel-group, three-arm randomized controlled trial. Participants were allocated 1:1:1 to Preferred Music, Matched Non-preferred Music, or Silence (headphones without playback) during IV propofol sedation.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 5, 2026
• Study Start: December 19, 2025
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

KR (1)