Personalized Music, Dreaming During Propofol Sedation

NCT07638072 | Recruiting DMC

• 1 other identifier: Wonkwang UH26
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Procedural Sedation; Dreams

Keywords

Propofol; Sedation; Music; Dreaming; Auditory Stimulation; Patient Experience

Outcome Measures

Primary Outcomes (2)

• Dream Incidence

  Occurrence of dream recall after intravenous propofol sedation, assessed using a neutral modified Brice interview. Participants will be classified as having dream recall or no dream recall.

  At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival

• Dream Pleasantness

  Pleasantness of recalled dreams among participants who report dream recall, assessed using a 0 to 10 numeric rating scale, where higher scores indicate more pleasant dreams.

  At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival

Secondary Outcomes (5)

• Within 60 minutes after arrival in the post-anesthesia care unit

  At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival

• Affect Valence of Dream Content

  At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival

• Dream Vividness

  At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival

• Sense of Control in Dream

  At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival

• Patient Satisfaction With Sedation Experience

  Assessed once at discharge from the post-anesthesia care unit, approximately within 2 hours after completion of sedation

Study Arms (3)

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.

Behavioral: Preferred Music

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.

Behavioral: Matched Non-preferred Music

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.

Behavioral: Silence Control

Interventions

Preferred Music BEHAVIORAL

A personally selected music track will be played through closed-back headphones during intravenous propofol sedation.

Also known as: Patient-selected music Personalized music

Preferred Music

Matched Non-preferred Music BEHAVIORAL

A pleasant, non-selected music track matched by genre, tempo, and loudness will be played through closed-back headphones during intravenous propofol sedation.

Also known as: Matched music Non-selected music

Matched Non-preferred Music

Silence Control BEHAVIORAL

Participants will wear identical closed-back headphones during intravenous propofol sedation, but no audio will be played.

Also known as: Headphones without playback No-audio control

Silence Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwag UH

Iksan, Jeollabukdo, South Korea

RECRUITING

Study Officials

• Cheol Lee, M.D.,Ph.D

  Wonkwang University Hosptial

  STUDY DIRECTOR

Central Study Contacts

Cheol Lee, M.D.,Ph.D.

CONTACT

01066131252; ironyii@wku.ac.kr

Cheolhyeong Lee, M.D.,Ph.D

CONTACT

01077369397; cheolhyeonglee@naver.com

Study Design

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

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: preferred music, matched non-preferred music, or silence control. All participants will receive intravenous propofol sedation during elective procedures under spinal anesthesia or peripheral nerve block. The intervention will consist of the assigned auditory condition delivered through identical closed-back headphones during the sedation period.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 10, 2026
• Study Start: June 24, 2026
• Primary Completion: July 20, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

KR (1)