ClinicalTrials.Veeva

Menu

Personalized Music and Dreaming During Propofol Sedation

W

Wonkwang University Hospital

Status

Completed

Conditions

Propofol
Conscious Sedation
Dreams

Treatments

Behavioral: Silence (Headphones Only)
Behavioral: Matched Non-Preferred Music
Behavioral: Preferred Music

Study type

Interventional

Funder types

Other

Identifiers

NCT07389954
Wonkwang UH 24

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

300 participants in 3 patient groups, including a placebo group

Preferred Music
Experimental group
Description:
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.
Treatment:
Behavioral: Preferred Music
Matched Non-Preferred Music
Experimental group
Description:
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.
Treatment:
Behavioral: Matched Non-Preferred Music
Silence (Headphones Only)
Placebo Comparator group
Description:
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.
Treatment:
Behavioral: Silence (Headphones Only)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems