Personalized Music, Dreaming During Propofol Sedation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorWonkwang University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Preferred Music
BehavioralA personally selected music track will be played through closed-back headphones during intravenous propofol sedation.
Matched Non-preferred Music
BehavioralA pleasant, non-selected music track matched by genre, tempo, and loudness will be played through closed-back headphones during intravenous propofol sedation.
Silence Control
BehavioralParticipants will wear identical closed-back headphones during intravenous propofol sedation, but no audio will be played.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Preferred MusicExperimental treatment 1 intervention
Group B: Matched Non-preferred MusicActive comparator 1 intervention
Group C: Silence ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival2
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.
Time frame
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrivalSecondary outcomes
1
Within 60 minutes after arrival in the post-anesthesia care unit
Degree of auditory salience in recalled dream content, assessed by blinded content coders using a 0 to 3 scale, where higher scores indicate greater auditory salience.
Time frame
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival2
Affect Valence of Dream Content
Emotional valence of recalled dream content, assessed by blinded content coders using a scale from -2 to +2, where higher scores indicate more positive affect.
Time frame
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival3
Dream Vividness
Vividness of recalled dreams, assessed using a 0 to 10 numeric rating scale, where higher scores indicate more vivid dream experiences.
Time frame
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival4
Sense of Control in Dream
Participant-reported sense of control or agency within the recalled dream, assessed using a 0 to 10 numeric rating scale, where higher scores indicate greater perceived control.
Time frame
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrivalSponsors and contacts
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Source ClinicalTrials.gov