Conscious SedationNCT07389954
Personalized Music and Dreaming During Propofol Sedation
A study testing Preferred Music, Matched Non-Preferred Music and Silence (Headphones Only) in people with Conscious Sedation and Propofol, run by Wonkwang University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Conscious Sedation, Propofol, Dreams
- What is being tested?
- Preferred Music, Matched Non-Preferred Music and Silence (Headphones Only)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2025to 16 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Music Increases Dreaming During Propofol Sedation: A Randomized Trial Comparing Preferred Music, Matched Non-Preferred Music, and Silence
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.
Read the 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
- Being tested
- Preferred Music, Matched Non-Preferred Music, Silence (Headphones Only)
- Keywords
- Procedural Sedation, Intravenous Sedation, Personalized Music, Preferred Music, Dream Recall, Dream Pleasantness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preferred MusicBehavioural
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.
Matched Non-Preferred MusicBehavioural
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.
Silence (Headphones Only)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Silence (Headphones Only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Among participants with dream recall, dream content is assessed using prespecified blinded coding. Metrics include: (a) music-thematic incorporation (present/absent); (b) auditory salience score (0-3; 0 = none, 3 = strong; higher scores indicate greater auditory incorporation); (c) affect valence score (-2 to +2; -2 = very negative, +2 = very positive; higher scores indicate more positive affect); (d) vividness score (0-10; 0 = not vivid, 10 = extremely vivid; higher scores indicate more vivid dreams); and (e) sense of control/agency score (0-10; 0 = no control, 10 = complete control; higher scores indicate greater perceived control/agency). Narratives are double-coded with adjudication for disagreements.
Measured: PACU interview window: first valid interview within 60 minutes after PACU arrival.
Patient Satisfaction (1-5 Scale)
Patient satisfaction is assessed during early recovery in the PACU using a 5-point Likert satisfaction scale (minimum 1, maximum 5), where higher scores indicate greater satisfaction (1 = very dissatisfied, 5 = very satisfied).
Measured: PACU (early recovery; within the PACU assessment period).
Intraoperative Mean Arterial Pressure Variability (Standard Deviation)
Variability in mean arterial pressure (MAP) is quantified as the standard deviation (SD) of continuously recorded MAP values during the propofol sedation period. Unit: mmHg. Higher SD indicates greater blood pressure variability. as standard deviation during the sedation period.
Measured: During sedation (intraoperative period).
Intraoperative Heart Rate Variability (Standard Deviation)
Variability in heart rate (HR) is quantified as the standard deviation (SD) of continuously recorded HR values during the propofol sedation period. Unit: beats per minute (bpm). Higher SD indicates greater heart rate variability.
Measured: During sedation (intraoperative period).
Total Propofol Dose Administered
Total propofol administered during the procedure is recorded. Dose is expressed as mg/kg (weight-adjusted total dose). Higher values indicate greater propofol exposure.
Measured: During procedure and immediate recovery period.
Total Opioid Consumption (Morphine Milligram Equivalents)
Total opioid consumption during the procedure and immediate recovery is converted to morphine milligram equivalents (MME) and recorded in mg. Higher values indicate greater opioid exposure
Measured: During procedure and immediate recovery period.
Vasopressor Use (Yes/No)
Any vasopressor administration during the procedure and immediate recovery is recorded as yes/no. Higher values (yes) indicate that vasopressor support was required.
Measured: During procedure and immediate recovery period.
Time to Recovery (Aldrete Score ≥ 9) and PACU Length of Stay
Time to achieve Aldrete score ≥9 and total PACU time (minutes).
Measured: From PACU arrival until discharge criteria met / PACU discharge.
Postoperative Pain Intensity (0-10 Numeric Rating Scale)
Postoperative pain intensity is assessed during early recovery in the PACU using a 0-10 Numeric Rating Scale (NRS; minimum 0, maximum 10), where higher scores indicate worse pain (0 = no pain, 10 = worst imaginable pain).
Measured: PACU stay (early recovery).
Postoperative Nausea and Vomiting Severity (0-3 Ordinal Scale)
Postoperative nausea and vomiting (PONV) severity is assessed during early recovery in the PACU using a 0-3 ordinal PONV severity scale (minimum 0, maximum 3), where higher scores indicate worse symptoms (0 = none, 1 = mild nausea, 2 = moderate/severe nausea or retching, 3 = vomiting).
Measured: PACU stay (early recovery).
Postoperative Shivering (Yes/No)
Postoperative shivering during early recovery in the PACU is recorded as present/absent (yes/no).
Measured: PACU stay (early recovery).
Unplanned Hospital Admission (Yes/No)
Any unplanned hospital admission from procedure start through PACU discharge is recorded as yes/no (higher = yes indicates admission occurred).
Measured: From procedure start through PACU discharge.
dverse Events (Number of Events)
The total number of adverse events occurring from procedure start through PACU discharge is recorded per protocol (higher values indicate more events).
Measured: From procedure start through PACU discharge.
Any Adverse Event (Yes/No)
Occurrence of any adverse event from procedure start through PACU discharge is recorded as yes/no (higher = yes indicates an event occurred).
Measured: From procedure start through PACU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start19 Dec 2025
- Primary completion16 Jan 2026
- Study completion16 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee,MD,PhD,, Wonkwang University Hospital
- Investigators
- Cheol Lee, M.D.,Ph.D, Principal investigator, Department of anesthesiology and pain medicine, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389954
- Sponsor's protocol ID
- Wonkwang UH 24
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No