- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07638072
Personalized Music, Dreaming During Propofol Sedation
Personalized Music Increases Dreaming During Propofol Sedation: A Randomized Trial Comparing Preferred Music, Matched Non-preferred Music, and Silence
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.
Přehled studie
Postavení
Podmínky
Detailní popis
Dreaming during intravenous propofol sedation is common and may influence how patients remember their perioperative experience. External auditory stimulation can sometimes be processed during sedation and may be incorporated into dream content. Music is a practical auditory intervention because it can be delivered through headphones without interfering with anesthetic care or the surgical workflow. However, it remains unclear whether music itself increases dream recall during propofol sedation, and whether patient-selected music provides additional benefit beyond exposure to music with similar acoustic features.
The modified Brice interview will be administered as soon as the participant has adequately recovered consciousness and is able to communicate in the PACU. Because dream recall may fade over time, the interview will be conducted at the earliest feasible time point after recovery of consciousness and no later than 60 minutes after PACU arrival.
This single-center, parallel-group, three-arm randomized controlled trial will compare three auditory conditions during propofol sedation: preferred music, matched non-preferred music, and silence. Participants assigned to the preferred music group will listen to one personally selected track through closed-back headphones. Participants assigned to the matched non-preferred music group will listen to a pleasant but non-selected track matched to the preferred music by genre family, tempo, and loudness. Participants assigned to the silence control group will wear identical closed-back headphones without music playback. In all groups, the assigned auditory condition will begin shortly before sedative administration and continue until the end of the sedation period.
The study population will consist of adults undergoing elective procedures under spinal anesthesia or peripheral nerve block with intravenous propofol sedation. Propofol sedation will be administered according to a standardized protocol and titrated to a predefined sedation depth using clinical sedation scales, with processed electroencephalographic monitoring recorded when available. Standard intraoperative monitoring will be performed according to institutional anesthetic practice.
The study has two main comparisons. First, the two music groups will be pooled and compared with the silence group to assess whether auditory stimulation increases dream recall. Second, the preferred music group will be compared with the matched non-preferred music group to assess whether personalization improves dream pleasantness among participants who recall dreams. Dream recall and dream pleasantness will be assessed in the post-anesthesia care unit using a standardized, neutral interview after participants meet predefined recovery-readiness criteria.
Additional assessments will include coded dream content, auditory salience, emotional valence, vividness, perceived control within the dream, patient satisfaction, propofol dose, opioid use, hemodynamic variability, recovery time, postoperative pain, postoperative nausea and vomiting, and adverse events. Dream narratives will be coded by blinded assessors using a prespecified codebook. Outcome assessors, content coders, and statisticians will remain blinded to group allocation whenever feasible.
The overall aim is to determine whether structured headphone-based music, particularly patient-preferred music, can improve the subjective quality of propofol sedation while maintaining clinical safety. The findings may inform whether routine music delivery and optional music preference capture should be incorporated into perioperative sedation workflows.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Cheol Lee, M.D.,Ph.D.
- Telefonní číslo: 01066131252
- E-mail: ironyii@wku.ac.kr
Studijní záloha kontaktů
- Jméno: Cheolhyeong Lee, M.D.,Ph.D
- Telefonní číslo: 01077369397
- E-mail: cheolhyeonglee@naver.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Preferred Music
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.
|
A personally selected music track will be played through closed-back headphones during intravenous propofol sedation.
Ostatní jména:
|
|
Aktivní komparátor: Matched Non-preferred Music
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.
|
A pleasant, non-selected music track matched by genre, tempo, and loudness will be played through closed-back headphones during intravenous propofol sedation.
Ostatní jména:
|
|
Falešný srovnávač: Silence Control
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.
|
Participants will wear identical closed-back headphones during intravenous propofol sedation, but no audio will be played.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Dream Incidence
Časové okno: At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
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
Časové okno: At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Within 60 minutes after arrival in the post-anesthesia care unit
Časové okno: At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
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.
|
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
|
Affect Valence of Dream Content
Časové okno: At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
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.
|
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
|
Dream Vividness
Časové okno: At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
Vividness of recalled dreams, assessed using a 0 to 10 numeric rating scale, where higher scores indicate more vivid dream experiences.
|
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
|
Sense of Control in Dream
Časové okno: At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
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.
|
At first adequate recovery of consciousness in the post-anesthesia care unit, up to 60 minutes after PACU arrival
|
|
Patient Satisfaction With Sedation Experience
Časové okno: Assessed once at discharge from the post-anesthesia care unit, approximately within 2 hours after completion of sedation
|
Participant satisfaction with the sedation experience will be assessed using a 5-point Patient Satisfaction Scale, ranging from 1 to 5. A score of 1 indicates very dissatisfied, and a score of 5 indicates very satisfied.
Higher scores indicate greater satisfaction with the sedation experience.
|
Assessed once at discharge from the post-anesthesia care unit, approximately within 2 hours after completion of sedation
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Cheol Lee, M.D.,Ph.D, Wonkwang University Hosptial
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Wonkwang UH26
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