The Impact of Preoperative Suggestion on Dreaming
1 other identifier
interventional
250
1 country
1
Brief Summary
Recent studies have shown that positive preoperative suggestions can significantly influence the quality of dreams and reduce the incidence of unpleasant dreams during sedation with agents like ketamine and propofol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2024
CompletedFirst Submitted
Initial submission to the registry
September 22, 2024
CompletedFirst Posted
Study publicly available on registry
September 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedFebruary 25, 2025
February 1, 2025
2 months
September 22, 2024
February 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Dreaming
The "Dreaming and Cognition Evaluation Questionnaire" will be used.questionnaire evaluates the incidence of dreaming, as well as the dream's content, emotional tone (rated on a 1-5 scale from very unpleasant to very pleasant), memorability, visual vividness, intensity, and other qualitative aspects such as sound, movement, and emotional significance.
Dreaming will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU).
Quality of Dreaming
The "Dreaming and Cognition Evaluation Questionnaire" will be used. This questionnaire evaluates the incidence of dreaming, as well as the dream's content, emotional tone (rated on a 1-5 scale from very unpleasant to very pleasant), memorability, visual vividness, intensity, and other qualitative aspects such as sound, movement, and emotional significance.
Dreaming will be assessed immediately in the Post-Anesthesia Care Unit (PACU).
Secondary Outcomes (2)
Satisfaction with Care
Satisfaction will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU)
Adverse events
Monitoring will be continuous with regular vital signs recorded every 5 minutes during surgery and every 15 minutes in the PACU.
Study Arms (4)
Control Group with Propofol
ACTIVE COMPARATORReceives standard preoperative instructions and propofol infusion.
Suggestion Group with Propofol
EXPERIMENTALReceives positive preoperative suggestions and propofol infusion.
Control Group with Ketamine
ACTIVE COMPARATORReceives standard preoperative instructions and ketamine infusion.
Suggestion Group with Ketamine
EXPERIMENTALReceives positive preoperative suggestions and ketamine infusion.
Interventions
Receives standard preoperative instructions and propofol or ketamine infusion.
Receives positive preoperative suggestions and propofol or ketamine infusion.
Eligibility Criteria
You may qualify if:
- Adult patients aged 20-65 years.
- ASA physical status I-III.
- Scheduled for elective spinal anesthesia or brachial plexus block.
- Fluent in Korean.
You may not qualify if:
- Use of any medication, including premedication, within 12 hours before surgery.
- Cognitive impairments or psychiatric disorders (including a history of unpleasant dreams or nightmares).
- Current use of sedatives or hypnotics.
- History of severe or recurrent nightmares.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WonwangUH
Iksan, Please Select, 54538, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cheol Lee, M.D.,Ph.D
Wonkwang University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, M.D., Ph.D
Study Record Dates
First Submitted
September 22, 2024
First Posted
September 24, 2024
Study Start
September 19, 2024
Primary Completion
November 25, 2024
Study Completion
January 30, 2025
Last Updated
February 25, 2025
Record last verified: 2025-02