Actively Recruiting
Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery: a Randomized Controlled Trial
Led by Seoul National University Hospital · Updated on 2025-05-15
130
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to investigate whether providing preemptive education by anesthesiologists can reduce the occurrence of maternal shivering during elective cesarean delivery. The study focuses on women undergoing this specific surgical procedure and seeks to answer if informing patients ahead of time about the anesthesia and surgery process affects intraoperative shivering. The trial is randomized and triple-blinded to ensure unbiased results and is sponsored by Seoul National University Hospital. Participants are divided into two groups: one group receives minimal information about the surgery with questions answered by the obstetrician, while the other group receives detailed preemptive education about the entire process—from anesthesia through recovery—provided by anesthesiologists in a 15-minute session. The study compares the effect of this education on maternal shivering during surgery. During the study, researchers will monitor participants from the moment they enter the operating room until they leave, which may last up to 180 minutes. They will measure the number of women experiencing shivering, body temperature, pain levels, and spinal anesthesia effects at various time points during and after surgery. Additional assessments include post-operative shivering, nausea, patient satisfaction, pain and analgesic use up to one day after surgery, and obstetric recovery quality. This thorough monitoring helps evaluate the full impact of preemptive education on the surgery experience and recovery.
CONDITIONS
Brief Title
Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Gestational age 37 weeks or above
- Elective cesarean surgery planned
You will not qualify if you...
- Emergency surgery
- Any sign of onset of labor
- Difficulty with communication
- Contraindications of spinal anesthesia
- Pre-eclampsia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 180 minutes on the day of surgery
Participants receive preemptive education about the anesthesia, surgery, and recovery process by anesthesiologists within 15 minutes before the elective cesarean delivery.
1 visit (in-person) during the surgery day
Duration - From surgery end until 24 hours post-surgery
Participants are monitored in the recovery room for shivering, temperature, nausea, and pain, with assessments continuing up to 24 hours after surgery including patient satisfaction and analgesic use.
Approximately 1 recovery room visit plus follow-up assessments up to 24 hours
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 03080
Actively Recruiting
Research Team
J
Jang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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