Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery

Not Applicable

Recruiting

• Conditions: Shivering; Spinal Anesthesia

• Registration Number: NCT06708169
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The goal of this study is to learn about the effect of preemptive education on reducing intraoperative maternal shivering in elective cesarean delivery. The main question it aims to answer is:

Does preemptive education by anesthesiologists reduce intraoperative maternal shivering in elective cesarean delivery?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-11-24
• Study First Posted: 2024-11-27
• Study Start: 2024-12-09
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-02-28
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Age 19 years or older
• Gestational age 37 weeks or above
• Elective surgey

Exclusion Criteria

• Emergency surgery
• Any sign of onset of labor
• Difficulty with communication
• Contraindications of spinal anesthesia
• Pre-eclampsia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with intraoperative maternal shivering	From the moment the patient enters the operating room (0 minute) until leaving the operating room on the same day, expected to be up to 180 minutes.	Record when shivering occurred within the time frame

Secondary Outcome Measures

Name	Time	Method
Obstetric quality of recovery until post-operative day 1	At 24 hours after surgery	Quality of recovery will be assessed by Obstetric Quality of Recovery-11K survery, which is a questionnaire completed by participants.; Higher score means higher quality of recovery.
Intraoperative body temperature	0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after entering the operating room until the end of surgery.
Intraoperative pain (Numeric rating scale, NRS).	From the moment the patient enters the operating room (0 minute) until leaving the operating room on the same day, expected to be up to 180 minutes.	NRS 0: no pain 1-3: mild pain (nagging, annoying, interfering little with acitivities of daily living (ADLs)) 4-6: moderate Pain (interferes significantly with ADLs) 7-10: severe Pain (disabling; unable to perform ADLs); Record when the patient complained pain within the time frame
Spinal anesthesia level (dermatome)	From the intrathecal injection (0 minute) until at the end of surgery (0, 5, 10, 25, 40, 55, 75 minute, at the end of surgery)
Post-operative spinal anesthesia level in recovery room	From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room)	The level(dermatome) of spinal anesthesia will be checked by pin-prick test by an anesthesiologist or nurse.
Number of Participants with Post-operative shivering in recovery room	From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room)
Post-operative body temperature in recovery room	From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room)
Post-operative nausea and vomiting in recovery room (by questionnaire)	From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room)	Nausea and vomiting will be assessed by questionnaire. (yes/no)
Patient's satisfaction by questionnaire	From the end of surgery until 24 hours after surgery	Patient's satisfaction about pre-operative preparation, anesthesia, and surgery by questionnaire.; Participants will respond their satisfaction by score 0-10. (A higher score means higher satisfaction. )
Pain (assessed by NRS) until post-operative day 1	At 6, 12, 18, 24 hours after the end of surgery	NRS (numeric rating scale) is detailed at Outcome number 3.
Analgesic dosage (Morphile miligram equivalents) until post-operative day 1	From the end of surgery until 24 hours after surgery

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of