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

NCT06708169 | Recruiting

• 1 other identifier: 2408-040-1558
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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?

Conditions

Shivering; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of participants with intraoperative maternal shivering

  Record when shivering occurred within the time frame

  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.

Secondary Outcomes (11)

• 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.

• 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)

• 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)

Study Arms (2)

Patients without preoperative education by anesthesiologists

NO INTERVENTION

Patients get minimal information about the surgical process and their questions will be answered by obstetrician.

Patients with preoperative education by anesthesiologists

EXPERIMENTAL

Patients get preemptive education about the whole process from anesthesia to recovery stage within 15 minute by anesthesiologists.

Behavioral: preemptive education provided by anesthesiologists

Interventions

preemptive education provided by anesthesiologists BEHAVIORAL

A preemptive education about 4 stages (prepare, anethesia, surgery, and recovery) by anesthesiologists within 15 minute.

Patients with preoperative education by anesthesiologists

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Central Study Contacts

Jang

CONTACT

821025640576; wwdzhl55@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 27, 2024
• Study Start: December 9, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2024-09

Locations

KR (1)