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

Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery: a Randomized Controlled Trial

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?

Study Overview

• Status: Recruiting
• Conditions: Spinal Anesthesia; Shivering
• Intervention / Treatment: Behavioral: preemptive education provided by anesthesiologists

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jang; Phone Number: 821025640576; Email: wwdzhl55@naver.com

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Hansol Kim, MD; Phone Number: +82220722467; Email: hansolfrkr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Patients without preoperative education by anesthesiologists; Patients get minimal information about the surgical process and their questions will be answered by obstetrician.
Experimental: Patients with preoperative education by anesthesiologists; Patients get preemptive education about the whole process from anesthesia to recovery stage within 15 minute by anesthesiologists.	Behavioral: preemptive education provided by anesthesiologists; A preemptive education about 4 stages (prepare, anethesia, surgery, and recovery) by anesthesiologists within 15 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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	The level(dermatome) of spinal anesthesia will be checked by pin-prick test by an anesthesiologist or nurse.	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)
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)	Nausea and vomiting will be assessed by questionnaire. (yes/no)	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)
Patient's satisfaction by questionnaire	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. )	From the end of surgery until 24 hours after surgery
Pain (assessed by NRS) until post-operative day 1	NRS (numeric rating scale) is detailed at Outcome number 3.	At 6, 12, 18, 24 hours after the end of surgery
Analgesic dosage (Morphile miligram equivalents) until post-operative day 1		From the end of surgery until 24 hours after surgery
Obstetric quality of recovery until post-operative day 1	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.	At 24 hours after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2408-040-1558

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No