Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06708169

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

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?

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Shivering Spinal Anesthesia

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location status: Recruiting

Location contact

Hansol Kim, MD

CONTACT

[email protected]

+82220722467

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preemptive education provided by anesthesiologists

Behavioral

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

Primary outcomes

  1. Number of participants with intraoperative maternal shivering

    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.

    Record when shivering occurred within the time frame

Secondary outcomes

  1. Intraoperative body temperature

    Time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after entering the operating room until the end of surgery.

  2. Intraoperative pain (Numeric rating scale, NRS).

    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.

    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

  3. Spinal anesthesia level (dermatome)

    Time frame: 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)

  4. Post-operative spinal anesthesia level in recovery room

    Time frame: 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.

  5. Number of Participants with Post-operative shivering in recovery room

    Time frame: 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)

  6. Post-operative body temperature in recovery room

    Time frame: 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)

  7. Post-operative nausea and vomiting in recovery room (by questionnaire)

    Time frame: 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)

  8. Patient's satisfaction by questionnaire

    Time frame: 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. )

  9. Pain (assessed by NRS) until post-operative day 1

    Time frame: At 6, 12, 18, 24 hours after the end of surgery

    NRS (numeric rating scale) is detailed at Outcome number 3.

  10. Analgesic dosage (Morphile miligram equivalents) until post-operative day 1

    Time frame: From the end of surgery until 24 hours after surgery

  11. Obstetric quality of recovery until post-operative day 1

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jang

CONTACT

[email protected]

821025640576

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.