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Recruiting NCT06708169

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

No phase Interventional Shivering Spinal Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: preemptive education provided by anesthesiologists.
Who it may be relevant to
Registry conditions: Shivering, Spinal Anesthesia. Basic parameters: from 19 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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?

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (11)
  • 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.]
  • 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.]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • Patient's satisfaction by questionnaire [Time frame: From the end of surgery until 24 hours after surgery]
  • Pain (assessed by NRS) until post-operative day 1 [Time frame: At 6, 12, 18, 24 hours after the end of surgery]
  • Analgesic dosage (Morphile miligram equivalents) until post-operative day 1 [Time frame: From the end of surgery until 24 hours after surgery]
  • Obstetric quality of recovery until post-operative day 1 [Time frame: At 24 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06708169 · 2408-040-1558

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗