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

ConditionsShiveringSpinal Anesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorSeoul National University Hospital

About this 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 19 years or older

Gestational age 37 weeks or above

Elective surgey

Disqualifiers

Emergency surgery

Any sign of onset of labor

Difficulty with communication

Contraindications of spinal anesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • preemptive education provided by anesthesiologists

    Behavioral

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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Patients without preoperative education by anesthesiologistsNo intervention 0 interventions
Group B: Patients with preoperative education by anesthesiologistsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with intraoperative maternal shivering

Record when shivering occurred within the time frame

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

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).

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

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.
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

The level(dermatome) of spinal anesthesia will be checked by pin-prick test by an anesthesiologist or nurse.

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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