Clinical trial NCT06708169: Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery
Official title: Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shivering
Spinal Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 130
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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?


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

Primary outcomes:
measure: Number of participants with intraoperative maternal shivering
timeFrame: 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:
measure: Intraoperative body temperature
timeFrame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after entering the operating room until the end of surgery.
measure: Intraoperative pain (Numeric rating scale, NRS).
timeFrame: 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.
measure: Spinal anesthesia level (dermatome)
timeFrame: 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)
measure: Post-operative spinal anesthesia level in recovery room
timeFrame: 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)
measure: Number of Participants with Post-operative shivering in recovery room
timeFrame: 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)
measure: Post-operative body temperature in recovery room
timeFrame: 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)
measure: Post-operative nausea and vomiting in recovery room (by questionnaire)
timeFrame: 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)
measure: Patient's satisfaction by questionnaire
timeFrame: From the end of surgery until 24 hours after surgery
measure: Pain (assessed by NRS) until post-operative day 1
timeFrame: At 6, 12, 18, 24 hours after the end of surgery
measure: Analgesic dosage (Morphile miligram equivalents) until post-operative day 1
timeFrame: From the end of surgery until 24 hours after surgery
measure: Obstetric quality of recovery until post-operative day 1
timeFrame: At 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References: