Shivering, Spinal Anesthesia
Conditions
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?
Interventions
BEHAVIORALpreemptive education provided by anesthesiologists
A preemptive education about 4 stages (prepare, anethesia, surgery, and recovery) by anesthesiologists within 15 minute.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with intraoperative maternal shivering | 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative pain (Numeric rating scale, NRS). | 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 |
| 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 | 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. |
| 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) | — |
| 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. | — |
| Patient's satisfaction by questionnaire | 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. ) |
| Pain (assessed by NRS) until post-operative day 1 | At 6, 12, 18, 24 hours after the end of surgery | NRS (numeric rating scale) is detailed at Outcome number 3. |
| 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 | 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. |
| Post-operative nausea and vomiting in recovery room (by questionnaire) | 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) |
Countries
South Korea
Contacts
Primary ContactJang
Outcome results
None listed