ShiveringNCT06708169
Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery
A study testing preemptive education provided by anesthesiologists in people with Shivering and Spinal Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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? Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Shivering, Spinal Anesthesia
- What is being tested?
- preemptive education provided by anesthesiologists
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Dec 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years or older
- Gestational age 37 weeks or above
- Elective surgey
Who cannot join
- Emergency surgery
- Any sign of onset of labor
- Difficulty with communication
- Contraindications of spinal anesthesia
- Pre-eclampsia
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Hansol Kim, MD, +82220722467, hansolfrkr@gmail.com
About this study
Official title: Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery: a Randomized Controlled 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?
- Conditions
- Shivering, Spinal Anesthesia
- Being tested
- preemptive education provided by anesthesiologists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preemptive education provided by anesthesiologistsBehavioural
A preemptive education about 4 stages (prepare, anethesia, surgery, and recovery) by anesthesiologists within 15 minute.
| Study group | Role | What they receive |
|---|---|---|
| Patients without preoperative education by anesthesiologists | No intervention | Patients get minimal information about the surgical process and their questions will be answered by obstetrician. |
| Patients with preoperative education by anesthesiologists | Experimental | Patients get preemptive education about the whole process from anesthesia to recovery stage within 15 minute by anesthesiologists. Receives: Behavioral: preemptive education provided by anesthesiologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with intraoperative maternal shivering
Record when shivering occurred within the time frame
Measured: 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 (11)
Intraoperative body temperature
Measured: 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).
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
Measured: 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)
Measured: 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
The level(dermatome) of spinal anesthesia will be checked by pin-prick test by an anesthesiologist or nurse.
Measured: 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
Measured: 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
Measured: 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)
Nausea and vomiting will be assessed by questionnaire. (yes/no)
Measured: 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
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. )
Measured: From the end of surgery until 24 hours after surgery
Pain (assessed by NRS) until post-operative day 1
NRS (numeric rating scale) is detailed at Outcome number 3.
Measured: At 6, 12, 18, 24 hours after the end of surgery
Analgesic dosage (Morphile miligram equivalents) until post-operative day 1
Measured: From the end of surgery until 24 hours after surgery
Obstetric quality of recovery until post-operative day 1
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.
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start9 Dec 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708169
- Sponsor's protocol ID
- 2408-040-1558
- Status last verified
- Sep 2024
- First submitted
- 31 Oct 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06708169
- Acronym / sponsor ID
- 2408-040-1558
- Conditions
- Shivering, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without preoperative education by anesthesiologists | No intervention | –Patients get minimal information about the surgical process and their questions will be answered by obstetrician. |
| Patients with preoperative education by anesthesiologists | Experimental | Behavioral: preemptive education provided by anesthesiologistsPatients get preemptive education about the whole process from anesthesia to recovery stage within 15 minute by anesthesiologists. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 19 years or older
- Gestational age 37 weeks or above
- Elective surgey
Key exclusion criteria (5 listed)
- Emergency surgery
- Any sign of onset of labor
- Difficulty with communication
- Contraindications of spinal anesthesia
- Pre-eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preemptive education provided by anesthesiologistsA preemptive education about 4 stages (prepare, anethesia, surgery, and recovery) by anesthesiologists within 15 minute. | Behavioural | Patients with preoperative education by anesthesiologists |
Primary outcome
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
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Related trials for Shivering
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
Not yet recruiting
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, Inadvertent Perioperative Hypothermia
Recruiting
Effect Of Acupressure On Hypothermıa And Shıverıng After Cesarean Sectıon
Hypothermia, Shivering
Not yet recruitingPhase 4
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preemptive education provided by anesthesiologists in people with Shivering and Spinal Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jang (821025640576, wwdzhl55@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.