Shivering_Basel_Baden
Treatment of Intraoperative Shivering During Caesarean Section With Gloves Filled With Warm Water: a Multicentric, Randomised, Controlled Trial
1 other identifier
interventional
200
1 country
2
Brief Summary
Shivering is known to occur in around 40% of women as a side effect of neuraxial anaesthesia during caesarean section.Women undergoing caesarean section under neuraxial anaesthesia are randomised into either the treatment group or control group. Women in both groups are observed during caesarean section. This study is to test a non-pharmacological and non-invasive treatment with two groups, an intervention and a control group. In the intervention group, intraoperative shivering during caesarean section is treated by placing two surgical gloves filled with warm water into the women's hands. In the control group, women will be treated with the current standard of care, which does not include specific treatment of shivering.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedStudy Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 22, 2024
April 1, 2024
4.4 years
June 16, 2021
April 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in intensity of shivering measured on a 5-point scale
Shivering is evaluated during caesarean section 5 minutes after intervention. Shivering is graded on a scale from 0 (No shivering) to 4 (Violent muscular activity that involves the entire upper body) .The score will be recorded before the intervention and at 2 and 5 minutes after initiation of the intervention, as well as after arrival at the recovery area. Score: 0 - No shivering. 1. \- No visible muscle activity, but one or more of piloerection, peripheral vasoconstriction or peripheral cyanosis (other causes excluded). 2. \- Muscular activity in only one muscle group. 3. \- Moderate muscular activity in more than one muscle group, but not generalized shaking. 4. \- Violent muscular activity that involves the entire upper body.
at baseline, at 2 and 5 minutes after the first assessment, and in the post-anaesthesia recovery room (approx.1 hour)ent.
Secondary Outcomes (1)
Change in subjective comfort levels of the patients before and after the intervention on a 11-point scale
at baseline, at 2 and 5 minutes after the first assessment, and in the post-anaesthesia recovery room (approx.1 hour)
Study Arms (2)
Shivering Treatment Group
EXPERIMENTALParticipants will be observed, and intervention will begin when a shivering score of 2 or higher is reached. The participants in the treatment group will receive one glove filled with warm water into each hand.
Control Group
NO INTERVENTIONParticipants in the control group will only be observed, and not given additional treatment for the shivering.
Interventions
The intervention in the treatment group will consist of nonsterile gloves, filled with regular tap water at a comfortable warm temperature and sealed with a plastic clip. The temperature of the water will not be measured, the investigators will take a temperature that feels comfortable in their hands
Eligibility Criteria
You may qualify if:
- Ability to give informed consent
- Age older than 18 years and younger than 40 years.
- Gestational age \>36 weeks
- Shivering during regional anaesthesia for caesarean section
You may not qualify if:
- Inability to give informed consent
- Latex allergy
- Receiving combined spinal epidural anaesthesia (CSEA)
- Secondary spinal anaesthesia for caesarean section in patients with unsatisfactory epidural labour analgesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kantonsspital Baden AG, Department of Anaesthesiology
Baden, Canton of Aargau, 5404, Switzerland
University Hospital Basel; Department of Anaesthesiology
Basel, 4031, Switzerland
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Bigna Buddeberg, MD
University Hospital, Basel, Switzerland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2021
First Posted
June 24, 2021
Study Start
June 24, 2021
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
April 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
Trial and participant data will be handled with uttermost discretion and is only accessible to authorised personnel who require the data to fulfil their duties within the scope of the study. On the eCRFs and other study specific documents, participants are only identified by a unique participant number. Trial and participant data will be handled with uttermost discretion and is only accessible to authorised personnel who require the data to fulfil their duties within the scope of the study. On the eCRFs and other study specific documents, participants are only identified by a unique participant number. The participant identification list will be stored in a locked place by the sponsor-investigator. Password access to the eCRFs will only be given to the investigators directly enrolled in recruitment of participants and capturing of data.