Warm water gloves to reduce shivering during caesarean sections
Treatment of Intraoperative Shivering During Caesarean Section With Gloves Filled With Warm Water: a Multicentric, Randomised, Controlled Trial
This study tests if using warm water gloves can help reduce shivering in women having a caesarean section with spinal anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 2 sites (Baden, Aargau and 1 other locations) |
| Trial ID | NCT04938219 on ClinicalTrials.gov |
What this trial studies
This study investigates a non-pharmacological approach to manage intraoperative shivering in women undergoing caesarean sections with neuraxial anaesthesia. Participants are randomly assigned to either an intervention group, where warm water-filled gloves are applied to their hands, or a control group receiving standard care without specific treatment for shivering. The study aims to assess the effectiveness of this method in reducing shivering, which can complicate monitoring and increase metabolic demands during surgery. The research is conducted at the University Hospital Basel and Kantonsspital Baden AG.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 years, with a gestational age greater than 36 weeks, who experience shivering during neuraxial anaesthesia for caesarean sections.
Not a fit: Patients with latex allergies or those receiving combined spinal epidural anaesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a simple and effective way to alleviate shivering during caesarean sections, improving patient comfort and surgical conditions.
How similar studies have performed: Previous studies have explored pharmacological treatments for shivering, but this non-invasive approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Baden, Aargau and 1 other locations
- Kantonsspital Baden AG, Department of Anaesthesiology — Baden, Aargau, Switzerland (Recruiting)
- University Hospital Basel; Department of Anaesthesiology — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Bigna Buddeberg, MD — University Hospital, Basel, Switzerland
- Study coordinator: Bigna Buddeberg, MD
- Email: bigna.buddeberg@usb.ch
- Phone: +41 61 328 6417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.