Shivering_Basel_Baden

Shivering Clinical Trial

Official title:

Treatment of Intraoperative Shivering During Caesarean Section With Gloves Filled With Warm Water: a Multicentric, Randomised, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938219
• Other study ID #: 2021-00866; qu20Buddeberg
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2021
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Bigna Buddeberg, MD
• Phone: +41 61 328 6417
• Email: bigna.buddeberg[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Shivering is an involuntary, repetitive activity of skeletal muscles that often, but not exclusively, occurs as a thermoregulatory response to cold. It is associated with neuraxial anaesthesia and is therefore a commonly observed phenomenon during caesarean sections. The main cause for this is a sympathetic block of vasoconstriction in the legs, leading to cutaneous heat loss and lower core temperature. This is not always accompanied by a cold sensation, because the perceived skin temperature is increased. Out of all common side effects of neuraxial anaesthesia, shivering is perceived as the most uncomfortable and disruptive one. It can also interfere with monitoring of blood pressure, oxygen saturation and legibility of electrocardiograms. It increases the metabolic rate and oxygen consumption by up to 400%. Therefore, lactic acid and carbon dioxide production are significantly increased. Pregnant women have reduced cardiac and pulmonary reserves and may therefore have less capacity to adapt to the increased metabolic demands caused by shivering.

The incidence of shivering during caesarean section at the University Hospital Basel was determined by a previous study to be 41.0%. Studies have been conducted about pharmacological treatment options for intraoperative shivering during caesarean section. However, pharmacological treatment in pregnant and breastfeeding women is best reduced to a minimum.

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. The warm water method has been used by doctors to reduce shivering, but the actual effects of it have never been scientifically proven. The gloves will be used as a treatment, not a prophylactic measure. Therefore, only the women who exhibit shivering during surgery will be treated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Shivering

Intervention

Other:
• Gloves filled with warm tap water
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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden AG, Department of Anaesthesiology	Baden	Aargau
Switzerland	University Hospital Basel; Department of Anaesthesiology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; - No visible muscle activity, but one or more of piloerection, peripheral vasoconstriction or peripheral cyanosis (other causes excluded).; - Muscular activity in only one muscle group.; - Moderate muscular activity in more than one muscle group, but not generalized shaking.; - 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	Change in subjective comfort levels of the patients before and after the intervention on a 11-point scale	Change in subjective comfort level of the participant before and after the intervention on a 11-point scale (0 being very uncomfortable; 10 being very comfortable). The patient will be asked to rate their comfort level every time a shivering score is obtained.	at baseline, at 2 and 5 minutes after the first assessment, and in the post-anaesthesia recovery room (approx.1 hour)

External Links

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