Shivering_Basel_Baden

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Shivering

Intervention / Treatment
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* Other: Gloves filled with warm tap water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women undergoing caesarean section under neuraxial anaesthesia will be randomised into either the treatment group or control group (2 arms).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shivering Treatment Group<br>Participants 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. | Other: Gloves filled with warm tap water<br>* 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<br>|
| No Intervention: Control Group<br>Participants in the control group will only be observed, and not given additional treatment for the shivering. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative shivering, caesarean section, neuraxial anaesthesia