Shivering_Basel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-24

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Women undergoing caesarean section under neuraxial anaesthesia will be randomised into either the treatment group or control group (2 arms).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Shivering Treatment Group

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.

Group Type EXPERIMENTAL

Gloves filled with warm tap water

Intervention Type OTHER

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

Control Group

Participants in the control group will only be observed, and not given additional treatment for the shivering.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes