Shivering_Basel_Baden

University Hospital Basel

Status: Enrolling

Conditions: Shivering

Treatments: Other: Gloves filled with warm tap water

Study type: Interventional

Funder types: Other

Identifiers

NCT04938219

2021-00866 qu20Buddeberg;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Shivering Treatment Group

Experimental group

Description:

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.

Treatment:

Other: Gloves filled with warm tap water

Control Group

No Intervention group

Description:

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