Investigating the Effect of Acupressure on Shivering During a Cesarean Delivery in Women Who Were Previously Laboring With an Epidural

Mount Sinai Health System

Status: Terminated

Conditions: Labor; Cesarean Delivery; Shivering

Treatments: Device: Sham bracelet; Device: Acupressure bracelet

Study type: Interventional

Funder types: Other

Identifiers

NCT03497507

GCO 17-2495

Details and patient eligibility

About

Shivering during a cesarean section can be quite uncomfortable for the patient as well as make it difficult for the anesthesiologist to obtain vital signs. The researchers will investigate whether or not applying pressure to the P6 acupressure point during a cesarean section can treat shivering. The hypothesis is that shivering will be alleviated with acupressure.

Full description

The purpose of this study is to determine whether applying pressure to the left and right P6 acupoints can treat shivering in a patient undergoing a cesarean section. The hypothesis is that bilateral stimulation of P6 with pressure can stop or alleviate shivering.

The primary endpoint is resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section.

The secondary endpoints include:

1. Time to resolution of shivering
2. Degree of patient-reported improvement in shivering
3. Degree of practitioner-reported improvement in shivering
4. Assessment of skin irritation and/or pain at the site of acupressure vs control

Patient information will be stored in a locked cabinet on labor and delivery, and that cabinet will be located in a T3-locked office. The link between subject ID and patient ID will be stored in a different office on labor and delivery, also under a T3 lock.

Patients who are laboring with an epidural catheter and subsequently require a cesarean section will be selected. This patient population has a MUCH higher rate of shivering during the cesarean section as compared to patients who undergo elective scheduled cesarean sections under spinal anesthesia. By selecting this group, the investigators are not only increasing chances of identifying shivering but also decreasing variability between patient characteristics by limiting it to one type (only epidural and not spinal) and limiting the number of screen failures.

Enrollment: 43 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• a patient has to be classified as an American Society of Anesthesiology (ASA) physical status I, II, or III, laboring with an epidural catheter, and subsequently taken for a non-emergent cesarean section under epidural anesthesia with a core body temperature range of 35.5-38.0 degrees Celsius during shivering.

Exclusion criteria

• ASA status 4 or higher
• core body temperature lower than 35.5 or higher than 38.0
• thyroid disease
• systemic infection
• emergent cesarean section,
• a psychiatric, cognitive or medical condition that would compromise adherence to the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

Sham bracelet

Placebo Comparator group

Description:

Patients randomized to sham group will wear bracelets on both hands which will not apply acupressure

Treatment:

Device: Sham bracelet

Acupressure bracelet

Experimental group

Description:

Patients randomized to the experimental group will wear bracelets on both hands which will apply acupressure to the P6 acupoint.

Treatment:

Device: Acupressure bracelet