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

NCT ID: NCT03497507

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2021-10-04

Brief Summary

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.

Detailed 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.

Conditions

Shivering; Labor; Cesarean Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham bracelet

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

Group Type: PLACEBO_COMPARATOR

Sham bracelet

Intervention Type: DEVICE

Patients will wear bracelets on both hands

Acupressure bracelet

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

Group Type: EXPERIMENTAL

Acupressure bracelet

Intervention Type: DEVICE

Patients will wear bracelets on both hands.

Interventions

Sham bracelet

Patients will wear bracelets on both hands

Intervention Type: DEVICE

Acupressure bracelet

Patients will wear bracelets on both hands.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Daniel Katz

Anesthesiologist, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffery Zahn, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 17-2495

Identifier Type: -

Identifier Source: org_study_id