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

Not Applicable

Terminated

• Conditions: Cesarean Delivery; Shivering; Labor
• Interventions: Device: Sham bracelet; Device: Acupressure bracelet

• Registration Number: NCT03497507
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-01-11
• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Primary Completion: 2021-10-04
• Study Completion: 2021-10-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 43

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham bracelet	Sham bracelet	Patients randomized to sham group will wear bracelets on both hands which will not apply acupressure
Acupressure bracelet	Acupressure bracelet	Patients randomized to the experimental group will wear bracelets on both hands which will apply acupressure to the P6 acupoint.

Primary Outcome Measures

Name	Time	Method
Incidence of resolution of shivering at 15 minutes	up to 15 minutes	Incidence of resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section.

Secondary Outcome Measures

Name	Time	Method
Time to resolution of shivering	up to 15 minutes	Time to resolution of shivering
Degree of resolution of shivering	up to 15 minutes	Degree of patient-reported improvement in shivering as measured by Crossley \& Mahajan shivering scale: 0 = no shivering;1 = no visible muscle activity but piloerection, peripheral vasoconstriction, or both are present (other causes excluded); 2 = muscular activity in only one muscle group; 3 = moderate muscular activity in more than one muscle group but no generalized shaking; 4 = violent muscular activity that involves the whole body.
Degree of practitioner-reported improvement in shivering	up to 15 minutes	Degree of practitioner-reported improvement in shivering as measured by Crossley \& Mahajan shivering scale: 0 = no shivering;1 = no visible muscle activity but piloerection, peripheral vasoconstriction, or both are present (other causes excluded); 2 = muscular activity in only one muscle group; 3 = moderate muscular activity in more than one muscle group but no generalized shaking; 4 = violent muscular activity that involves the whole body.
Number of participants with skin irritation	up to 15 minutes	Number of participants with skin irritation at the site of acupressure obtained by patient self-reporting
Number of participants with pain	up to 15 minutes	Number of participants with pain at the site of acupressure obtained by patient self-reporting

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States