- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03497507
Investigating the Effect of Acupressure on Shivering During a Cesarean Delivery in Women Who Were Previously Laboring With an Epidural
Effect of P6 Acupressure Stimulation on Shivering During Cesarean Section Under Epidural Anesthesia.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Time to resolution of shivering
- Degree of patient-reported improvement in shivering
- Degree of practitioner-reported improvement in shivering
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Sham bracelet
Patients randomized to sham group will wear bracelets on both hands which will not apply acupressure
|
Patients will wear bracelets on both hands
|
EXPERIMENTAL: Acupressure bracelet
Patients randomized to the experimental group will wear bracelets on both hands which will apply acupressure to the P6 acupoint.
|
Patients will wear bracelets on both hands.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of resolution of shivering at 15 minutes
Time Frame: up to 15 minutes
|
Incidence of resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section.
|
up to 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to resolution of shivering
Time Frame: up to 15 minutes
|
Time to resolution of shivering
|
up to 15 minutes
|
Degree of resolution of shivering
Time Frame: 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.
|
up to 15 minutes
|
Degree of practitioner-reported improvement in shivering
Time Frame: 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.
|
up to 15 minutes
|
Number of participants with skin irritation
Time Frame: up to 15 minutes
|
Number of participants with skin irritation at the site of acupressure obtained by patient self-reporting
|
up to 15 minutes
|
Number of participants with pain
Time Frame: up to 15 minutes
|
Number of participants with pain at the site of acupressure obtained by patient self-reporting
|
up to 15 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeffery Zahn, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GCO 17-2495
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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