Clinical trial NCT03497507: Investigating the Effect of Acupressure on Shivering During a Cesarean Delivery in Women Who Were Previously Laboring With an Epidural
Official title: Effect of P6 Acupressure Stimulation on Shivering During Cesarean Section Under Epidural Anesthesia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shivering
Labor
Cesarean Delivery
Keywords: Shivering
Cesarean delivery
acupressure
P6 acupoint
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Once an obstetrician determines that a patient laboring with an epidural catheter should have a non-emergent cesarean section instead of continuing labor, the clinical anesthesiologist will contact the research team. A member of the research team will contact the patient while she is still in the labor and delivery room, at which time informed consent would be obtained.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of resolution of shivering at 15 minutes
timeFrame: up to 15 minutes
Secondary outcomes:
measure: Time to resolution of shivering
timeFrame: up to 15 minutes
measure: Degree of resolution of shivering
timeFrame: up to 15 minutes
measure: Degree of practitioner-reported improvement in shivering
timeFrame: up to 15 minutes
measure: Number of participants with skin irritation
timeFrame: up to 15 minutes
measure: Number of participants with pain
timeFrame: up to 15 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jeffery Zahn, MD
role: PRINCIPAL_INVESTIGATOR
References: