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

NCT03497507 | Terminated DMC

• 1 other identifier: GCO 17-2495
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Shivering; Labor; Cesarean Delivery

Keywords

Shivering; Cesarean delivery; acupressure; P6 acupoint

Outcome Measures

Primary Outcomes (1)

• Incidence of resolution of shivering at 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 Outcomes (5)

• Time to resolution of shivering

  up to 15 minutes

• Degree of resolution of shivering

  up to 15 minutes

• Degree of practitioner-reported improvement in shivering

  up to 15 minutes

• Number of participants with skin irritation

  up to 15 minutes

• Number of participants with pain

  up to 15 minutes

Study Arms (2)

Sham bracelet

PLACEBO COMPARATOR

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

Device: Sham bracelet

Acupressure bracelet

EXPERIMENTAL

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

Device: Acupressure bracelet

Interventions

Sham bracelet DEVICE

Patients will wear bracelets on both hands

Sham bracelet

Acupressure bracelet DEVICE

Patients will wear bracelets on both hands.

Acupressure bracelet

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: This study is studying shivering during a cesarean delivery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Jeffery Zahn, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: January 11, 2018
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

US (1)