Accupressure of P6 to Reduce Nausea During Cesarean Section

February 28, 2024 updated by: Feyce M. Peralta, MD, MS, Northwestern University

The Use of P6 Acupressure for the Reduction of Intraoperative and Postoperative Nausea and Vomiting in Women Undergoing Cesarean Delivery: a Randomized Trial

The purpose of this study is to evaluate if the addition of P6 pressure point stimulation as opposed to sham-point stimulation will decrease intraoperative and postoperative nausea and vomiting (IONV and PONV) for patients undergoing non-emergent cesarean delivery. We hypothesize that the addition of stimulation of the P6 pressure point to our institutional current standard of care (phenylephrine infusion, intravenous fluid bolus, and as needed intraoperative ondansetron) will decrease the occurrence of intraoperative emesis.

Study Overview

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years of age
  • English-speaking
  • Pregnant patients presenting for scheduled cesarean delivery of a full-term fetus (>37 weeks' gestation)
  • Patients scheduled as ERAC
  • Parturients undergoing spinal anesthesia

Exclusion Criteria:

  • Patients requiring emergent delivery,
  • Fetal demise
  • Patients with adhesive allergy/sensitivity
  • Patients with allergy/sensitivity to nickel,
  • Patients with inability to consent,
  • Patients with known abnormal placentation
  • Patients with pacemakers/defibrillators
  • Patients with positive COVID-19 tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: P6 Accupressure Group
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
Sham Comparator: Sham Pressure Point
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of emesis during scheduled cesarean delivery
Time Frame: Delivery of baby
Presence of emesis during the scheduled cesarean delivery
Delivery of baby

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of nausea during scheduled cesarean delivery
Time Frame: Delivery of baby
The presence of nausea during the scheduled cesarean delivery.
Delivery of baby
presence of nausea after scheduled cesarean delivery
Time Frame: 48 hours after delivery of baby
The presence of nausea after scheduled cesarean delivery
48 hours after delivery of baby
Maternal satisfaction of the IONV/PONV management using a VAS
Time Frame: 48 hours after delivery of baby

Maternal satisfaction with IONV/PONV medical management using a sliding VAS (visual analog scale) of 0 representing poor satisfaction and 10 representing greatest level of satisfaction.

The maternal satisfaction with intraoperative and postoperative nausea and vomiting management.

48 hours after delivery of baby
Number of antiemetic rescue medications given during the intraoperative period
Time Frame: End of surgery
Total number of additional antiemetic rescue medications given during the intraoperative period.
End of surgery
Number of additional antiemetic rescue medications given postoperatively
Time Frame: 48 hours after surgery
Total number of number of additional antiemetic rescue medications given during the post operative period.
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Feyce Peralta, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU#: 00213854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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