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Accupressure of P6 to Reduce Nausea During Cesarean Section

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04799587
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
60.1
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Magnet at P6
  • Other: Magnet applied to arm not at P6 pressure point.
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two group, sham vs actual location of pressure point.Two group, sham vs actual location of pressure point.
Masking:
Single (Participant)
Masking Description:
Participant will not know whether the pressure point is correct or sham location.
Primary Purpose:
Treatment
Official Title:
The Use of P6 Acupressure for the Reduction of Intraoperative and Postoperative Nausea and Vomiting in Women Undergoing Cesarean Delivery: a Randomized Trial
Actual Study Start Date :
May 26, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
May 30, 2026

Arms and Interventions

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.

Other: Magnet at P6
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).

Other: Magnet applied to arm not at P6 pressure point.
Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.

Outcome Measures

Primary Outcome Measures

  1. Presence of emesis during scheduled cesarean delivery [Delivery of baby]

    Presence of emesis during the scheduled cesarean delivery

Secondary Outcome Measures

  1. Presence of nausea during scheduled cesarean delivery [Delivery of baby]

    The presence of nausea during the scheduled cesarean delivery.

  2. presence of nausea after scheduled cesarean delivery [48 hours after delivery of baby]

    The presence of nausea after scheduled cesarean delivery

  3. Maternal satisfaction of the IONV/PONV management using a VAS [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.

  4. Number of antiemetic rescue medications given during the intraoperative period [End of surgery]

    Total number of additional antiemetic rescue medications given during the intraoperative period.

  5. Number of additional antiemetic rescue medications given postoperatively [48 hours after surgery]

    Total number of number of additional antiemetic rescue medications given during the post operative period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern Memorial Hospital Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Feyce Peralta, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Feyce M. Peralta, MD, MS, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT04799587
Other Study ID Numbers:
  • STU#: 00213854
First Posted:
Mar 16, 2021
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Feyce M. Peralta, MD, MS, Principal Investigator, Northwestern University
Accupressure
Cesarean Delivery
Nausea
Vomiting
Additional relevant MeSH terms:
Nausea
Vomiting

Study Results

No Results Posted as of Jan 12, 2022