Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section

Sponsor

Konya Meram State Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04917614

Collaborator

(none)

Enrollment

Location

Arms

6.2

Actual Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this prospective and randomized trial is to investigate the effect of TEAS on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in patients undergoing elective cesarean section.

Condition or Disease	Intervention/Treatment	Phase
Recovery	Device: Transcutaneous Electrical Acupoint Stimulation	N/A

Detailed Description

Acupoint stimulation is postulated to modulate neurological signal transmission through afferent nociceptive pathways. Acupoint stimulation has been associated with positive effects on perioperative symptoms such as nausea, pain, and sleep disturbance. Transcutaneous electrical acupuncture point stimulation (TEAS) is an acupuncture treatment developed by combining traditional Chinese acupuncture with transcutaneous electrical nerve stimulation. TEAS has proven to be effective in postoperative pain and nausea-vomiting by applying a current of different frequencies, intensities, and waveforms through electrodes adhering to the skin. Using TEAS may relieve perioperative symptoms without increasing the risk of drug-related adverse events and alleviate and improve the patient's health condition, including the postoperative perspective.

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section

Actual Study Start Date :

Jul 18, 2021

Actual Primary Completion Date :

Jan 24, 2022

Actual Study Completion Date :

Jan 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group teas Patients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at Hegu (LI4), Neiguan (PC6), and Zusanli (St 36) with an electronic acupuncture device.	Device: Transcutaneous Electrical Acupoint Stimulation Transcutaneous Electrical Acupoint Stimulation
Sham Comparator: Control Group In the sham group, the patients were connected to the electronic acupuncture, but electronic stimulation was not applied.	Device: Transcutaneous Electrical Acupoint Stimulation Transcutaneous Electrical Acupoint Stimulation

Arm

Intervention/Treatment

Active Comparator: group teas

Patients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at Hegu (LI4), Neiguan (PC6), and Zusanli (St 36) with an electronic acupuncture device.

Device: Transcutaneous Electrical Acupoint Stimulation

Transcutaneous Electrical Acupoint Stimulation

Sham Comparator: Control Group

In the sham group, the patients were connected to the electronic acupuncture, but electronic stimulation was not applied.

Device: Transcutaneous Electrical Acupoint Stimulation

Transcutaneous Electrical Acupoint Stimulation

Outcome Measures

Primary Outcome Measures

Quality of Recovery [The first 24 hours postoperatively]
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 48 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Elective cesarean operation
Able to give informed consent

Exclusion Criteria:

Patients with neurological or psychological diseases
patients with chronic analgesic and antidepressant drug use
Patients unable to communicate
Patients previously treated with TEAS or acupuncture,
Patients with heart failure and have pace-maker,
patient with local infection in the TEAS area

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Betul Kozanhan	Konya		Turkey	42005

Sponsors and Collaborators

Konya Meram State Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Betul Kozanhan, Ass.Prof., Konya Meram State Hospital

ClinicalTrials.gov Identifier:

NCT04917614

Other Study ID Numbers:

TEAS and ObsQoR-10

First Posted:

Jun 8, 2021

Last Update Posted:

Jan 25, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Betul Kozanhan, Ass.Prof., Konya Meram State Hospital

Study Results

No Results Posted as of Jan 25, 2022