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

NCT ID: NCT04917614

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-18

Study Completion Date

2022-01-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transcutaneous Electrical Acupoint Stimulation

Intervention Type DEVICE

Transcutaneous Electrical Acupoint Stimulation

Control Group

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

Group Type SHAM_COMPARATOR

Transcutaneous Electrical Acupoint Stimulation

Intervention Type DEVICE

Transcutaneous Electrical Acupoint Stimulation

Interventions

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Transcutaneous Electrical Acupoint Stimulation

Transcutaneous Electrical Acupoint Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Betul Kozanhan

Ass.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Betul Kozanhan

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TEAS and ObsQoR-10

Identifier Type: -

Identifier Source: org_study_id

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