NCT04917614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 18, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

June 2, 2021

Last Update Submit

September 23, 2024

Conditions

Recovery

Keywords

ObsQoR-10Trecoverycesereanpostoperative

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery

    Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool

    The first 24 hours postoperatively

Study Arms (2)

group teas

ACTIVE COMPARATOR

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

Control Group

SHAM COMPARATOR

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

Device: Transcutaneous Electrical Acupoint Stimulation

Interventions

Transcutaneous Electrical Acupoint StimulationDEVICE

Transcutaneous Electrical Acupoint Stimulation

Control Groupgroup teas

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Elective cesarean operation
  • Able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

July 18, 2021

Primary Completion

January 24, 2022

Study Completion

January 24, 2022

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)