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NCT05991921

The Effect of TENS Applied in the Early Postpartum Period on Incision Healing, Pain and Comfort

Completed NA Last updated 16 August 2023
What this trial tests

NA trial testing Transcutaneous Electrical Nerve Stimulation (TENS) in Postoperative Recovery in 138 participants. Completed in 5 August 2023.

Timeline
26 January 2023
Primary endpoint
26 June 2023
5 August 2023

Quick facts

Lead sponsorInonu University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposesupportive care
Enrollment138
Start date26 January 2023
Primary completion26 June 2023
Estimated completion5 August 2023
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Inonu University

Who can join

18 and older, female only, with Postoperative Recovery or Wound Healing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: In this study, it was aimed to determine the effect of TENS applied in the early postpartum period after cesarean section on incision healing, pain and comfort. Methods: This study was designed as randomized, single-blind, placebo-controlled. All participants signed an informed consent statement before starting the study. The study sample of 138 (TENS group n=46, placebo group n=46, control group n=46). TENS application, postpartum 10-12. at hours and 14-16. It was applied twice for 30 minutes each. Researcher 1 programmed the TENS unit and was the only researcher who knew whether TENS was active or in placebo mode. The pretest data were applied to the participants who met the inclusion criteria and volunteered to participate in the study, in the patient rooms 10 hours after the cesarean section. Post-test data were obtained by the same investigator 16 hours after cesarean section. Data were obtained with Personal Information Form, Postoperative Recovery Index (PoRI), REEDA Scale, Visual Analogue Scale (VAS), and Postpartum Comfort Scale (PPCQ).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Effects of Transcutaneous Electrical Nerve Stimulation Applied in the Early Postpartum Period After Cesarean Birth on Healing, Pain, and Comfort.
    Sabancı Baransel E, Barut S, Uçar T. · · 2024 · cited 3× · PMID 38470299 · DOI 10.1111/jmwh.13625

Verify or expand the search:

Other trials of Transcutaneous Electrical Nerve Stimulation (TENS)

Trials testing the same drug.

Other recruiting trials for Postoperative Recovery

Currently open trials in the same condition.

Other Inonu University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05991921.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing