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

NCT05991921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-08-16

No results posted yet for this study

Summary

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).

Conditions

  • Postoperative Recovery
  • Wound Healing
  • Postpartum Comfort
  • Postpartum Pain

Interventions

OTHER

Transcutaneous Electrical Nerve Stimulation (TENS)

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. Two pairs of TENS electrodes were placed on the upper and lower border of the cesarean section incision line. A total of 4 electrodes were used in a sterile package for each participant. TENS stimulation was applied at a frequency of 100 Hz and was increased starting from 0 mA. The participant's stimulation was fixed at the mA level, where he felt optimal but did not feel discomfort. The pretest data were applied to the participants who met the inclusion criteria and volunteered to participate in the study, by the researcher 2 in the patient rooms 10 hours after the cesarean section. Post-test data were obtained by the same investigator 16 hours after cesarean section.

OTHER

Plasebo-Fake TENS

Participants in the placebo group 10-12 postpartum. at hours and 14-16. Two pairs of TENS electrodes were placed at the same time as the intervention group. TENS electrodes were attached to the participants in this group for 30 minutes, the device was operated but no electric current was applied.

Sponsors & Collaborators

  • Inonu University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2023-06-26
Completion
2023-08-05

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05991921 on ClinicalTrials.gov