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Clinical Trials/NCT05511571
NCT05511571
Completed
Not Applicable

The Effect of Progressive Relaxation Exercises and Transcutaneous Electrical Nerve Stimulation Administered to Women Delivering Via Cesarean Section on Acute Pain, Breastfeeding Behaviors, and Comfort Levels: A Randomized Controlled Study

Derya Öztürk Özen1 site in 1 country120 target enrollmentAugust 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section
Sponsor
Derya Öztürk Özen
Enrollment
120
Locations
1
Primary Endpoint
Change in acute pain
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study aimed to determine the effect of progressive relaxation exercises and transcutaneous electrical nerve stimulation administered to women delivering via cesarean section on acute pain, breastfeeding behavior, and comfort levels. Single-Blind, Randomized Controlled Study. This study was carried out in the obstetrics and gynecology clinic of a university hospital affiliated with the Ministry of Health in Turkey between August 20, 2018 and April 15, 2019. A total of 120 participants were randomly assigned to one of four groups, which included a transcutaneous electrical neural stimulation (TENS) group, a progressive relaxation exercises (PRE) group, a combined intervention (TENS+PRE) group, and a control group. Data were collected with a data collection form, the visual analogue scale (VAS), the LATCH breastfeeding diagnostic tool (LATCH), and the postpartum comfort scale (PCS). In the analysis of the data, numbers, percentages, and chi-square tests were used. Also, median values, Wilcoxon Signed-rank test, and Kruskal-Wallis H test were employed for continuous variables.

Registry
clinicaltrials.gov
Start Date
August 20, 2018
End Date
April 15, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Derya Öztürk Özen
Responsible Party
Sponsor Investigator
Principal Investigator

Derya Öztürk Özen

Principal Investigator

Bozok University

Eligibility Criteria

Inclusion Criteria

  • women who were aged between 18 and 45,
  • who were in the postoperative 8th hour,
  • who had a transverse cesarean section,
  • who, as well as their babies, did not develop any complications during pregnancy, delivery, and the postpartum period.

Exclusion Criteria

  • women who did not have an open wound on their body and/or allergic disease on their skin,
  • who had cardiac arrhythmia or a pacemaker,
  • who had a risk of epilepsy,
  • who had epilepsy, eclampsia, kidney or liver disease,
  • who had previously applied TENS and PRE methods,
  • who were morbidly obese (with a BMI value of over 40),
  • who used chronic opioids, antidepressants, and psychoactive drugs.

Outcomes

Primary Outcomes

Change in acute pain

Time Frame: VAS was applied in the first eighth hour during the postoperative 48 hours, before and after each application in the intervention groups, and in the control group at the times corresponding to the applications in the intervention groups.

The Visual Analog Scale (VAS) was used in the evaluation of acute pain.

Secondary Outcomes

  • Change in breastfeeding behavior(LATCH was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.)
  • Change in comfort level(Postpartum Comfort Scale was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.)

Study Sites (1)

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