Clinical trial NCT05511571: Effect of Progressive Relaxation Exercises and TENS on Women Delivering Via Cesarean
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Acute Pain
Keywords: cesarean section
pain
breastfeeding
comfort
muscle relaxation
transcutaneous electrical neural stimulation
Lead sponsor: Bozok University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Saglik Bilimleri Universitesi
First posted: 2022-08-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in acute pain
timeFrame: 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.
Secondary outcomes:
measure: Change in breastfeeding behavior
timeFrame: 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.
measure: Change in comfort level
timeFrame: 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.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences
Study officials:
References: