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Effect of Progressive Relaxation Exercises and TENS on Women Delivering Via Cesarean

Primary Purpose

Cesarean Section, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcutaneous electrical neural stimulation (TENS)
Progressive relaxation exercises (PRE)
Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)
Sponsored by
Derya Öztürk Özen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Section focused on measuring cesarean section, pain, breastfeeding, comfort, muscle relaxation, transcutaneous electrical neural stimulation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

TENS group

PRE group

TENS+PRE group

Control group

Arm Description

Transcutaneous electrical neural stimulation (TENS)

Progressive relaxation exercises (PRE)

Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in breastfeeding behavior
The LATCH Breastfeeding Diagnostic Tool (LATCH) was used in the evaluation of breastfeeding behavior.
Change in comfort level
The Postpartum Comfort Scale was used in the evaluation of comfort level.

Full Information

First Posted
August 17, 2022
Last Updated
August 19, 2022
Sponsor
Derya Öztürk Özen
Collaborators
Hacettepe University, Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05511571
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Derya Öztürk Özen
Collaborators
Hacettepe University, Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Acute Pain
Keywords
cesarean section, pain, breastfeeding, comfort, muscle relaxation, transcutaneous electrical neural stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS group
Arm Type
Experimental
Arm Description
Transcutaneous electrical neural stimulation (TENS)
Arm Title
PRE group
Arm Type
Experimental
Arm Description
Progressive relaxation exercises (PRE)
Arm Title
TENS+PRE group
Arm Type
Experimental
Arm Description
Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical neural stimulation (TENS)
Intervention Description
The TENS group: TENS application was implemented by the researchers in the patient room. The conventional TENS application took 30 minutes per session. The application continued until frequency reached 100 Hz, the pulse width reached 100 μs, and the current impedance reached a point where the women felt needling or tingling according to their tolerance. Before the application, the women were asked to lie in a supine position, and the area/skin where TENS would be applied was cleaned and dried. Two electrodes of TENS were placed 2 cm above the cesarean incision, and the other two electrodes 2 cm below the incision. The women were allowed to rest during the application, and they were accompanied by the researcher. A total of five TENS sessions, including two at four-hour intervals on the first day and three at eight-hour intervals on the second day, were held.
Intervention Type
Other
Intervention Name(s)
Progressive relaxation exercises (PRE)
Intervention Description
The PRE group: The PRE application was implemented in the patient room. A quiet and calm environment was prepared in the room for the intervention. The PRE application was implemented by the women under the researchers' instructions. Each session lasted 30 minutes. A total of five sessions, including two at four-hour intervals on the first day and three at eight-hour intervals on the second day, were held. The PRE application includes exercises based on stretching and then the relaxation of different muscle groups, accompanied by deep breathing. The exercises were carried out in the following way: First doing a deep breathing exercise and then stretching all the muscles from feet to face accompanied by breathing in, keeping the breath, and finally relaxing the muscles by breathing out at the same time.
Intervention Type
Other
Intervention Name(s)
Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)
Intervention Description
The TENS+PRE group: The PRE and TENS applications were carried out together in this group. The administration of the interventions was the same as in groups where only TENS and only PRE applications were carried out. In this group, first, a 30-minute PRE application was implemented, which was followed by a 30-minute-TENS application.
Primary Outcome Measure Information:
Title
Change in acute pain
Description
The Visual Analog Scale (VAS) was used in the evaluation of 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.
Secondary Outcome Measure Information:
Title
Change in breastfeeding behavior
Description
The LATCH Breastfeeding Diagnostic Tool (LATCH) was used in the evaluation of breastfeeding behavior.
Time Frame
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.
Title
Change in comfort level
Description
The Postpartum Comfort Scale was used in the evaluation of comfort level.
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Health Sciences
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Effect of Progressive Relaxation Exercises and TENS on Women Delivering Via Cesarean

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