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

August 19, 2022 updated by: Derya Öztürk Özen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TENS group
Transcutaneous electrical neural stimulation (TENS)
Device: Transcutaneous electrical neural stimulation (TENS)
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.
Experimental: PRE group
Progressive relaxation exercises (PRE)
Other: Progressive relaxation exercises (PRE)
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.
Experimental: TENS+PRE group
Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)
Other: Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)
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.
No Intervention: Control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in 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.
The LATCH Breastfeeding Diagnostic Tool (LATCH) was used in the evaluation of 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
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.
The Postpartum Comfort Scale was used in the evaluation of 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Derya Öztürk Özen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hacettepe University
Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA-17142

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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