Effects of Progressive Relaxation Exercises and Planned Training After Cesarean Section on Pain, Anxiety and Comfort

February 13, 2026 updated by: Sukran Ertekin Pinar, Cumhuriyet University
Effects of Progressive Relaxation Exercises and Planned Training after Cesarean Section on Pain, Anxiety and Comfort

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.

Detailed Description

The study consisted of a total of 129 women who underwent cesarean section (progressive relaxation exercise group: 43, planned training group: 43, control group: 43). Data were collected using a Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale. Intergroup comparisons revealed statistically significant differences (p˂0.05) in the mean scores of the Visual Analog Scale, State Anxiety Inventory, Trait Anxiety Inventory, and Postpartum Comfort Scale in the post-test after exercise and training for women in the exercise, training, and control groups. After progressive relaxation exercise and training, pain levels decreased in women in the exercise and training groups, anxiety levels decreased in women in the training group, and comfort levels increased in women in both the exercise and training groups.

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.
129

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

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • on the first postoperative day,
  • at least four hours after analgesic administration,
  • mobilized,
  • with their baby present,
  • their baby without any health problems,
  • without any physical or mental illness,
  • without communication problems,
  • who volunteered to participate were included in the study.

Exclusion Criteria:

  • women who were not present on the first postoperative day,
  • had not received analgesic treatment for at least four hours,
  • were not mobile,
  • did not have their baby with them,
  • their baby had any health problems,
  • they had a physical or mental illness,
  • they had difficulty communicating,
  • they did not volunteer to participate were excluded from the study.

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: Progressive Relaxation Exercises after Cesarean Section
Progressive relaxation exercises began with breathing exercises, continued with muscle relaxation exercises, and lasted 30 minutes. Before starting the exercise, the environment was made quiet and free from external disturbances. The patient was also seated comfortably, and standard meditation music was played during the exercise. Progressive relaxation exercises combine the contraction and relaxation of large muscle groups such as the face, arms, legs, neck, and back with deep breathing. The exercises were performed by taking a deep breath, tensing the muscles, maintaining this tension for 5-7 seconds, and then relaxing the muscles (15-20 seconds). Throughout the exercise, the individual was instructed to continue breathing slowly and deeply through the nose and exhaling through the mouth.
Behavioral: Progressive Relaxation Exercise group
On the first postoperative day, the women were met with, informed, and their written consent was obtained. Women in the Progressive Relaxation Exercise group who met the inclusion criteria were administered the Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale via face-to-face interviews on the first postoperative day. Completing all forms took 15-20 minutes. Relaxation exercises began with breathing exercises, continued with muscle relaxation exercises, and lasted 30 minutes. In the final test phase, the Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale were repeated on the second postoperative day.
Experimental: Planned Training after Cesarean Section
The training group received pre-planned training based on the literature. The training content included topics such as postpartum uterine changes, bleeding and vaginal discharge, elimination, sleep and rest, postpartum blues, medication use, initiation of sexual intercourse, timing of the resumption of menstruation, contraceptive methods, nutrition, breast care and breast problems, infant care, breastfeeding, and infant vaccinations. During the training, educational materials such as illustrated guides on family planning were used, and an educational brochure prepared by the researcher based on the literature was also given to the women after the training. The training was conducted face-to-face with each woman by the researcher, in accordance with adult education principles, and lasted 30-45 minutes. In addition, training methods such as lecturing, question-and-answer, discussion, brainstorming, and problem-solving were used during the training.
Behavioral: Planned Education group
On the first postoperative day, the women were met with, informed, and their written consent was obtained. Women in the Planned Education group who met the inclusion criteria were administered the Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale via face-to-face interviews on the first day. Completing all forms took 15-20 minutes. The training was conducted face-to-face by the researcher for each woman, in accordance with adult education principles, and lasted 30-45 minutes.
No Intervention: Standard of care Group
The control group received no treatment. They only received standard hospital care procedures along with the Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale (pre-test, post-test).

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
Visual Analog Scale
Time Frame: baseline
The scale is graded as 0-10 cm long, with 0=no pain, 10=the most severe pain. It is applied by the individual marking a point corresponding to the level of pain they feel. The distance between the determined point and the lowest part of the line is evaluated in centimeters. The value found indicates the patient's pain level.
baseline
Postpartum Comfort Scale
Time Frame: Baseline
The Postpartum Comfort Scale assesses the physical, psychospiritual, and sociocultural comfort of women who have had both cesarean and vaginal deliveries. Physical and bodily perceptions constitute the physical comfort subscale. Spiritual and psychological components form the psychospiritual comfort subscale. Interpersonal, family, and social relationships, as well as components related to finances and support systems, constitute the sociocultural comfort subscale. The scale, which uses a five-point Likert scale, consists of 34 items. The lowest possible score is 34, and the highest is 170. Values close to 170 indicate a high level of comfort.
Baseline
State-Trait Anxiety Inventory
Time Frame: Baseline
The State Anxiety Inventory consists of 20 items and requires individuals to describe how they feel at a specific moment under specific circumstances, taking into account their feelings about the situation. The Trait Anxiety Inventory also consists of 20 items and requires individuals to describe how they feel in a given situation, regardless of the circumstances. High scores on both the State and Trait Anxiety Inventories indicate high anxiety levels, while low scores indicate low anxiety levels.The scale allows for scores ranging from a minimum of 20 to a maximum of 80.
Baseline

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
Visual Analog Scale
Time Frame: On the second postoperative day after a cesarean section
The scale is graded as 0-10 cm long, with 0=no pain, 10=the most severe pain. It is applied by the individual marking a point corresponding to the level of pain they feel. The distance between the determined point and the lowest part of the line is evaluated in centimeters. The value found indicates the patient's pain level.
On the second postoperative day after a cesarean section
Postpartum Comfort Scale
Time Frame: On the second postoperative day after a cesarean section
The Postpartum Comfort Scale assesses the physical, psychospiritual, and sociocultural comfort of women who have had both cesarean and vaginal deliveries. Physical and bodily perceptions constitute the physical comfort subscale. Spiritual and psychological components form the psychospiritual comfort subscale. Interpersonal, family, and social relationships, as well as components related to finances and support systems, constitute the sociocultural comfort subscale. The scale, which uses a five-point Likert scale, consists of 34 items. The lowest possible score is 34, and the highest is 170. Values close to 170 indicate a high level of comfort.
On the second postoperative day after a cesarean section
State-Trait Anxiety Inventory
Time Frame: On the second postoperative day after a cesarean section
The State Anxiety Inventory consists of 20 items and requires individuals to describe how they feel at a specific moment under specific circumstances, taking into account their feelings about the situation. The Trait Anxiety Inventory also consists of 20 items and requires individuals to describe how they feel in a given situation, regardless of the circumstances. High scores on both the State and Trait Anxiety Inventories indicate high anxiety levels, while low scores indicate low anxiety levels.The scale allows for scores ranging from a minimum of 20 to a maximum of 80.
On the second postoperative day after a cesarean section

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.
Cumhuriyet University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sukran Ertekin Pinar, Prof. Dr., Cumhuriyet University

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.
January 1, 2023

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.
December 30, 2023

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.
December 30, 2023

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).
January 27, 2026

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.
January 27, 2026

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.
February 3, 2026

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.
February 17, 2026

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.
February 13, 2026

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.
January 1, 2023

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.
  • TR SİVAS 07
  • SFF-2022-096 (Other Grant/Funding Number: Sivas Cumhuriyet University Scientific Research Projects)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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