- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384637
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
129
Phase
- 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
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-
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Sivas, Turkey (Türkiye)
- Sivas Cumhuriyet University
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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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.
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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.
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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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: baseline
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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.
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baseline
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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.
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Baseline
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State-Trait Anxiety Inventory
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
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.
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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.
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On the second postoperative day after a cesarean section
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State-Trait Anxiety Inventory
Time Frame: On the second postoperative day after a cesarean section
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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.
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On the second postoperative day after a cesarean section
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
January 1, 2023
Primary Completion (Actual)
December 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
January 27, 2026
First Submitted That Met QC Criteria
January 27, 2026
First Posted (Actual)
February 3, 2026
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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