The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women

February 13, 2026 updated by: Sukran Ertekin Pinar, Cumhuriyet University
The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 will be conducted with women who are in the menopausal period. Data will be collected using the Personal Information Form, Menopause Symptoms Assessment Scale, Perceived Stress Scale and Beck Anxiety Scale.

Study; It will be divided into three groups: progressive relaxation exercise group, planned training group and control group. A total of 144 participants, 48 for each group, were planned to be included in the sample.

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.
144

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 (Türkiye)
    • Merkez
      • Sivas, Merkez, Turkey (Türkiye), 00058
        • Sivas Cumhuriyet University

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Not having communication and perception problems
  • Being in menopause
  • Not having a mental illness diagnosis
  • Voluntary participation in the study

Exclusion Criteria:

  • Having communication and perception problems
  • Not being in menopause
  • Not having a mental illness diagnosis
  • Not being a volunteer to participate in 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 exercise
Progressive relaxation exercises combine deep breathing with the contraction and relaxation of muscle groups such as the hands, arms, upper arms, feet, lower legs and calves, hips, abdomen and lower back, chest, face, shoulders and back, neck, jaw, lips, eyes, and forehead. After taking a deep breath, the muscles are tensed, this tension is maintained for 5-10 seconds, and then the muscles are relaxed (10-20 seconds). When a muscle is tense, the deeper the tension, the deeper the relaxation will be when it is released. During the exercise, the individual is asked to continue breathing in slowly and deeply through the nose and exhaling through the mouth.
Behavioral: Progressive relaxation
Progressive relaxation exercises begin with breathing exercises and continue with muscle stretching and relaxation exercises, lasting an average of 30 minutes.
Experimental: planned education
The topics covered in the educational content include: What menopause is, causes of menopause, factors affecting the onset of menopause, complaints during menopause, general symptoms of menopause, nutrition during menopause, sleep during menopause, emotional problems during menopause, and coping strategies.
Other: Planned education
The training group will receive pre-planned training in accordance with the literature, delivered as group training in line with adult learning principles.
No Intervention: control group
The control group will not receive any intervention; only the Perceived Stress Scale, Menopause Symptom Assessment Scale, and Beck Anxiety Scale will be administered as pre-tests and post-tests.

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
Perceived Stress Scale
Time Frame: Beginning
The scale consists of 10 items and is evaluated based on a total score. The scale is scored on a scale of 1-5. The total score ranges from 10 to 50, and an increase in the score indicates an increase in perceived stress level. The scale is assessed before any training or relaxation exercises during the initial encounter with women.
Beginning
Beck Anxiety Scale
Time Frame: Beginning
The scale ranges from a minimum of 0 to a maximum of 63 points. However, based on the scores obtained on the scale, patients' anxiety levels are classified as follows: 0-7 points is low, 8-15 points is mild, 16-25 points is moderate, and 26-63 points is high anxiety. A high score indicates that the individual is experiencing a high level of anxiety.The scale is assessed before any training or relaxation exercises during the initial encounter with women.
Beginning
Menopause Symptom Assessment Scale
Time Frame: Beginning
The scale consists of 11 items and 3 subscales. An increase in the total score obtained from the scale indicates an increase in the severity of complaints and, consequently, a negative impact on quality of life. The lowest possible score on the entire scale is 0, and the highest is 44.The scale is assessed before any training or relaxation exercises during the initial encounter with women.
Beginning

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
Perceived Stress Scale
Time Frame: One month after relaxation exercises and planned training practices
The scale consists of 10 items and is evaluated based on a total score. The scale is scored on a scale of 1-5. The total score ranges from 10 to 50, and an increase in the score indicates an increase in perceived stress level. The scale is administered to the women again one month after the planned training and relaxation exercises are implemented.
One month after relaxation exercises and planned training practices
Beck Anxiety Scale
Time Frame: One month after relaxation exercises and planned training practices
Description: The scale ranges from a minimum of 0 to a maximum of 63 points. However, based on the scores obtained on the scale, patients' anxiety levels are classified as follows: 0-7 points is low, 8-15 points is mild, 16-25 points is moderate, and 26-63 points is high anxiety. A high score indicates that the individual is experiencing a high level of anxiety.The scale is administered to the women again one month after the planned training and relaxation exercises are implemented.
One month after relaxation exercises and planned training practices
Menopause Symptom Assessment Scale
Time Frame: One month after relaxation exercises and planned training practices
Description: The scale consists of 11 items and 3 subscales. An increase in the total score obtained from the scale indicates an increase in the severity of complaints and, consequently, a negative impact on quality of life. The lowest possible score on the entire scale is 0, and the highest is 44.The scale is administered to the women again one month after the planned training and relaxation exercises are implemented.
One month after relaxation exercises and planned training practices

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, 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.
February 1, 2026

Primary Completion (Estimated)

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.
June 30, 2026

Study Completion (Estimated)

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.
June 30, 2026

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 29, 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.
February 13, 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 17, 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, 2026

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 08

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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