- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07412093
The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
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Sivas, Merkez, Turkey (Türkiye), 00058
- Sivas Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 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.
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Progressive relaxation exercises begin with breathing exercises and continue with muscle stretching and relaxation exercises, lasting an average of 30 minutes.
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|
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.
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The training group will receive pre-planned training in accordance with the literature, delivered as group training in line with adult learning principles.
|
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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.
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What is the study measuring?
Primary Outcome Measures
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.
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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.
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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.
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Beginning
|
Secondary Outcome Measures
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.
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sukran Ertekin Pinar, Cumhuriyet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TR SİVAS 08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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