The Effect of Progressive Relaxation Exercises on Sleep Quality and Fatigue in Postmenopausal Period

Study Overview
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Brief Summary
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The population of the study will be postmenopausal women who applied to the KETEM unit of a hospital in western Turkey for examination. This study is a two-group randomized controlled study.

Detailed Description
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The population of the study will be postmenopausal women who applied to the KETEM Unit of a hospital in western Turkey for examination. This study is a two-group randomized controlled study. These groups will be the experimental group to which Progressive Relaxation Exercises (PGE) will be applied and the control group who will continue their routine habits regarding sleep and fatigue problems in the postmenopausal period. Minimum number of women to be assigned to groups in the study; determined by power analysis. To our knowledge, a sample size of 90 participants was selected and alpha=0.05 was selected to achieve 80% power to detect the traditionally moderate W=0.30 (moderate effect) differences between study groups, as we know of, according to the literature review. 1988; Foul et al, 2007). As a result, it was found that 60 women in total, 30 women in the experimental group and 30 women in the control group, should be included in the study. However, considering the risks such as women leaving the job over time and not being able to reach women, 3 women for each group (10% of the sample) will be included in the study as substitutes and it is anticipated that the research will be completed with a total of 66 women. In order to provide an equal number of samples in the experimental and control groups and to ensure that both groups are similar in terms of all factors, except for the PGE application whose effectiveness will be examined, those who experience high levels of fatigue (high scores on the Piper Fatigue Scale) and low sleep quality (Pittsburg Sleep Quality Index) Randomization will be made between those who score 5 or more on the scales) and those who are similar in terms of independent variables. Randomizer.org program will be used to determine the women in the experimental and control groups, by choosing the random randomization method in order to provide an equal number of samples in both groups. At the end of the randomization, difference analyzes will be made between the women who will be assigned to the experimental and control groups in terms of sociodemographic, menopausal and PGE-related characteristics.

Official Title
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Kütahya Health Science University

Conditions
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Fatigue, Postmenopausal Period, Sleep Quality

Intervention / Treatment
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* Behavioral: progressive relaxation exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being in the postmenopausal period, Agreeing to participate in the research, Being able to read and write, Those experiencing high levels of fatigue Women with poor sleep quality Exclusion Criteria: Experiencing menopause due to surgery, pharmacological reasons, Not being willing to participate in the study, Presence of any communication problems, Being in premenopause and perimenopause period.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive Relaxation Exercises<br>Progressive relaxation exercises will be applied to this group for 8 weeks. | Behavioral: progressive relaxation exercises<br>* Progressive relaxation exercises are a cognitive behavioral technique that provides relaxation in the muscles that individuals can do alone.<br>|
| No Intervention: Standard of Care<br>This group will continue their routine coping habits against sleep and fatigue problems in the postmenopausal period for 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatugue | At the end of 8 weeks of progressive relaxation exercises, change in fatigue | 8-week process. | 
| Change in sleep quality | At the end of 8 weeks of progressive relaxation exercises, change in sleep quality | 8-week process. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopausal period, fatigue, sleep quality, progressive relaxation exercise