The Effect of Progressive Relaxation Exercises on Sleep Quality and Fatigue in Postmenopausal Period
Primary Purpose
Postmenopausal Period, Fatigue, Sleep Quality
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
progressive relaxation exercises
Sponsored by
About this trial
This is an interventional supportive care trial for Postmenopausal Period focused on measuring postmenopausal period, fatigue, sleep quality, progressive relaxation exercise
Eligibility Criteria
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.
Sites / Locations
- Kütahya Health Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Progressive Relaxation Exercises
Standard of Care
Arm Description
Progressive relaxation exercises will be applied to this group for 8 weeks.
This group will continue their routine coping habits against sleep and fatigue problems in the postmenopausal period for 8 weeks.
Outcomes
Primary Outcome Measures
Change in fatugue
At the end of 8 weeks of progressive relaxation exercises, change in fatigue
Change in sleep quality
At the end of 8 weeks of progressive relaxation exercises, change in sleep quality
Secondary Outcome Measures
Full Information
NCT ID
NCT05483413
First Posted
July 19, 2022
Last Updated
February 14, 2023
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT05483413
Brief Title
The Effect of Progressive Relaxation Exercises on Sleep Quality and Fatigue in Postmenopausal Period
Official Title
Kütahya Health Science University
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kutahya Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Period, Fatigue, Sleep Quality
Keywords
postmenopausal period, fatigue, sleep quality, progressive relaxation exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Progressive Relaxation Exercises
Arm Type
Experimental
Arm Description
Progressive relaxation exercises will be applied to this group for 8 weeks.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
This group will continue their routine coping habits against sleep and fatigue problems in the postmenopausal period for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
progressive relaxation exercises
Intervention Description
Progressive relaxation exercises are a cognitive behavioral technique that provides relaxation in the muscles that individuals can do alone.
Primary Outcome Measure Information:
Title
Change in fatugue
Description
At the end of 8 weeks of progressive relaxation exercises, change in fatigue
Time Frame
8-week process.
Title
Change in sleep quality
Description
At the end of 8 weeks of progressive relaxation exercises, change in sleep quality
Time Frame
8-week process.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Tuğçe ÇİTİL, PhD
Organizational Affiliation
Kütahya Health Science University
Official's Role
Study Director
Facility Information:
Facility Name
Kütahya Health Science University
City
Kütahya
ZIP/Postal Code
43000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Progressive Relaxation Exercises on Sleep Quality and Fatigue in Postmenopausal Period
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