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

Kütahya Health Science University

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05483413
Enrollment
63
Registered
2022-08-02
Start date
2022-02-15
Completion date
2022-09-15
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Postmenopausal Period, Sleep Quality

Keywords

postmenopausal period, fatigue, sleep quality, progressive relaxation exercise

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.

Interventions

BEHAVIORALprogressive relaxation exercises

Progressive relaxation exercises are a cognitive behavioral technique that provides relaxation in the muscles that individuals can do alone.

Sponsors

Kutahya Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

randomized controlled

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in fatugue8-week process.At the end of 8 weeks of progressive relaxation exercises, change in fatigue
Change in sleep quality8-week process.At the end of 8 weeks of progressive relaxation exercises, change in sleep quality

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026