Clinical trial NCT05483413: The Effect of Progressive Relaxation Exercises on Sleep Quality and Fatigue in Postmenopausal Period
Official title: Kütahya Health Science University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Period
Fatigue
Sleep Quality
Keywords: postmenopausal period
fatigue
sleep quality
progressive relaxation exercise
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 63
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in fatugue
timeFrame: 8-week process.
measure: Change in sleep quality
timeFrame: 8-week process.
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Health Science University
Study officials:
affiliation: Kütahya Health Science University
name: Elif Tuğçe ÇİTİL, PhD
role: STUDY_DIRECTOR
References: