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

Fatigue Clinical Trial

Official title:

Kütahya Health Science University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483413
• Other study ID #: E-41997688-050.99-34916
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: June 2022
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Postmenopausal Period
• Sleep Quality

Intervention

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

Locations

Country	Name	City	State
Turkey	Kütahya Health Science University	Kütahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fatugue	At the end of 8 weeks of progressive relaxation exercises, change in fatigue	8-week process.
Primary	Change in sleep quality	At the end of 8 weeks of progressive relaxation exercises, change in sleep quality	8-week process.