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

Kütahya Health Science University

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Sleep Quality; Postmenopausal Period
• Intervention / Treatment: Behavioral: progressive relaxation exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kütahya, Turkey, 43000
    • Kutahya Health Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progressive Relaxation Exercises; Progressive relaxation exercises will be applied to this group for 8 weeks.	Behavioral: progressive relaxation exercises; Progressive relaxation exercises are a cognitive behavioral technique that provides relaxation in the muscles that individuals can do alone.
No Intervention: Standard of Care; 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?

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.

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Study Director: Elif Tuğçe ÇİTİL, PhD, Kutahya Health Science University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: fatigue; sleep quality; postmenopausal period; progressive relaxation exercise
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: E-41997688-050.99-34916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No