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

NCT ID: NCT05483413

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2022-09-15

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.

Conditions

Postmenopausal Period; Fatigue; Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Progressive Relaxation Exercises

Progressive relaxation exercises will be applied to this group for 8 weeks.

Group Type: EXPERIMENTAL

progressive relaxation exercises

Intervention Type: BEHAVIORAL

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

Standard of Care

This group will continue their routine coping habits against sleep and fatigue problems in the postmenopausal period for 8 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

progressive relaxation exercises

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kutahya Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elif Tuğçe ÇİTİL, PhD

Role: STUDY_DIRECTOR

Kütahya Health Science University

Locations

Kütahya Health Science University

Kütahya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-41997688-050.99-34916

Identifier Type: -

Identifier Source: org_study_id