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Completed

NCT Number: NCT05483413

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

progressive relaxation exercises

Behavioral

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

Primary outcomes

  1. Change in fatugue

    Time frame: 8-week process.

    At the end of 8 weeks of progressive relaxation exercises, change in fatigue

  2. Change in sleep quality

    Time frame: 8-week process.

    At the end of 8 weeks of progressive relaxation exercises, change in sleep quality

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Kütahya Health Science University

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2022
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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