Postmenopausal PeriodNCT05483413
The Effect of Progressive Relaxation Exercises on Sleep Quality and Fatigue in Postmenopausal Period
A study testing progressive relaxation exercises in people with Postmenopausal Period and Fatigue, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Period, Fatigue, Sleep Quality
- What is being tested?
- progressive relaxation exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Science University
Kütahya, 43000
About this study
Official title: 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.
Read the 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
- Being tested
- progressive relaxation exercises
- Keywords
- postmenopausal period, fatigue, sleep quality, progressive relaxation exercise
- Medical subject headings
- Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exercisesBehavioural
Progressive relaxation exercises are a cognitive behavioral technique that provides relaxation in the muscles that individuals can do alone.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Relaxation Exercises | Experimental | Progressive relaxation exercises will be applied to this group for 8 weeks. Receives: Behavioral: progressive relaxation exercises |
| Standard of Care | No intervention | This group will continue their routine coping habits against sleep and fatigue problems in the postmenopausal period for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatugue
At the end of 8 weeks of progressive relaxation exercises, change in fatigue
Measured: 8-week process.
Change in sleep quality
At the end of 8 weeks of progressive relaxation exercises, change in sleep quality
Measured: 8-week process.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start15 Feb 2022
- Primary completion15 Jun 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal PeriodStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elif Tuğçe ÇİTİL, PhD, Study director, Kütahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483413
- Sponsor's protocol ID
- E-41997688-050.99-34916
- Status last verified
- Jun 2022
- First submitted
- 19 Jul 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kütahya Health Science University
- ClinicalTrials.gov ID
- NCT05483413
- Acronym / sponsor ID
- E-41997688-050.99-34916
- Conditions
- Postmenopausal Period, Fatigue, Sleep Quality
- Keywords
- postmenopausal period, fatigue, sleep quality, progressive relaxation exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Progressive Relaxation Exercises | Experimental | Behavioral: progressive relaxation exercisesProgressive relaxation exercises will be applied to this group for 8 weeks. |
| Standard of Care | No intervention | –This group will continue their routine coping habits against sleep and fatigue problems in the postmenopausal period for 8 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive relaxation exercisesProgressive relaxation exercises are a cognitive behavioral technique that provides relaxation in the muscles that individuals can do alone. | Behavioural | Progressive Relaxation Exercises |
Primary outcome
Change in fatugue
Time frame: 8-week process.
At the end of 8 weeks of progressive relaxation exercises, change in fatigue
Change in sleep quality
Time frame: 8-week process.
At the end of 8 weeks of progressive relaxation exercises, change in sleep quality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Tuğçe ÇİTİL, PhD study director
Kütahya Health Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive relaxation exercises in people with Postmenopausal Period and Fatigue, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatugue (time frame: 8-week process.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.