Menopausal and Postmenopausal WomenNCT07158320
Relaxation Training for Menopausal and Postmenopausal Women
A study testing Relaxation training in people with Menopausal and Postmenopausal Women, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Relaxation training is one of the methods used in the reduction of many menopausal symptoms such as vasomotor symptoms, sleep disturbance, and emotional status changes. Symptoms seen during menopause; sleep disturbance and lack of body awareness negatively affect women's daily lives. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal and Postmenopausal Women
- What is being tested?
- Relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2021to 19 Dec 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between 50-65 years old,
- Going through menopause period naturally
- People who do not receive hormone therapy
Who cannot join
- Who entered menopause surgically or medically,
- With a history of cancer,
- Who take hormone therapy,
- With neurological disease,
- Who use anti-symptom medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relaxation Training for Vasomotor Symptoms and Body Awareness in Menopausal and Postmenopausal Women
Relaxation training is one of the methods used in the reduction of many menopausal symptoms such as vasomotor symptoms, sleep disturbance, and emotional status changes.
Symptoms seen during menopause; sleep disturbance and lack of body awareness negatively affect women's daily lives. Relaxation exercises play an important role for women to manage this process better. In previous studies, the effects of relaxation training on hot flashes have been investigated, but a comprehensive study including body awareness and sleep problems has not been conducted yet. The aim of this study is to investigate the effect of relaxation training on vasomotor symptoms and body awareness in menopausal and postmenopausal periods.
- Conditions
- Menopausal and Postmenopausal Women
- Being tested
- Relaxation training
- Keywords
- Menopause, Women's Health, Relaxation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation trainingBehavioural
In Jacobson's progressive muscle relaxation method, the first step is to make various muscle groups contract, to realize what it feels like to contract in this body area; The second step is to release these contracted muscle groups and notice how a relaxed muscle feels as the contraction subsides. During the exercise, the contraction is continued for 5 seconds. After the contraction, the muscles are relaxed for 10-15 seconds and in the meantime, rest is provided. Before starting the training, the person is taught the correct breathing technique and is asked to use the correct breathing technique throughout the practice. The practice should be done calmly without haste. During the practice, people should choose clothes that they can feel comfortable in. The practice should be applied in a quiet, dim environment where people can feel comfortable. It can also be performed with the eyes closed.
| Study group | Role | What they receive |
|---|---|---|
| Menopausal period group | Experimental | 24 individuals in the menopausal period Receives: Behavioral: Relaxation training |
| Postmenopausal period group | Experimental | 24 individuals in the postmenopausal period (patients who have been without a menstrual period for 12 months) Receives: Behavioral: Relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal symptoms evaluation scale (MSRS)
MSRS was developed by Schneider et al (2000) to measure the severity of general menopausal symptoms. The scale consists of 11 items in total and each item is scored between 0 and 4. Scoring was graded as 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score on the scale is 44, and the lowest score is 0. The increase in the scale score indicates the increase in the severity of the complaint.
Measured: 6 weeks
Pittsburhg sleep quality scale (PSQS)
PSQS is an index that evaluates sleep problems and sleep quality in the last month, consisting of a total of 7 sub-components and 18 problems. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6) and daytime dysfunction (component 7). Each component is evaluated with a minimum of 0 and a maximum of 3 points. The scale total score is 0 at the lowest and 21 at the highest. According to the scale scoring, a score of 5 and above indicates that sleep quality is low.
Measured: 6 weeks
Body awareness questionnaire
The body awareness questionnaire is a questionnaire consisting of four subgroups (changes in body process, sleep-wake cycle, estimation at the onset of the disease, estimation of body responses) aiming to determine the normal or abnormal sensitivity level of body composition. It includes 18 questions that measure various aspects of body consciousness, such as the ability to recognize physical sensations, engagement with the body, and awareness of physical condition in different circumstances. Each item is evaluated with a minimum of 1 and a maximum of 7 points. A high score indicates a high level of body awareness.
Measured: 6 weeks
Body perception scale
Body perception scale is a scale that determines the satisfaction of the person with 40 different body parts or functions. The scale consists of 40 items and each item is scored between 1 and 5 (1 = I like it very much, 2 = I like it a lot, 3 = I am undecided, 4 = I do not like it very much; 5 = I do not like it at all). The total scale score is between 40 and 200. A high scale score indicates a decrease in satisfaction, and a low score indicates an increase in satisfaction.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start16 Jun 2021
- Primary completion19 Nov 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopausal and Postmenopausal WomenStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Ozunlu Pekyavas, Baskent University
- Investigators
- Nihan Ozunlu Pekyavas, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158320
- Sponsor's protocol ID
- KA 21/293
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sahin G, Pekyavas NO, Aytar A. Relaxation training for vasomotor symptoms and body awareness in menopausal and postmenopausal women. J Bodyw Mov Ther. 2025 Dec;45:502-507. doi: 10.1016/j.jbmt.2025.09.021. Epub 2025 Sep 19.
PubMed 41316612
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation Training for Vasomotor Symptoms and Body Awareness in Menopausal and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07158320
- Acronym / sponsor ID
- KA 21/293
- Conditions
- Menopausal and Postmenopausal Women
- Keywords
- Menopause, Women's Health, Relaxation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 5 Sep 2025 (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.
Relaxation training is one of the methods used in the reduction of many menopausal symptoms such as vasomotor symptoms, sleep disturbance, and emotional status changes.
Symptoms seen during menopause; sleep disturbance and lack of body awareness negatively affect women's daily lives. Relaxation exercises play an important role for women to manage this process better. In previous studies, the effects of relaxation training on hot flashes have been investigated, but a comprehensive study including body awareness and sleep problems has not been conducted yet. The aim of this study is to investigate the effect of relaxation training on vasomotor symptoms and body awareness in menopausal and postmenopausal periods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menopausal period group | Experimental | Behavioral: Relaxation training24 individuals in the menopausal period |
| Postmenopausal period group | Experimental | Behavioral: Relaxation training24 individuals in the postmenopausal period (patients who have been without a menstrual period for 12 months) |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between 50-65 years old,
- Going through menopause period naturally
- People who do not receive hormone therapy
Key exclusion criteria (5 listed)
- Who entered menopause surgically or medically,
- With a history of cancer,
- Who take hormone therapy,
- With neurological disease,
- Who use anti-symptom medication.
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 |
|---|---|---|
| Relaxation trainingIn Jacobson's progressive muscle relaxation method, the first step is to make various muscle groups contract, to realize what it feels like to contract in this body area; The second step is to release these contracted muscle groups and notice how a relaxed muscle feels as the contraction subsides. During the exercise, the contraction is continued for 5 seconds. After the contraction, the muscles are relaxed for 10-15 seconds and in the meantime, rest is provided. Before starting the training, the person is taught the correct breathing technique and is asked to use the correct breathing technique throughout the practice. The practice should be done calmly without haste. During the practice, people should choose clothes that they can feel comfortable in. The practice should be applied in a quiet, dim environment where people can feel comfortable. It can also be performed with the eyes closed. | Behavioural | Menopausal period group, Postmenopausal period group |
Primary outcome
Menopausal symptoms evaluation scale (MSRS)
Time frame: 6 weeks
MSRS was developed by Schneider et al (2000) to measure the severity of general menopausal symptoms. The scale consists of 11 items in total and each item is scored between 0 and 4. Scoring was graded as 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score on the scale is 44, and the lowest score is 0. The increase in the scale score indicates the increase in the severity of the complaint.
Pittsburhg sleep quality scale (PSQS)
Time frame: 6 weeks
PSQS is an index that evaluates sleep problems and sleep quality in the last month, consisting of a total of 7 sub-components and 18 problems. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6) and daytime dysfunction (component 7). Each component is evaluated with a minimum of 0 and a maximum of 3 points. The scale total score is 0 at the lowest and 21 at the highest. According to the scale scoring, a score of 5 and above indicates that sleep quality is low.
Body awareness questionnaire
Time frame: 6 weeks
The body awareness questionnaire is a questionnaire consisting of four subgroups (changes in body process, sleep-wake cycle, estimation at the onset of the disease, estimation of body responses) aiming to determine the normal or abnormal sensitivity level of body composition. It includes 18 questions that measure various aspects of body consciousness, such as the ability to recognize physical sensations, engagement with the body, and awareness of physical condition in different circumstances. Each item is evaluated with a minimum of 1 and a maximum of 7 points. A high score indicates a high level of body awareness.
Body perception scale
Time frame: 6 weeks
Body perception scale is a scale that determines the satisfaction of the person with 40 different body parts or functions. The scale consists of 40 items and each item is scored between 1 and 5 (1 = I like it very much, 2 = I like it a lot, 3 = I am undecided, 4 = I do not like it very much; 5 = I do not like it at all). The total scale score is between 40 and 200. A high scale score indicates a decrease in satisfaction, and a low score indicates an increase in satisfaction.
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 5 Sep 2025.
- Derived from this study: PubMed 41316612Sahin G, Pekyavas NO, Aytar A. Relaxation training for vasomotor symptoms and body awareness in menopausal and postmenopausal women. J Bodyw Mov Ther. 2025 Dec;45:502-507. doi: 10.1016/j.jbmt.2025.09.021. Epub 2025 Sep 19.
- 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.
Nihan Ozunlu Pekyavas principal investigator
Baskent 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 Relaxation training in people with Menopausal and Postmenopausal Women, run by Baskent 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 3 inclusion and 5 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 5 Sep 2025. 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?
Menopausal symptoms evaluation scale (MSRS) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07158320, which also lists 1 linked publication.
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 5 Sep 2025.