MenopauseNCT04695808
The Effect of Yoga Training on Menopausal Symptoms on Menopausal Women
A study testing yoga in people with Menopause, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the adoption of yoga practice without health risks by women and its implementation… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Sep 2020to 29 Nov 2020
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to participate in research,
- Can read and write in Turkish,
- Open to communication,
- Those who are between the ages of 40-60 and do not experience menstruation for at least one year, Do not use medication to treat menopausal symptoms,
- No diagnosed musculoskeletal disease, no severe heart disease,
- Not doing regular exercise and yoga,
- Not surgically menopausal,
- Women without psychiatric problems
Who cannot join
- Refusing to participate in research,
- Can't read and write Turkish,
- Communication is not possible,
- Those who are younger than 40 or older than 60 have experienced menstruation for at least one year
- Using medication for the treatment of menopausal symptoms,
- Those with a diagnosed musculoskeletal disease, severe heart disease,
- Doing regular exercise and yoga,
- Surgically menopausal, Women with psychiatric problems
Trial locations and contacts
1 site in 1 country.
About this study
Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the adoption of yoga practice without health risks by women and its implementation as a lifestyle may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it is aimed to determine the effect of yoga training on menopausal symptoms. The research will be carried out with menopausal women between the ages of 40-60 in Famagusta region. Women will be divided into two groups as intervention and control. Personal information form and menopause rating scale will be used in the research. The intervention group will be given yoga practice two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and control group before and after the research.
Read the detailed description
Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the adoption of yoga practice without health risks by women and its implementation as a lifestyle may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it is aimed to determine the effect of yoga training on menopausal symptoms. The research will be carried out with menopausal women between the ages of 40-60 in Famagusta region. Women will be divided into two groups as intervention and control. Personal information form and menopause rating scale will be used in the research. The intervention group will be given yoga practice two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and control group before and after the research.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaBehavioural
Yoga practice will be done two days a week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Yoga practice will be done two days a week for 10 weeks. Receives: Behavioral: yoga |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
menopause rating scale
It was developed in German by Schneider et al. In 1992 to measure the severity of menopausal symptoms and was adapted to English in 1996. MRT was adapted to Turkish by Gürkan in our country in 2005. There are "0 = None", "1 = Mild", "2 = Moderate", "3 = Severe" and "4 = Very severe" options for each item in the Likert-type scale consisting of 11 items including menopausal complaints. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0, the highest score is 44.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Sep 2020
- Primary completion15 Oct 2020
- Study completion29 Nov 2020
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 MenopauseStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Abiç, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695808
- Sponsor's protocol ID
- g9987n5g
- Other IDs
- Duygu Yılmaz Vefikulucay
- Status last verified
- May 2022
- First submitted
- 28 Dec 2020
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abic A, Yilmaz Vefikulucay D. The Effect of Yoga on Menopause Symptoms: A Randomized Controlled Trial. Holist Nurs Pract. 2024 May-Jun 01;38(3):138-147. doi: 10.1097/HNP.0000000000000646. Epub 2024 May 6.
PubMed 38709129
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga Training on Menopausal Symptoms on Menopausal Women
- ClinicalTrials.gov ID
- NCT04695808
- Acronym / sponsor ID
- g9987n5g
- Conditions
- Menopause
- Keywords
- menopause, yoga, symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 29 Nov 2020 (actual)
- First posted
- 5 Jan 2021 (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.
Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the adoption of yoga practice without health risks by women and its implementation as a lifestyle may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it is aimed to determine the effect of yoga training on menopausal symptoms. The research will be carried out with menopausal women between the ages of 40-60 in Famagusta region. Women will be divided into two groups as intervention and control. Personal information form and menopause rating scale will be used in the research. The intervention group will be given yoga practice two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and control group before and after the research.
Detailed description
Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the adoption of yoga practice without health risks by women and its implementation as a lifestyle may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it is aimed to determine the effect of yoga training on menopausal symptoms. The research will be carried out with menopausal women between the ages of 40-60 in Famagusta region. Women will be divided into two groups as intervention and control. Personal information form and menopause rating scale will be used in the research. The intervention group will be given yoga practice two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and control group before and after the research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: yogaYoga practice will be done two days a week for 10 weeks. |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Willing to participate in research,
- Can read and write in Turkish,
- Open to communication,
- Those who are between the ages of 40-60 and do not experience menstruation for at least one year, Do not use medication to treat menopausal symptoms,
- No diagnosed musculoskeletal disease, no severe heart disease,
Key exclusion criteria (8 listed)
- Refusing to participate in research,
- Can't read and write Turkish,
- Communication is not possible,
- Those who are younger than 40 or older than 60 have experienced menstruation for at least one year
- Using medication for the treatment of menopausal symptoms,
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 |
|---|---|---|
| yogaYoga practice will be done two days a week for 10 weeks. | Behavioural | intervention group |
Primary outcome
menopause rating scale
Time frame: 3 months
It was developed in German by Schneider et al. In 1992 to measure the severity of menopausal symptoms and was adapted to English in 1996. MRT was adapted to Turkish by Gürkan in our country in 2005. There are "0 = None", "1 = Mild", "2 = Moderate", "3 = Severe" and "4 = Very severe" options for each item in the Likert-type scale consisting of 11 items including menopausal complaints. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0, the highest score is 44.
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 27 May 2022.
- Derived from this study: PubMed 38709129Abic A, Yilmaz Vefikulucay D. The Effect of Yoga on Menopause Symptoms: A Randomized Controlled Trial. Holist Nurs Pract. 2024 May-Jun 01;38(3):138-147. doi: 10.1097/HNP.0000000000000646. Epub 2024 May 6.
- Efficacy of yoga for vasomotor symptoms: a randomized controlled trialLink provided by the sponsor.
- Efficacy of omega-3 for vasomotor symptoms treatment: a randomized controlled trialLink provided by the sponsor.
- Hatha Yoga practice decreases menopause symptoms and improves quality of life: A randomized controlled trialLink provided by the sponsor.
- Effects of Yoga and Aerobic Exercise on Actigraphic Sleep Parameters in Menopausal Women with Hot FlashesLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga in people with Menopause, run by Eastern Mediterranean University at 1 site in Cyprus.
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 8 inclusion and 8 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 27 May 2022. 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 Cyprus. 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?
menopause rating scale (time frame: 3 months). 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 NCT04695808, 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 27 May 2022.