Quality of LifeNCT06210412
The Effect of Health Education and Yoga on Menopause Symptoms and Quality of Life According to Pender's Model
A study testing health education and yoga intervention group in people with Quality of Life and Health Education, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of the study is to examine the effect of health education and yoga intervention prepared according to Pender's Health Promotion Model on menopausal women's "menopause-specific quality of life" compared to routine care. Health education and yoga will be conducted by a certified and responsible investigator. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Quality of Life, Health Education, Yoga
- What is being tested?
- health education and yoga intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Mar 2024to 15 Jun 2024
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Been in menopause for at least 1 year and at most 5 years
- Experiencing menopausal symptoms at least 3 to 4 times a week in the last 3 months
- Those who have no physical disability to practice yoga
- Able to speak and understand Turkish
Who cannot join
- Those who receive hormone replacement therapy
- Those who have undergone surgical menopause
- Having done yoga before
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Meltem Altınışık
Famagusta, 99450
Meltem Altınışık, 1, 05338302826, meltem.altinisik@emu.edu.tr
hatice bebiş, 2, hatice.bebis@emu.edu.tr
About this study
Official title: The Effect of Health Education and Yoga Practices Given According to Pender's Health Promotion Model on Menopausal Symptoms and Quality of Life: A Randomized Controlled Study
The aim of the study is to examine the effect of health education and yoga intervention prepared according to Pender's Health Promotion Model on menopausal women's "menopause-specific quality of life" compared to routine care. Health education and yoga will be conducted by a certified and responsible investigator. After obtaining informed consent from the participants, the scales will be applied before and after health education and yoga practice.
Read the detailed description
It is known that the symptoms experienced by women during menopause affect the woman's quality of life. Many methods have been used in the literature to manage menopause symptoms. However, this study is important to present health education prepared according to Pender's health development model, which will enable women to develop health responsibility awareness, and to manage and alleviate menopausal symptoms of yoga practice planned in this context, to determine its effect on quality of life and to provide a source for literature.
Research hypotheses:
H0= There is no difference between menopause-specific quality of life score averages.
H1= There is a difference between menopause-specific quality of life score averages.
Research question:
1.What are the yoga transformation effect scale scores of the participants in the experimental group after the yoga intervention?
Data Collection Tools Three data collection forms will be used in the research. There is an Introductory Information Form, "Menopause-Specific Quality of Life Scale", and "Yoga Transformation Scale".
- Conditions
- Quality of Life, Health Education, Yoga, Menopause Symptoms
- Being tested
- health education and yoga intervention group
- Keywords
- Menopause symptoms, health education, yoga, quality of life
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health education and yoga intervention groupBehavioural
Health education program based on the Penderin Health Promotion Model; It consists of 10 sessions as a program focused on the management of menopause (increasing the quality of life by teaching physical, psychological and social coping methods in menopause, yoga practices and their importance). In the first week, introduction, first tests (Sociodemographic data form, MÖYKÖ), and general introduction of the program will be made. It is a program in which active education methods (question and answer, role play, demonstration, etc.) are used, with each session planned to last approximately 30 minutes. Final tests will be performed at the end of 12 weeks.
Yoga practice will be carried out as 45-minute sessions 2 days a week, which will last for 12 weeks, following the health education program.12. At the end of the week, MOQÖ and Yoga Transformation Impact Scale will be applied to those who have completed 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| health education and yoga intervention group | Experimental | Health education program based on the Penderin Health Promotion Model; It consists of 10 sessions as a program focused on the management of menopause (increasing the quality of life by teaching physical, psychological and social coping methods in menopause, yoga practices and their importance). In the first week, introduction, first tests (Sociodemographic data form, MÖYKÖ), and general introduction of the program will be made. It is a program in which active education methods (question and answer, role play, demonstration, etc.) are used, with each session planned to last approximately 30 minutes. Final tests will be performed at the end of 12 weeks.
Yoga practice will be carried out as 45-minute sessions 2 days a week, which will last for 12 weeks, following the health education program.12. At the end of the week, MOQÖ and Yoga Transformation Impact Scale will be applied to those who have completed 10 weeks. Receives: Behavioral: health education and yoga intervention group |
| Control group | No intervention | Voluntary consent forms, which will be informed during the interview, and a sociodemographic data form, Menopause-Specific Quality of Life Scale, will be filled in by participants who wish to participate in the research. They will then be invited to undergo final testing after 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Health Education and Yoga on Menopause-Specific Quality of Life in Women
Menopause-Specific Quality of Life Scale-MSQS "Menopause-Specific Quality of Life Scale (MSQQ)" The Turkish validity and reliability of the scale developed by Hilditch et al. in 1996 was tested by Kharbouch and Şahin in 2005. Made by. The scale consists of four domains: vasomotor, psychosocial, physical and sexual, contains 29 Likert-type statements, and as the score obtained from the scale increases, the severity of the complaint increases and the quality of life decreases. Since the average score is used in the total scale, the lowest score that can be obtained from the scale is 0 and the highest score is 6. Sub-domains of the scale; It consists of four subdomains: vasomotor (questions 1-3), psychosocial (questions 4-10), physical (questions 11-26) and sexual (questions 27-29). E-mail permission was obtained for the use of the scale (32).
Measured: 12 week
Secondary outcomes (1)
Determining the effect of Health Education and Yoga on the "Yoga Transformation Effect Scale" in Menopausal Women
Birdee et al. (2015), the Turkish reliability and validity study was conducted by Tetik Küçükelçi (2018). The scale consists of 11 items and three subscales: body (4 items), breath (4 items) and mind (3 items); It measures individuals' yoga self-efficacy levels. An increase in the score obtained from the scale subscale scores indicates a high yoga-self-efficacy status. The Cronbach's alpha value of the scale was 0.88 in the original study; In the current study, it was found to be 0.95 (31). E-mail permission was obtained for the use of the scale.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Parallel groups
- Model description
- The introductory information form and MÖYKÖ tests will be applied. Women with high MÖYKÖ scores will be divided into experimental and control groups using purposeful sampling, according to the lottery method, and those in the experimental group will be contacted by phone and asked to come to the Famagusta Development Academy (MGA) on the day and time determined. Sessions will begin after 12 weeks of health training and Hatha yoga practice are planned. At the end of 12 weeks, final tests will be administered to women who have participated for at least 10 weeks. Those in the control group will be called by phone and invited to MGA Maraş for their first test, and an appointment will be made 12 weeks later for their final test.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Altınışık, Eastern Mediterranean University
- Investigators
- Meltem Altınışık, Principal investigator, eastern meditternean ünivercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210412
- Sponsor's protocol ID
- ETK00-2023-0262
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lambiase MJ, Thurston RC. Physical activity and sleep among midlife women with vasomotor symptoms. Menopause. 2013 Sep;20(9):946-52. doi: 10.1097/GME.0b013e3182844110.
PubMed 23531686Jones SM, Guthrie KA, Reed SD, Landis CA, Sternfeld B, LaCroix AZ, Dunn A, Burr RL, Newton KM. A yoga & exercise randomized controlled trial for vasomotor symptoms: Effects on heart rate variability. Complement Ther Med. 2016 Jun;26:66-71. doi: 10.1016/j.ctim.2016.03.001. Epub 2016 Mar 4.
PubMed 27261984Kimura N, Nagata N. The requirement of guanine nucleotides for glucagon stimulation of adenylate cyclase in rat liver plasma membranes. J Biol Chem. 1977 Jun 10;252(11):3829-35. No abstract available.
PubMed 863905Kaminetzky H. Sodium in pregnancy: part I. Ariz Med. 1978 Apr;35(4):255-6. No abstract available.
PubMed 655871
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Education and Yoga Practices Given According to Pender's Health Promotion Model on Menopausal Symptoms and Quality of Life: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06210412
- Acronym / sponsor ID
- ETK00-2023-0262
- Conditions
- Quality of Life, Health Education, Yoga, Menopause Symptoms
- Keywords
- Menopause symptoms, health education, yoga, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 18 Jan 2024 (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 aim of the study is to examine the effect of health education and yoga intervention prepared according to Pender's Health Promotion Model on menopausal women's "menopause-specific quality of life" compared to routine care. Health education and yoga will be conducted by a certified and responsible investigator. After obtaining informed consent from the participants, the scales will be applied before and after health education and yoga practice.
Detailed description
It is known that the symptoms experienced by women during menopause affect the woman's quality of life. Many methods have been used in the literature to manage menopause symptoms. However, this study is important to present health education prepared according to Pender's health development model, which will enable women to develop health responsibility awareness, and to manage and alleviate menopausal symptoms of yoga practice planned in this context, to determine its effect on quality of life and to provide a source for literature.
Research hypotheses:
H0= There is no difference between menopause-specific quality of life score averages.
H1= There is a difference between menopause-specific quality of life score averages.
Research question:
1.What are the yoga transformation effect scale scores of the participants in the experimental group after the yoga intervention?
Data Collection Tools Three data collection forms will be used in the research. There is an Introductory Information Form, "Menopause-Specific Quality of Life Scale", and "Yoga Transformation Scale".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The introductory information form and MÖYKÖ tests will be applied. Women with high MÖYKÖ scores will be divided into experimental and control groups using purposeful sampling, according to the lottery method, and those in the experimental group will be contacted by phone and asked to come to the Famagusta Development Academy (MGA) on the day and time determined. Sessions will begin after 12 weeks of health training and Hatha yoga practice are planned. At the end of 12 weeks, final tests will be administered to women who have participated for at least 10 weeks. Those in the control group will be called by phone and invited to MGA Maraş for their first test, and an appointment will be made 12 weeks later for their final test.
| Arm | Type | Receives |
|---|---|---|
| health education and yoga intervention group | Experimental | Behavioral: health education and yoga intervention groupHealth education program based on the Penderin Health Promotion Model; It consists of 10 sessions as a program focused on the management of menopause (increasing the quality of life by teaching physical, psychological and social coping methods in menopause, yoga practices and their importance). In the first week, introduction, first tests (Sociodemographic data form, MÖYKÖ), and general introduction of the program will be made. It is a program in which active education methods (question and answer, role play, demonstration, etc.) are used, with each session planned to last approximately 30 minutes. Final tests will be performed at the end of 12 weeks. Yoga practice will be carried out as 45-minute sessions 2 days a week, which will last for 12 weeks, following the health education program.12. At the end of the week, MOQÖ and Yoga Transformation Impact Scale will be applied to those who have completed 10 weeks. |
| Control group | No intervention | –Voluntary consent forms, which will be informed during the interview, and a sociodemographic data form, Menopause-Specific Quality of Life Scale, will be filled in by participants who wish to participate in the research. They will then be invited to undergo final testing after 12 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Been in menopause for at least 1 year and at most 5 years
- Experiencing menopausal symptoms at least 3 to 4 times a week in the last 3 months
- Those who have no physical disability to practice yoga
- Able to speak and understand Turkish
Key exclusion criteria (3 listed)
- Those who receive hormone replacement therapy
- Those who have undergone surgical menopause
- Having done yoga before
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 |
|---|---|---|
| health education and yoga intervention groupHealth education program based on the Penderin Health Promotion Model; It consists of 10 sessions as a program focused on the management of menopause (increasing the quality of life by teaching physical, psychological and social coping methods in menopause, yoga practices and their importance). In the first week, introduction, first tests (Sociodemographic data form, MÖYKÖ), and general introduction of the program will be made. It is a program in which active education methods (question and answer, role play, demonstration, etc.) are used, with each session planned to last approximately 30 minutes. Final tests will be performed at the end of 12 weeks. Yoga practice will be carried out as 45-minute sessions 2 days a week, which will last for 12 weeks, following the health education program.12. At the end of the week, MOQÖ and Yoga Transformation Impact Scale will be applied to those who have completed 10 weeks. | Behavioural | health education and yoga intervention group |
Primary outcome
The Effect of Health Education and Yoga on Menopause-Specific Quality of Life in Women
Time frame: 12 week
Menopause-Specific Quality of Life Scale-MSQS "Menopause-Specific Quality of Life Scale (MSQQ)" The Turkish validity and reliability of the scale developed by Hilditch et al. in 1996 was tested by Kharbouch and Şahin in 2005. Made by. The scale consists of four domains: vasomotor, psychosocial, physical and sexual, contains 29 Likert-type statements, and as the score obtained from the scale increases, the severity of the complaint increases and the quality of life decreases. Since the average score is used in the total scale, the lowest score that can be obtained from the scale is 0 and the highest score is 6. Sub-domains of the scale; It consists of four subdomains: vasomotor (questions 1-3), psychosocial (questions 4-10), physical (questions 11-26) and sexual (questions 27-29). E-mail permission was obtained for the use of the scale (32).
1 secondary outcome
Determining the effect of Health Education and Yoga on the "Yoga Transformation Effect Scale" in Menopausal Women
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Results publication: PubMed 23531686Lambiase MJ, Thurston RC. Physical activity and sleep among midlife women with vasomotor symptoms. Menopause. 2013 Sep;20(9):946-52. doi: 10.1097/GME.0b013e3182844110.
- Results publication: PubMed 27261984Jones SM, Guthrie KA, Reed SD, Landis CA, Sternfeld B, LaCroix AZ, Dunn A, Burr RL, Newton KM. A yoga & exercise randomized controlled trial for vasomotor symptoms: Effects on heart rate variability. Complement Ther Med. 2016 Jun;26:66-71. doi: 10.1016/j.ctim.2016.03.001. Epub 2016 Mar 4.
- Results publication: PubMed 863905Kimura N, Nagata N. The requirement of guanine nucleotides for glucagon stimulation of adenylate cyclase in rat liver plasma membranes. J Biol Chem. 1977 Jun 10;252(11):3829-35. No abstract available.
- Results publication: PubMed 655871Kaminetzky H. Sodium in pregnancy: part I. Ariz Med. 1978 Apr;35(4):255-6. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
Meltem Altınışık principal investigator
eastern meditternean ünivercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education and yoga intervention group in people with Quality of Life and Health Education, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meltem Altınışık, 1 (05338302826, meltem.altinisik@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Health Education and Yoga on Menopause-Specific Quality of Life in Women (time frame: 12 week). 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 NCT06210412, which also lists 4 linked publications.
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 18 Jan 2024.