The Effect of Health Education and Yoga on Menopause Symptoms and Quality of Life According to Pender's Model

NCT ID: NCT06210412

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life Health Education Yoga Menopause Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

health education and yoga intervention group

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.

Group Type EXPERIMENTAL

health education and yoga intervention group

Intervention Type BEHAVIORAL

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

health education and yoga intervention group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Those who receive hormone replacement therapy
* Those who have undergone surgical menopause
* Having done yoga before
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eastern Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Meltem Altınışık

Senior instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Meltem Altınışık

Role: PRINCIPAL_INVESTIGATOR

eastern meditternean ünivercity

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meltem Altınışık

Famagusta, , Cyprus

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Cyprus

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Meltem Altınışık, 1

Role: CONTACT

05338302826

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Meltem Altınışık, 1

Role: primary

05338302826

hatice bebiş, 2

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23531686 (View on PubMed)

Jones 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.

Reference Type RESULT
PMID: 27261984 (View on PubMed)

Kimura 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.

Reference Type RESULT
PMID: 863905 (View on PubMed)

Kaminetzky H. Sodium in pregnancy: part I. Ariz Med. 1978 Apr;35(4):255-6. No abstract available.

Reference Type RESULT
PMID: 655871 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ETK00-2023-0262

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.