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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210412
• Other study ID #: ETK00-2023-0262
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: January 2024
• Source: Eastern Mediterranean University
• Contact: Meltem Altinisik, 1
• Phone: 05338302826
• Email: meltem.altinisik[@]emu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. After obtaining informed consent from the participants, the scales will be applied before and after health education and yoga practice.

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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Education
• Menopause Symptoms
• Quality of Life
• Yoga

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Cyprus	Meltem Altinisik	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Sahin 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).	12 week
Secondary	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.	12 Weeks