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

NCT06210412 | Unknown DMC

• 1 other identifier: ETK00-2023-0262
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life; Health Education; Yoga; Menopause Symptoms

Keywords

Menopause symptoms; health education; yoga; quality of life

Outcome Measures

Primary Outcomes (1)

• 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).

  12 week

Secondary Outcomes (1)

• Determining the effect of Health Education and Yoga on the "Yoga Transformation Effect Scale" in Menopausal Women

  12 Weeks

Study Arms (2)

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.

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.

Interventions

health education and yoga intervention group 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.

health education and yoga intervention group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: menopause womans
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those who receive hormone replacement therapy
• Those who have undergone surgical menopause
• Having done yoga before

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Meltem Altınışık

Famagusta, 99450, Cyprus

Location

Related Publications (4)

• 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.

  PMID: 23531686 RESULT

• 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.

  PMID: 27261984 RESULT

• 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.

  PMID: 863905 RESULT

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

  PMID: 655871 RESULT

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Meltem Altınışık

  eastern meditternean ünivercity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meltem Altınışık, 1

CONTACT

05338302826; meltem.altinisik@emu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior instructor

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 18, 2024
• Study Start: March 1, 2024
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR

Locations

CY (1)