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

January 17, 2024 updated by: Meltem Altınışık, Eastern Mediterranean University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining the effect of Health Education and Yoga on the "Yoga Transformation Effect Scale" in Menopausal Women
Time Frame: 12 Weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Mediterranean University

Investigators

  • Principal Investigator: Meltem Altınışık, eastern meditternean ünivercity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Estimated)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ETK00-2023-0262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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