Meleis' Transition Theory-Based Education and Counseling Program in Menopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meleis' Transition Theory-Based Education and Counseling Program, Standard Information.
- Who it may be relevant to
- Registry conditions: Menopause, Menopausal Symptoms, Perimenopausal Depression. Basic parameters: 45 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of a Meleis' Transition Theory-Based Education and Counseling Program on Menopausal Symptoms, Perimenopausal Depression, and Menopause-Specific Quality of Life in Menopausal Women: A Randomized Controlled Trial
Overview
This randomized controlled trial aims to evaluate the effectiveness of a Meleis' Transition Theory-based education and counseling program on menopausal symptoms, perimenopausal depression, and menopause-specific quality of life among naturally menopausal women aged 45 to 55 years. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive a structured four-week education and counseling program based on Meleis' Transition Theory, supported by a secure online messaging group and follow-up counseling sessions. The control group will receive routine care and standard information during the study period and will be offered a one-day educational session after completion of the final assessment. The outcomes will be measured at baseline and Week 16 using the Menopause Rating Scale, the Perimenopausal Depression Scale, and the Menopause-Specific Quality of Life Questionnaire-II.
Detailed description
Menopause is a developmental life transition associated with biological, psychological, and social changes that may negatively affect women's health, well-being, and quality of life. During the menopausal transition, women may experience vasomotor symptoms, sleep disturbances, mood changes, depressive symptoms, urogenital symptoms, and difficulties in adapting to new life roles.
Meleis' Transition Theory provides a conceptual framework for understanding and supporting individuals during life transitions. The theory emphasizes the role of healthcare professionals in facilitating healthy transitions through education, counseling, support, and the strengthening of coping strategies.
This study is designed as a two-arm randomized controlled trial. The study population consists of naturally menopausal women registered at Dikmen Sokullu Mehmet Pasa Family Health Center, a primary healthcare institution affiliated with the Ankara Provincial Health Directorate in Turkey. A total of 114 women who meet the eligibility criteria and provide written informed consent will be recruited.
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using computer-generated simple randomization through Randomizer.org. To minimize bias, statistical analyses will be conducted by a blinded statistician.
Participants in the intervention group will receive a Meleis' Transition Theory-Based Education and Counseling Program. The program consists of four weekly face-to-face educational sessions lasting approximately 90 minutes each. In addition, a secure WhatsApp support group will be established exclusively for participants in the intervention group to provide motivational support and ongoing communication. Follow-up counseling and support meetings will also be conducted during the study period.
The educational content includes menopause and life transitions, facilitators and inhibitors of menopausal transition, physical, psychological, and social effects of menopause, menopausal symptoms, perimenopausal depression, quality of life, social support systems, coping strategies, and self-management skills.
Participants in the control group will receive routine care and standard information during the study period. After completion of the Week 16 final assessment, they will be offered a one-day educational session based on the intervention content.
Outcome assessments will be conducted at baseline and Week 16. Data will be collected using the Personal Information Form, the Menopause Rating Scale, the Perimenopausal Depression Scale, and the Menopause-Specific Quality of Life Questionnaire-II.
Interventions
- Behavioral Meleis' Transition Theory-Based Education and Counseling Program
The intervention is a structured education and counseling program developed according to Meleis' Transition Theory. The program consists of four weekly group sessions lasting approximately 90 minutes each. Educational content includes menopause and life transitions, facilitators and inhibitors of menopausal transition, physical and psychological effects of menopause, social support systems, coping strategies, and self-management skills. Participants also receive ongoing support through a secure - Other Standard Information
Participants receive routine care and standard health information available in primary healthcare settings during the study period. After completion of final assessments, participants are offered a one-day educational session.
Primary outcome measures
- Change in Menopausal Symptoms [Time frame: Baseline and Week 16]
- Change in Perimenopausal Depression [Time frame: Baseline and Week 16]
- Change in Menopause-Specific Quality of Life [Time frame: Baseline and Week 16]
Eligibility criteria
Inclusion criteria
- Female participants aged 45 to 55 years
- Naturally menopausal women
- Menopause duration not exceeding 2 years
- Experiencing menopausal symptoms
- Sexually active
- Able to read and write Turkish
- Willing to participate voluntarily
- Able to provide written informed consent
- Not currently receiving hormone replacement therapy
- No history of psychiatric disorders
- No previous menopause-related education
Exclusion criteria
- Failure to continue participation in the study
- Failure to attend education and counseling sessions
- Withdrawal from the study at any time
- Withdrawal of informed consent
- Loss to follow-up
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Ankara Medipol University — Ankara
Identifiers
NCT: NCT07657078 · 85859696-604.01.01-9554