Menopausal Symptoms, Menopause, Perimenopausal Depression
Conditions
Keywords
Menopause, Menopausal transition, Meleis' Transition Theory, Education, Counseling, Menopausal symptoms, Perimenopausal depression, Quality of life, Women's health, Nursing
Brief summary
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
BEHAVIORALMeleis' 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 online messaging platform and follow-up counseling sessions.
OTHERStandard 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.
Sponsors
Ankara Medipol University
Gulhane School of Nursing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
To minimize bias, statistical analyses will be conducted by a blinded statistician who will remain unaware of participant group assignments throughout the analysis process.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menopausal Symptoms | Baseline and Week 16 | Menopausal symptom severity will be assessed using the Menopause Rating Scale. The Menopause Rating Scale is an 11-item instrument evaluating somatic, psychological, and urogenital symptoms. Total scores range from 0 to 44. Higher scores indicate more severe menopausal symptoms. |
| Change in Perimenopausal Depression | Baseline and Week 16 | The Meno-D is a 12-item self-report scale developed to evaluate perimenopausal depressive symptoms. Items are scored on a 4-point Likert scale. Total scores range from 0 to 48, with higher scores indicating greater severity of perimenopausal depression. Scores of 20-24 indicate mild depression requiring follow-up, 24-32 indicate moderate depression requiring treatment, and scores ≥32 indicate severe depression requiring treatment |
| Change in Menopause-Specific Quality of Life | Baseline and Week 16 | The MENQOL-II is a 29-item instrument assessing the impact of menopausal symptoms on quality of life across vasomotor, psychosocial, physical, and sexual domains. Total scores range from 29 to 232, with higher scores indicating a greater negative impact of menopausal symptoms on quality of life. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSENİHA BALCI CEBECİ, Research Assistant
CONTACTGülten GÜVENÇ, Professor
STUDY_DIRECTORSENİHA BALCI CEBECİ, Research Assistant
Ankara Medipol University
Outcome results
None listed