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.
Who can participate
Age range
45 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called Meleis' Transition Theory as the basis for its education and counseling program — can you explain what that approach involves and whether it's been used before for menopausal care?
2Since this trial isn't recruiting yet, how long do you think it might be before it opens, and would it make sense to start any standard treatment for my symptoms in the meantime?
3The trial is measuring changes in perimenopausal depression specifically — if I'm experiencing depression alongside my other symptoms, would you recommend I also see a mental health professional now rather than waiting to see if I qualify for a study like this?
4This trial focuses on education and counseling rather than medication — given the severity of my symptoms, do you think a non-pharmacological program like this could be enough, or might I need other treatments alongside it?
5Because this trial has no assigned phase, it sounds like it may be evaluating the program's effectiveness rather than testing a new drug — does that change the risk profile compared to a typical clinical trial, and what should I understand about what's still unknown?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.