Meleis' Transition Theory-Based Education and Counseling Program in Menopausal Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorAnkara Medipol University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged 45 to 55 years
Naturally menopausal women
Menopause duration not exceeding 2 years
Experiencing menopausal symptoms
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Meleis' Transition Theory-Based Education and Counseling Program
BehavioralThe 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.
Standard Information
Other interventionParticipants 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.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Meleis' Transition Theory-Based Education and Counseling ProgramExperimental treatment 1 intervention
Group B: Standard Information ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Menopausal Symptoms
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.
Time frame
Baseline and Week 162
Change in Perimenopausal Depression
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
Time frame
Baseline and Week 163
Change in Menopause-Specific Quality of Life
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.
Time frame
Baseline and Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ankara Medipol University
Lead sponsor
Gulhane School of Nursing
Collaborator
Source ClinicalTrials.gov
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