Meleis' Transition Theory-Based Education and Counseling Program in Menopausal Women

Sponsor
Ankara Medipol University
Study ID
NCT07657078
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Meleis' Transition Theory-Based Education and Counseling Program — BEHAVIORAL
    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.
  • Standard Information — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Oct 15, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Meleis' Transition Theory-Based Education and Counseling Program
    Participants assigned to the intervention group will receive a structured education and counseling program based on Meleis' Transition Theory. The intervention consists of four weekly face-to-face educational sessions lasting approximately 90 minutes each, a secure online messaging support group, continuous motivational support, and follow-up counseling sessions throughout the study period.
  • Active Comparator: Standard Information Control
    Participants assigned to the control group will receive routine care and standard information during the study period. Following completion of the Week 16 assessment, participants will be offered a one-day educational session based on the intervention content.

Primary Outcome Measure

Change in Menopausal Symptoms [ Time Frame: Baseline and Week 16 ]

Central Contacts

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