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

NCT07657078 | Not Yet Recruiting

• 1 other identifier: 85859696-604.01.01-9554
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Menopausal Symptoms; Perimenopausal Depression

Keywords

Menopause; Menopausal transition; Meleis' Transition Theory; Education; Counseling; Menopausal symptoms; Perimenopausal depression; Quality of life; Women's health; Nursing

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and Week 16

• 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

  Baseline and Week 16

• 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.

  Baseline and Week 16

Study Arms (2)

Meleis' Transition Theory-Based Education and Counseling Program

EXPERIMENTAL

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.

Behavioral: Meleis' Transition Theory-Based Education and Counseling Program

Standard Information Control

ACTIVE COMPARATOR

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.

Other: Standard Information

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.

Meleis' Transition Theory-Based Education and Counseling Program

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.

Standard Information Control

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Medipol University: lead
• Gulhane School of Nursing: collaborator

Study Sites (1)

Ankara Medipol University

Ankara, 06290, Turkey (Türkiye)

Location

Study Officials

• SENİHA BALCI CEBECİ, Research Assistant

  Ankara Medipol University

  STUDY DIRECTOR

Central Study Contacts

SENİHA BALCI CEBECİ, Research Assistant

CONTACT

+905439132414; senihaabalcii@gmail.com

Gülten GÜVENÇ, Professor

CONTACT

+905366700321; gulten.guvenc@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To minimize bias, statistical analyses will be conducted by a blinded statistician who will remain unaware of participant group assignments throughout the analysis process.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)