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

June 14, 2026 updated by: SENİHA BALCI CEBECİ, Ankara Medipol University

The Effect of a Meleis' Transition Theory-Based Education and Counseling Program on Menopausal Symptoms, Perimenopausal Depression, and Menopause-Specific Quality of Life in Menopausal Women: A Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06290
        • Ankara Medipol University
        • Contact:
        • Contact:
        • Principal Investigator:
          • SENİHA BALCI CEBECİ, Research Assistant
        • Sub-Investigator:
          • Gülten GÜVENÇ, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female participants aged 40 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Meleis' 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.
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.
Other: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Menopausal Symptoms
Time Frame: 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.
Baseline and Week 16
Change in Perimenopausal Depression
Time Frame: Baseline and Week 16
Perimenopausal depression will be assessed using the Perimenopausal Depression Scale. The Perimenopausal Depression Scale is a 12-item instrument developed to assess depressive symptoms during the menopausal transition. The scale evaluates self-related symptoms, cognitive symptoms, somatic symptoms, sleep disturbances, and sexual symptoms. Higher scores indicate greater depression severity.
Baseline and Week 16
Change in Menopause-Specific Quality of Life
Time Frame: Baseline and Week 16
Menopause-specific quality of life will be assessed using the Menopause-Specific Quality of Life Questionnaire-II. The questionnaire includes 29 items and evaluates four domains: vasomotor, psychosocial, physical, and sexual functioning. Higher scores indicate a greater negative impact of menopausal symptoms on quality of life.
Baseline and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Medipol University

Collaborators

Gulhane School of Nursing

Investigators

  • Study Director: SENİHA BALCI CEBECİ, Research Assistant, Ankara Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

June 14, 2026

First Submitted That Met QC Criteria

June 14, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 14, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 85859696-604.01.01-9554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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