MenopauseNCT07657078
Meleis' Transition Theory-Based Education and Counseling Program in Menopausal Women
A study testing Meleis' Transition Theory-Based Education and Counseling Program and Standard Information in people with Menopause and Menopausal Symptoms, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Menopause, Menopausal Symptoms, Perimenopausal Depression
- What is being tested?
- Meleis' Transition Theory-Based Education and Counseling Program and Standard Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Medipol University
Ankara, 06290
SENİHA BALCI CEBECİ, Research Assistant, +905439132414, senihaabalcii@gmail.com
Gülten GÜVENÇ, Professor, +905366700321, gulten.guvenc@sbu.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Menopause, Menopausal Symptoms, Perimenopausal Depression
- Being tested
- Meleis' Transition Theory-Based Education and Counseling Program, Standard Information
- Keywords
- Menopause, Menopausal transition, Meleis' Transition Theory, Education, Counseling, Menopausal symptoms, Perimenopausal depression, Quality of life, Women's health, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meleis' Transition Theory-Based Education and Counseling ProgramBehavioural
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 InformationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane School of Nursing
- Responsible party
- Principal investigator, SENİHA BALCI CEBECİ, Ankara Medipol University
- Investigators
- SENİHA BALCI CEBECİ, Research Assistant, Study director, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657078
- Sponsor's protocol ID
- 85859696-604.01.01-9554
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07657078
- Acronym / sponsor ID
- 85859696-604.01.01-9554
- Conditions
- Menopause, Menopausal Symptoms, Perimenopausal Depression
- Keywords
- Menopause, Menopausal transition, Meleis' Transition Theory, Education, Counseling, Menopausal symptoms, Perimenopausal depression, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Collaborators
- Gulhane School of Nursing
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Meleis' Transition Theory-Based Education and Counseling Program | Experimental | Behavioral: Meleis' Transition Theory-Based Education and Counseling ProgramParticipants 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. |
| Standard Information Control | Active comparator | Other: Standard InformationParticipants 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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female participants aged 45 to 55 years
- Naturally menopausal women
- Menopause duration not exceeding 2 years
- Experiencing menopausal symptoms
- Sexually active
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meleis' Transition Theory-Based Education and Counseling ProgramThe 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. | Behavioural | Meleis' Transition Theory-Based Education and Counseling Program |
| Standard InformationParticipants 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. | Other | Standard Information Control |
Primary outcome
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.
Change in Perimenopausal Depression
Time frame: Baseline and Week 16
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
Change in Menopause-Specific Quality of Life
Time frame: Baseline and Week 16
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Menopause
RecruitingObservational study
Health, Imaging, and Cognition Across the Menopausal Transition
Menopause
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruiting
Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
Menopause, Vasomotor Symptoms (VMS)
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
RecruitingObservational study
QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy
Cancer, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SENİHA BALCI CEBECİ, Research Assistant study director
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meleis' Transition Theory-Based Education and Counseling Program and Standard Information in people with Menopause and Menopausal Symptoms, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SENİHA BALCI CEBECİ, Research Assistant (+905439132414, senihaabalcii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Menopausal Symptoms (time frame: Baseline and Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.