- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07657078
Meleis' Transition Theory-Based Education and Counseling Program in Menopausal Women
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: SENİHA BALCI CEBECİ, Research Assistant
- Numer telefonu: +905439132414
- E-mail: senihaabalcii@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Gülten GÜVENÇ, Professor
- Numer telefonu: +905366700321
- E-mail: gulten.guvenc@sbu.edu.tr
Lokalizacje studiów
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-
Ankara
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Ankara, Ankara, Turcja (Türkiye), 06290
- Ankara Medipol University
-
Kontakt:
- SENİHA BALCI CEBECİ, Research Assistant
- Numer telefonu: +905439132414
- E-mail: senihaabalcii@gmail.com
-
Kontakt:
- Gülten GÜVENÇ, Professor
- Numer telefonu: +905366700321
- E-mail: gulten.guvenc@sbu.edu.tr
-
Główny śledczy:
- SENİHA BALCI CEBECİ, Research Assistant
-
Pod-śledczy:
- Gülten GÜVENÇ, Professor
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
|
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.
|
|
Aktywny komparator: 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.
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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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Menopausal Symptoms
Ramy czasowe: Baseline and Week 16
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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
|
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Change in Perimenopausal Depression
Ramy czasowe: 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
|
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Change in Menopause-Specific Quality of Life
Ramy czasowe: Baseline and Week 16
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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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: SENİHA BALCI CEBECİ, Research Assistant, Ankara Medipol University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 85859696-604.01.01-9554
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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