- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: SENİHA BALCI CEBECİ, Research Assistant
- Номер телефона: +905439132414
- Электронная почта: senihaabalcii@gmail.com
Учебное резервное копирование контактов
- Имя: Gülten GÜVENÇ, Professor
- Номер телефона: +905366700321
- Электронная почта: gulten.guvenc@sbu.edu.tr
Места учебы
-
-
-
Ankara, Турция (Туркие), 06290
- Ankara Medipol University
-
Контакт:
- SENİHA BALCI CEBECİ, Research Assistant
- Номер телефона: +905439132414
- Электронная почта: senihaabalcii@gmail.com
-
Контакт:
- Gülten GÜVENÇ, Professor
- Номер телефона: +905366700321
- Электронная почта: gulten.guvenc@sbu.edu.tr
-
Главный следователь:
- SENİHA BALCI CEBECİ, Research Assistant
-
Младший исследователь:
- Gülten GÜVENÇ, Professor
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Активный компаратор: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Menopausal Symptoms
Временное ограничение: 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
Временное ограничение: 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
|
Baseline and Week 16
|
|
Change in Menopause-Specific Quality of Life
Временное ограничение: 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.
|
Baseline and Week 16
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Директор по исследованиям: SENİHA BALCI CEBECİ, Research Assistant, Ankara Medipol University
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 85859696-604.01.01-9554
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .