Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT04808232
Eligibility Criteria:
Inclusion Criteria:
* Being in the perimenopausal period according to the Staging of Reproductive Aging in Women (STRAW) criteria,
* Women in the early menopause transition phase (STRAW -2). In these women, there is a variation in the duration of the cycles for 7 days or more.
* Women in the late menopausal transition phase (STRAW -1). These women have amenorrhea that lasts 60 days or longer.
* Having entered natural menopause,
* Not receiving hormone replacement therapy in the past and / or currently,
* Not having a diagnosed psychiatric disease,
* Not using alcohol,
* Not using sleeping pills,
* Not doing any other body-mind based practice (meditation, hypnosis, yoga, mindfulness techniques-minfulness, guided imagery technique), Not having a disease that may cause sleep problems and vasomotor symptoms and not receiving medical treatment (thyroid diseases, heart failure, neurological disorders),
* Women health initiative insomnia scale score above 10,
* VAS severity score above 3 for vasomotor synptomes,
* Number of moderate and severe hot flashes over 3 a day,
* To have a smart mobile phone (IOS and Android) and to be using it effectively
Exclusion Criteria:
* Failure to communicate by calling 3 times on different days during the follow-up and the woman not returning to the phone call
* Woman not applying PMRE and health education at most 3 times a week
* The woman leaves the research voluntarily.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT04808232
Study Brief:
Protocol Section:
NCT04808232