Ankara Medipol University
Ankara, 06290, Turkey (Türkiye)
NCT Number: NCT07657078
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.
Trial opening soon.
Get Notified45 year–55 year
Female
Interventional
Not applicable
Ankara, 06290, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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
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.
Trial opening soon.
Get NotifiedAnkara Medipol University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07771946
Blindness, Eye Diseases
Ankara, Altindağ, Turkey (Türkiye)
View Trial DetailsNCT07752641
Hot Flashes, Menopausal Symptoms
Madrid, Spain
View Trial DetailsNCT07412093
Anxiety, Anxiety Disorders
Sivas, Merkez, Turkey (Türkiye)
View Trial DetailsNCT07800793
Behavior, Behavioral Symptoms
Istanbul, Mrs, Turkey (Türkiye)
View Trial Details