- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: SENİHA BALCI CEBECİ, Research Assistant
- Telefonnummer: +905439132414
- E-mail: senihaabalcii@gmail.com
Undersøgelse Kontakt Backup
- Navn: Gülten GÜVENÇ, Professor
- Telefonnummer: +905366700321
- E-mail: gulten.guvenc@sbu.edu.tr
Studiesteder
-
-
Ankara
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Ankara, Ankara, Tyrkiet (Türkiye), 06290
- Ankara Medipol University
-
Kontakt:
- SENİHA BALCI CEBECİ, Research Assistant
- Telefonnummer: +905439132414
- E-mail: senihaabalcii@gmail.com
-
Kontakt:
- Gülten GÜVENÇ, Professor
- Telefonnummer: +905366700321
- E-mail: gulten.guvenc@sbu.edu.tr
-
Ledende efterforsker:
- SENİHA BALCI CEBECİ, Research Assistant
-
Underforsker:
- Gülten GÜVENÇ, Professor
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Menopausal Symptoms
Tidsramme: 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
Tidsramme: 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
|
|
Change in Menopause-Specific Quality of Life
Tidsramme: Baseline and Week 16
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: SENİHA BALCI CEBECİ, Research Assistant, Ankara Medipol University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 85859696-604.01.01-9554
Plan for individuelle deltagerdata (IPD)
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