- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07599319
Avatar-Based Education and Counseling for Spousal Support During Menopause
Effect of an Avatar-Based Education and Counseling Program on Spousal Support During Menopause
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study aims to evaluate the effectiveness of an avatar-based education and counseling program designed to increase spousal support during menopause. The study will be conducted using a randomized controlled experimental design.
Participants will consist of menopausal women and their spouses. Eligible couples will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured avatar-based education and counseling program delivered online in four sessions, while the control group will receive routine care without additional intervention.
The intervention program focuses on improving knowledge about menopause, enhancing communication and empathy skills, and promoting supportive behaviors among spouses. The program is developed based on prior qualitative findings and relevant literature.
Data will be collected at baseline (pre-test), immediately after the intervention (post-test), and during follow-up assessments at 1, 2, and 3 months. Primary and secondary outcomes will be evaluated using validated measurement tools.
The effectiveness of the intervention will be assessed by comparing changes in outcomes between the intervention and control groups over time.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Fatma Özkar
- Telefonnummer: +905058256967
- E-Mail: ebefatmaozkar@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Nebahat Özerdoğan
- Telefonnummer: +905442395854
- E-Mail: ozerdogannebahat@gmail.com
Studienorte
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Bursa, Türkei (türkiye)
- Rekrutierung
- Bursa Osmangazi Geçit Aile Sağlığı Merkezi
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Kontakt:
- 26 Nolu Geçit Aile Sağlığı Merkezi Aile Sağlığı Merkezi
- Telefonnummer: +905058256967
- E-Mail: ebefatmaozkar@gmail.com
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Unterermittler:
- Fatma Özkar
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Hauptermittler:
- Nebahat Özerdoğan
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Women aged between 45 and 60 years
- Being in the menopausal period
- Married and living with their spouse
- Able to speak, read, and write in Turkish
- Able to communicate effectively
- Willing to participate in the study
- Having a spouse who is willing to participate
- Spouses who have internet access and are able to use digital devices
Exclusion Criteria:
- Women or their spouses with uncontrolled psychiatric disorders requiring treatment
- Women whose spouses have serious physical or mental health problems that may prevent providing support
- Women who experienced early menopause (before age 45)
- Couples who are married but not living together
- Women and their spouses who participated in the first (qualitative) phase of the study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Intervention Group
Participants will receive a 4-session avatar-based education and counseling program delivered online.
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The primary intervention of the study, the education and counseling program, will be delivered to participants assigned to two groups through four online sessions.
During the sessions, an avatar will be used to present the educational and counseling content in order to enable participants to ask questions more comfortably and express themselves, particularly on issues related to their private lives.
In addition, the educational materials will be shared with participants' mobile phones via WhatsApp, and participants will be able to ask questions through WhatsApp communication.
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Kein Eingriff: Control Group
Participants will receive routine care without additional intervention.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Spousal Support Level Measured by the Menopause Spousal Support Scale
Zeitfenster: Baseline and 3 months after intervention
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Spousal support will be assessed using the Menopause Spousal Support Scale.
Total scores will be calculated and compared between groups.
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Baseline and 3 months after intervention
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Menopause Knowledge Level Measured by the Menopause Knowledge Questionnaire
Zeitfenster: Baseline and immediately after intervention
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Menopause knowledge levels of spouses will be assessed using the Menopause Knowledge Questionnaire.
Total scores will be calculated and compared before and after the intervention.
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Baseline and immediately after intervention
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 16.06.2025-111924
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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