- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fatma Özkar
- Numéro de téléphone: +905058256967
- E-mail: ebefatmaozkar@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Nebahat Özerdoğan
- Numéro de téléphone: +905442395854
- E-mail: ozerdogannebahat@gmail.com
Lieux d'étude
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Bursa, Turquie (Türkiye)
- Recrutement
- Bursa Osmangazi Geçit Aile Sağlığı Merkezi
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Contact:
- 26 Nolu Geçit Aile Sağlığı Merkezi Aile Sağlığı Merkezi
- Numéro de téléphone: +905058256967
- E-mail: ebefatmaozkar@gmail.com
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Sous-enquêteur:
- Fatma Özkar
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Chercheur principal:
- Nebahat Özerdoğan
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Control Group
Participants will receive routine care without additional intervention.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Spousal Support Level Measured by the Menopause Spousal Support Scale
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Menopause Knowledge Level Measured by the Menopause Knowledge Questionnaire
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 16.06.2025-111924
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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