- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatma Özkar
- Phone Number: +905058256967
- Email: ebefatmaozkar@gmail.com
Study Contact Backup
- Name: Nebahat Özerdoğan
- Phone Number: +905442395854
- Email: ozerdogannebahat@gmail.com
Study Locations
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-
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Bursa, Turkey (Türkiye)
- Recruiting
- Bursa Osmangazi Geçit Aile Sağlığı Merkezi
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Contact:
- 26 Nolu Geçit Aile Sağlığı Merkezi Aile Sağlığı Merkezi
- Phone Number: +905058256967
- Email: ebefatmaozkar@gmail.com
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Sub-Investigator:
- Fatma Özkar
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Principal Investigator:
- Nebahat Özerdoğan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants will receive a 4-session avatar-based education and counseling program delivered online.
|
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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No Intervention: Control Group
Participants will receive routine care without additional intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Spousal Support Level Measured by the Menopause Spousal Support Scale
Time Frame: Baseline and 3 months after intervention
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Menopause Knowledge Level Measured by the Menopause Knowledge Questionnaire
Time Frame: Baseline and immediately after intervention
|
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.
|
Baseline and immediately after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16.06.2025-111924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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