MenopauseNCT07599319
Avatar-Based Education and Counseling for Spousal Support During Menopause
A study testing Avatar-supported menopause education and counseling program in people with Menopause, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of an avatar-based education and counseling program in increasing spousal support during menopause. The study will include menopausal women and their spouses. Participants will be assigned to intervention and control groups. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Avatar-supported menopause education and counseling program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa Osmangazi Geçit Aile Sağlığı Merkezi
Bursa
26 Nolu Geçit Aile Sağlığı Merkezi Aile Sağlığı Merkezi, +905058256967, ebefatmaozkar@gmail.com
Fatma Özkar
About this study
Official title: Effect of an Avatar-Based Education and Counseling Program on Spousal Support During Menopause
This study aims to evaluate the effectiveness of an avatar-based education and counseling program in increasing spousal support during menopause. The study will include menopausal women and their spouses. Participants will be assigned to intervention and control groups. The intervention group will receive a structured online avatar-based education and counseling program, while the control group will receive routine care. Outcomes will be assessed before and after the intervention, as well as during follow-up periods.
Read the 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.
- Conditions
- Menopause
- Being tested
- Avatar-supported menopause education and counseling program
- Keywords
- Spousal Support, Education, Menopause Education, Counseling, Avatar-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatar-supported menopause education and counseling programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive a 4-session avatar-based education and counseling program delivered online. Receives: Other: Avatar-supported menopause education and counseling program |
| Control Group | No intervention | Participants will receive routine care without additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spousal Support Level Measured by the Menopause Spousal Support Scale
Spousal support will be assessed using the Menopause Spousal Support Scale. Total scores will be calculated and compared between groups.
Measured: Baseline and 3 months after intervention
Secondary outcomes (1)
Change in Menopause Knowledge Level Measured by the Menopause Knowledge Questionnaire
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.
Measured: Baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start15 Jul 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA ÖZKAR, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599319
- Sponsor's protocol ID
- 16.06.2025-111924
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collection for the study has not yet actively begun.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Avatar-Based Education and Counseling Program on Spousal Support During Menopause
- ClinicalTrials.gov ID
- NCT07599319
- Acronym / sponsor ID
- 16.06.2025-111924
- Conditions
- Menopause
- Keywords
- Spousal Support, Education, Menopause Education, Counseling, Avatar-Based Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of an avatar-based education and counseling program in increasing spousal support during menopause. The study will include menopausal women and their spouses. Participants will be assigned to intervention and control groups. The intervention group will receive a structured online avatar-based education and counseling program, while the control group will receive routine care. Outcomes will be assessed before and after the intervention, as well as during follow-up periods.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Avatar-supported menopause education and counseling programParticipants will receive a 4-session avatar-based education and counseling program delivered online. |
| Control Group | No intervention | –Participants will receive routine care without additional intervention. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatar-supported menopause education and counseling programThe 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. | Other | Intervention Group |
Primary outcome
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.
1 secondary outcome
Change in Menopause Knowledge Level Measured by the Menopause Knowledge Questionnaire
Time frame: Baseline and immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. Data collection for the study has not yet actively begun.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avatar-supported menopause education and counseling program in people with Menopause, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Özkar (+905058256967, ebefatmaozkar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spousal Support Level Measured by the Menopause Spousal Support Scale (time frame: Baseline and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.