NCT07599319

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2025Mar 2027

Study Start

First participant enrolled

July 15, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

May 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 20, 2026

Last Update Submit

May 14, 2026

Conditions

Menopause

Keywords

Spousal SupportEducationMenopause EducationCounselingAvatar-Based Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 3 months after intervention

Secondary Outcomes (1)

  • Change in Menopause Knowledge Level Measured by the Menopause Knowledge Questionnaire

    Baseline and immediately after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive a 4-session avatar-based education and counseling program delivered online.

Other: Avatar-supported menopause education and counseling program

Control Group

NO INTERVENTION

Participants will receive routine care without additional intervention.

Interventions

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.

Intervention Group

Eligibility Criteria

Age45 Years - 60 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbiologically reproductive capable women and their male partners
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Osmangazi Geçit Aile Sağlığı Merkezi

Bursa, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Fatma Özkar

CONTACT

+905058256967ebefatmaozkar@gmail.com

Nebahat Özerdoğan

CONTACT

+905442395854ozerdogannebahat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife

Study Record Dates

First Submitted

April 20, 2026

First Posted

May 20, 2026

Study Start

July 15, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

March 15, 2027

Last Updated

May 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data collection for the study has not yet actively begun.

Locations

TU(1)