- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Fatma Özkar
- 전화번호: +905058256967
- 이메일: ebefatmaozkar@gmail.com
연구 연락처 백업
- 이름: Nebahat Özerdoğan
- 전화번호: +905442395854
- 이메일: ozerdogannebahat@gmail.com
연구 장소
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Bursa, 터키 (Türkiye)
- 모병
- Bursa Osmangazi Geçit Aile Sağlığı Merkezi
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연락하다:
- 26 Nolu Geçit Aile Sağlığı Merkezi Aile Sağlığı Merkezi
- 전화번호: +905058256967
- 이메일: ebefatmaozkar@gmail.com
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부수사관:
- Fatma Özkar
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수석 연구원:
- Nebahat Özerdoğan
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: Control Group
Participants will receive routine care without additional intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Spousal Support Level Measured by the Menopause Spousal Support Scale
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Menopause Knowledge Level Measured by the Menopause Knowledge Questionnaire
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 16.06.2025-111924
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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