- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07821125
Urotherapy Education for Families of Children With Duchenne Muscular Dystrophy
Effects of Urotherapy Education Provided to Families of Children With Duchenne Muscular Dystrophy on Knowledge, Lifestyle Changes, and Training Satisfaction
연구 개요
상세 설명
Duchenne muscular dystrophy (DMD) is a progressive neuromuscular disorder that may also be accompanied by lower urinary tract symptoms. Urotherapy is a conservative, non-pharmacological approach that includes education on bladder and bowel function, appropriate voiding and defecation habits, lifestyle modifications, and strategies for managing lower urinary tract symptoms.
This prospective interventional study will evaluate the effects of an online urotherapy education program provided to families of children with DMD. The education will be delivered remotely in a single session of approximately three hours. Participants will be assessed before the education, immediately after the education, and two weeks later and 2 months after. The study will examine changes in parents' knowledge and awareness of urotherapy-related behaviors and lifestyle practices, as well as their satisfaction with the education provided.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Demet Öztürk, Phd
- 전화번호: 905068394288
- 이메일: demett.ozturkk@gmail.com
연구 장소
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06370
- Lokman Hekim University, Ankara, Ankara
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연락하다:
- Demet Öztürk, Phd
- 전화번호: 05068394288
- 이메일: demett.ozturkk@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Being a parent or caregiver of a child diagnosed with Duchenne muscular dystrophy.
- Volunteering to participate in the study.
- Providing informed consent.
- Being able to participate in the online urotherapy education and complete the study assessments.
Exclusion Criteria:
- Not completing the urotherapy education session.
- Not completing the required study assessments.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Urotherapy Education Group
Participants in this arm will receive a single online urotherapy education session lasting approximately three hours.
The education will include information on lower urinary tract anatomy and function, bladder and bowel symptoms, appropriate voiding and defecation habits and postures, lifestyle modifications, fluid intake, and strategies for managing lower urinary tract symptoms.
Knowledge and awareness will be assessed before the education, immediately after the education, and two weeks later and eight weeks later, and satisfaction with the education will be evaluated after the session.
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Participants will receive a single online urotherapy education session lasting approximately three hours.
The education will include information about lower urinary tract anatomy and function, lower urinary tract symptoms, bladder and bowel habits, appropriate voiding and defecation postures, scheduled voiding and defecation, fluid intake, lifestyle modifications, pelvic floor muscle awareness, and general strategies for managing lower urinary tract symptoms.
Educational materials may include visual materials, videos, and other supporting resources.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Urotherapy Knowledge Level
기간: Baseline, two weeks after, 8 weeks after
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Parents' knowledge of urotherapy will be assessed using a 10-item knowledge test developed by the researchers based on the educational content.
The test consists of five true/false and five multiple-choice questions.
Each correct answer is worth 10 points, resulting in a total score ranging from 0 to 100.
Higher scores indicate a higher level of knowledge about urotherapy.
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Baseline, two weeks after, 8 weeks after
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Urotherapy-Related Lifestyle Behaviors
기간: After 2 weeks and 8 weeks
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Urotherapy-related lifestyle behaviors will be assessed using awareness questions developed by the researchers.
The questions evaluate voiding frequency, defecation frequency, daily water intake, consumption of tea, coffee, and carbonated beverages, appropriate toileting posture, and implementation of lifestyle recommendations introduced during the urotherapy education.
Changes in these behaviors after the education will be evaluated.
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After 2 weeks and 8 weeks
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Satisfaction With Urotherapy Education
기간: Baseline
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Satisfaction with the urotherapy education will be assessed using an 8-item satisfaction questionnaire developed by the researchers.
Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
The total score ranges from 8 to 40, with higher scores indicating greater satisfaction with the education.
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Baseline
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2022/12
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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