- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Demet Öztürk, Phd
- Phone Number: 905068394288
- Email: demett.ozturkk@gmail.com
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06370
- Lokman Hekim University, Ankara, Ankara
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Contact:
- Demet Öztürk, Phd
- Phone Number: 05068394288
- Email: demett.ozturkk@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Urotherapy Knowledge Level
Time Frame: Baseline, two weeks after, 8 weeks after
|
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.
|
Baseline, two weeks after, 8 weeks after
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Urotherapy-Related Lifestyle Behaviors
Time Frame: After 2 weeks and 8 weeks
|
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
|
|
Satisfaction With Urotherapy Education
Time Frame: Baseline
|
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.
|
Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Genetic Diseases, Inborn
- Urological Manifestations
- Genetic Diseases, X-Linked
- Muscular Disorders, Atrophic
- Muscular Dystrophies
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Muscular Dystrophy, Duchenne
- Lower Urinary Tract Symptoms
Other Study ID Numbers
- 2022/12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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