- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Demet Öztürk, Phd
- Telefonnummer: 905068394288
- E-mail: demett.ozturkk@gmail.com
Studiesteder
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Ankara
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Ankara, Ankara, Tyrkiet (Türkiye), 06370
- Lokman Hekim University, Ankara, Ankara
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Kontakt:
- Demet Öztürk, Phd
- Telefonnummer: 05068394288
- E-mail: demett.ozturkk@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Urotherapy Knowledge Level
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Urotherapy-Related Lifestyle Behaviors
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Sygdomme i nervesystemet
- Muskelsygdomme
- Neuromuskulære sygdomme
- Genetiske sygdomme, medfødte
- Urologiske manifestationer
- Genetiske sygdomme, X-forbundet
- Muskellidelser, atrofisk
- Muskeldystrofier
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Muskeldystrofi, Duchenne
- Nedre urinvejssymptomer
Andre undersøgelses-id-numre
- 2022/12
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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