- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Demet Öztürk, Phd
- Telefonnummer: 905068394288
- E-Mail: demett.ozturkk@gmail.com
Studienorte
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Ankara
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Ankara, Ankara, Türkei (türkiye), 06370
- Lokman Hekim University, Ankara, Ankara
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Kontakt:
- Demet Öztürk, Phd
- Telefonnummer: 05068394288
- E-Mail: demett.ozturkk@gmail.com
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Urotherapy Knowledge Level
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Urotherapy-Related Lifestyle Behaviors
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Bewegungsapparates
- Erkrankungen des Nervensystems
- Muskelerkrankungen
- Neuromuskuläre Erkrankungen
- Genetische Krankheiten, angeboren
- Urologische Manifestationen
- Genetische Krankheiten, X-gebunden
- Muskelerkrankungen, atrophisch
- Muskeldystrophien
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Muskeldystrophie, Duchenne
- Symptome der unteren Harnwege
Andere Studien-ID-Nummern
- 2022/12
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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