- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07753304
Empowering Mothers of Children With Nocturnal Enuresis to Improve Knowledge, Practices, and Quality of Life (EMNE)
Effect of Empowering Mothers of Children With Nocturnal Enuresis on Knowledge, Practices and Quality of Life
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Nocturnal enuresis is a common pediatric condition that adversely affects children's physical, psychological, and social well-being, as well as the quality of life of their families. Mothers play a central role in the day-to-day management of children with nocturnal enuresis; however, insufficient knowledge and inappropriate management practices may reduce the effectiveness of treatment and increase the family burden.
Objective: This randomized controlled trial aimed to evaluate the effectiveness of an empowerment program for mothers of children with nocturnal enuresis in improving their knowledge, self-reported practices, and quality of life.
Methods: A two-arm parallel randomized controlled trial was conducted at the Outpatient Urinary Incontinence Clinic, Centre for Social and Preventive Medicine, Cairo University, Egypt. A total of 200 eligible mothers were randomly allocated to either an intervention group that received the structured empowerment program or a wait-list control group that received routine care during the study period. Outcomes were assessed at baseline (T0), four weeks after the intervention (T1), and three months after the intervention (T2).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Cairo, Egypt
- Faculty of nursing Cairo University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria Mothers aged 18 years or older. Mothers of school-age children diagnosed with nocturnal enuresis. Child aged 6-12 years attending the outpatient urinary incontinence clinic at the Centre for Social and Preventive Medicine, Cairo University.
Able to communicate in Arabic. Willing to participate and provide written informed consent. Available to complete baseline, post-intervention (4 weeks), and 3-month follow-up assessments.
Exclusion Criteria Mothers of children with secondary nocturnal enuresis caused by serious neurological, endocrine, or structural urinary tract disorders.
Mothers whose children have severe cognitive impairment or medical conditions preventing participation in the educational program.
Mothers currently participating in another structured educational or behavioral intervention related to nocturnal enuresis.
Mothers unwilling or unable to provide informed consent or complete study assessments.
Mothers planning to relocate or unlikely to complete follow-up evaluations.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Empowerment Program
Mothers assigned to this arm receive a structured empowerment program for managing children with nocturnal enuresis.
The program consists of 30-minute small-group educational sessions (3-5 mothers per group) delivered in Arabic using lectures, discussions, and an educational booklet developed by the researchers.
The program covers the definition, types, risk factors, diagnosis, complications, and evidence-based management of nocturnal enuresis, with the aim of improving maternal knowledge, caregiving practices, and quality of life.
Participants are assessed at baseline (T0), 4 weeks (T1), and 3 months (T2).
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The intervention is a structured nurse-led behavioral empowerment program designed for mothers of school-age children with nocturnal enuresis.
The program is delivered in Arabic through 30-minute small-group sessions (3-5 mothers per group) using interactive teaching, discussion, and an educational booklet developed by the research team.
The educational content includes the definition and types of nocturnal enuresis, causes and risk factors, diagnostic evaluation, complications, behavioral management strategies, fluid management, bladder training, reward systems, alarm therapy, medication adherence, hygiene measures, and family support strategies.
Mothers receive the educational booklet at the completion of the sessions for continued home reference.
The intervention aims to improve maternal knowledge, caregiving practices, and family quality of life.
Participants are evaluated at baseline (T0), 4 weeks after the intervention (T1), and 3 months after the intervention
Ostatní jména:
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Žádný zásah: Usual Care (Waitlist Control)
Mothers assigned to this arm receive the routine care provided at the outpatient urinary incontinence clinic during the study period without the structured empowerment program.
Participants complete the same outcome assessments at baseline (T0), 4 weeks (T1), and 3 months (T2).
After completion of the T2 assessment, mothers in the waitlist control group receive the full empowerment program.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mothers' Knowledge Regarding Nocturnal Enuresis
Časové okno: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
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Mothers' knowledge regarding nocturnal enuresis will be assessed using the researcher-developed Nocturnal Enuresis Structured Knowledge Questionnaire (15 items). Knowledge scoring system: "Two" scores were given for a completely correct answer, "one" score for an incomplete correct answer, and "zero" for an incorrect or unknown answer. The higher scores reflect higher levels of knowledge about nocturnal enuresis. The total knowledge scores are categorized into three levels: unsatisfactory knowledge (less than 50%), partially satisfactory knowledge (50%-75%), and satisfactory knowledge (more than 75%). |
Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mothers' Self-Reported Practices Regarding Nocturnal Enuresis
Časové okno: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
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Mothers' self-reported practices will be assessed using a researcher-developed 15-item checklist covering behavioral management practices, including fluid management, bladder training, reward systems, alarm therapy, hygiene, and follow-up care. Each performed practice is scored as 1 and each non-performed practice as 0. Higher scores indicate better practice. Self-reported practices scoring system: Each item was given one score if performed, and a score of zero for actions not performed. Total scores were classified as follows: poor practices (less than 50%), fair practices (50%-75%), and good practices (more than 75%). |
Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
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Mothers' Quality of Life
Časové okno: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
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Mothers' quality of life will be measured using the Modified Pediatric Enuresis Module on Quality of Life-Short Form (PEMQOL-SF). The instrument consists of 16 items evaluating the impact of nocturnal enuresis on the child and family. Scores are transformed to a 0-100 scale according to the instrument scoring guidelines. The PEMQOL-Short Form is made up of 16 questions: 7 questions concerning the impact on the child's well-being (child impact scale) and 9 questions concerning its impact on the family's emotional and social well-being (family impact scale). Response options for both scales have five levels each: A lot, Quite a bit, Some, A little bit, and Not at all. For ease of interpretation, the raw scale scores are converted to a 0-100 continuum using a standard mathematical formula. A score of more than 50 is considered a significant effect on psychological well-being. |
Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Tsuji S, Kaneko K. Management of treatment-resistant nocturnal enuresis. Pediatr Int. 2023 Jan-Dec;65(1):e15573. doi: 10.1111/ped.15573.
- Kamperis K. Nocturnal enuresis in children: The role of arginine-vasopressin. Handb Clin Neurol. 2021;181:289-297. doi: 10.1016/B978-0-12-820683-6.00021-X.
- Cammisa I, Zona M, Ferrara P. Management of nocturnal enuresis in children. Minerva Pediatr (Torino). 2025 Aug;77(4):360-371. doi: 10.23736/S2724-5276.25.07812-7. Epub 2025 Feb 18.
- Guzman JA, Palmer LS. Nocturnal Enuresis. Pediatr Rev. 2024 Aug 1;45(8):479-481. doi: 10.1542/pir.2023-006166. No abstract available.
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Primární dokončení (Aktuální)
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Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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