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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- Faculty of nursing Cairo University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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
Otros nombres:
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mothers' Knowledge Regarding Nocturnal Enuresis
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mothers' Self-Reported Practices Regarding Nocturnal Enuresis
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Desordenes mentales
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Trastornos de la micción
- Síntomas de comportamiento
- Trastornos de Eliminación
- Comportamiento
- Comportamiento social
- Enuresis
- Orina nocturna al dormir
- Empoderamiento
Otros números de identificación del estudio
- 05-10-2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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