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Empowering Mothers of Children With Nocturnal Enuresis to Improve Knowledge, Practices, and Quality of Life (EMNE)

9 de agosto de 2026 actualizado por: Manal Mohamed Elsawy, Cairo University

Effect of Empowering Mothers of Children With Nocturnal Enuresis on Knowledge, Practices and Quality of Life

This study aimed to evaluate the effect of the empowerment program on the knowledge, practices, and quality of life of mothers of children with nocturnal enuresis in a two-arm randomized controlled trial.

Descripción general del estudio

Estado

Terminado

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

Intervencionista

Inscripción (Actual)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Cairo, Egipto
        • Faculty of nursing Cairo University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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).
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:
  • Structured Educational Empowerment Program
  • Family Empowerment Program
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mothers' Knowledge Regarding Nocturnal Enuresis
Periodo de tiempo: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)

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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mothers' Self-Reported Practices Regarding Nocturnal Enuresis
Periodo de tiempo: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)

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)
Mothers' Quality of Life
Periodo de tiempo: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)

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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de septiembre de 2024

Finalización primaria (Actual)

27 de marzo de 2025

Finalización del estudio (Actual)

29 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de agosto de 2026

Publicado por primera vez (Actual)

7 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de agosto de 2026

Última verificación

1 de agosto de 2024

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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