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临床试验/NCT07753304
NCT07753304已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Mothers' Knowledge Regarding Nocturnal Enuresis

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Empowerment Program

Experimental

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).

干预措施: Mother Empowerment Program for Nocturnal Enuresis (Behavioral)

Usual Care (Waitlist Control)

No Intervention

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.

结局指标

主要结局

Mothers' Knowledge Regarding Nocturnal Enuresis

时间窗: 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%).

次要结局

  • Mothers' Self-Reported Practices Regarding Nocturnal Enuresis(Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2))
  • Mothers' Quality of Life(Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manal Mohamed Elsawy

Assistant professor

Cairo University

研究点 (1)

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