Using Tele-rehabilitation on Management of Pediatric Nocturnal Enuresis: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- number of wet nights/week
研究概览
简要总结
Objective:
To evaluate the effectiveness of telerehabilitation (via lifestyle and dietary advice) in managing primary nocturnal enuresis (bedwetting) in children aged 5-10 years.
Background:
Nocturnal enuresis is common in children and can be influenced by genetic, hormonal, and bladder-related factors. Treatment includes behavioral, pharmacological, and psychological approaches. Telerehabilitation-remote delivery of care-emerged during the COVID-19 pandemic as a promising tool for maintaining continuity of care.
Methodology:
Design: Randomized Controlled Trial
Participants: Children aged 5-10 with primary NE (wetting ≥4 nights/week), recruited online.
Exclusion: Children with secondary NE due to medical conditions or those on medication.
Groups:
Study group: Received telerehabilitation (lifestyle + dietary guidance).
Control group: No telerehabilitation.
Duration: 3 weeks (1 week baseline, 1 week intervention, 1 week follow-up)
Assessment:
Number of wet nights per week (using ICCS classification: responders, partial responders, non-responders)
Pediatric quality of life
Intervention Details:
Telerehabilitation involved dietary recommendations (e.g., reducing evening fluid intake, avoiding caffeine/chocolate), lifestyle tips, and motivational counseling delivered remotely to caregivers.
Data Analysis:
Pre- and post-intervention outcomes compared using paired t-tests. Demographics and clinical characteristics recorded.
详细描述
Introduction & Background:
Nocturnal Enuresis (NE) is the involuntary urination during sleep in children over 5 years of age, commonly known as bedwetting. It often causes psychological and social distress. Several contributing factors include:
Genetics - Children with a family history are at higher risk.
Bladder dysfunction - Overactive or underactive bladders can contribute.
Hormonal imbalances - Especially a deficiency in antidiuretic hormone (ADH), which leads to excessive nighttime urine production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5 to 10 years.
- •Diagnosed with primary nocturnal enuresis.
- •Experience more than 4 wet nights per week.
- •No prior pharmacological treatment for enuresis.
- •Caregiver is willing to provide informed consent and participate in remote sessions.
排除标准
- •Diagnosis of secondary nocturnal enuresis due to:
- •Neurological disorders
- •Musculoskeletal problems
- •Congenital abnormalities
- •Currently receiving or recently received pharmacological treatment for nocturnal enuresis.
- •Inability to participate in telehealth or remote intervention sessions.
- •Caregiver does not consent to participation.
结局指标
主要结局
number of wet nights/week
时间窗: Baseline and 4 weeks after completion of telerehabilitation intervention
The number of bedwetting episodes recorded by the caregiver during one week.
Pediatric Quality of Life scores
时间窗: Baseline and 4 weeks after completion of telerehabilitation intervention
Child and parent-reported outcomes using the Pediatric Quality of Life Inventory (PedsQL 4.0 Generic Core Scales). This validated tool measures physical, emotional, social, and school functioning. Total score ranges from 0 to 100, where higher scores indicate better quality of life.
次要结局
未报告次要终点
研究者
Mohamed Abdelaziz Emam
Lecturer assistant at of Basic Sciences Department , Faculty of Physical Therapy, Kafrelsheikh Univerisity, Kafrelsheikh 33511, Egypt | PhD Researcher Hungarian University of Sports science, Budapest, Hungary
Kafrelsheikh University