Effect of Virtual Reality and Tablet-Based Distraction Techniques on Behavioral Distress in Children During Urinary Catheterization: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Children's Behavioral Distress Level
研究概览
简要总结
This randomized controlled trial will evaluate the effect of Virtual Reality (VR) and tablet-based distraction techniques on children's behavioral distress during urinary catheterization, compared with a control group receiving standard care. Urinary catheterization is a painful and distressing procedure for children that requires effective non-pharmacological interventions to manage anxiety and pain. Participants will be randomly assigned to one of three groups: VR distraction, tablet-based distraction, or control. The findings of this study will provide evidence on the effectiveness of digital distraction methods in reducing behavioral distress and improving the overall experience for pediatric patients undergoing invasive procedures at specialized pediatric centers.
详细描述
Urinary catheterization is a common yet highly stressful medical procedure in pediatric settings, often leading to significant behavioral distress, anxiety, and pain. High levels of distress can complicate the procedure and lead to negative psychological outcomes for the child. While traditional distraction methods exist, advanced technological approaches such as Virtual Reality (VR) and tablet-based games are gaining attention; however, more comparative evidence is needed regarding their efficacy during specific invasive procedures like catheterization.
This study will be conducted as a randomized controlled trial at the Children's Welfare Teaching Hospital within the Medical City Complex in Baghdad. A total of [Insert Number] children requiring urinary catheterization will be enrolled and randomly assigned to one of three groups:
Virtual Reality (VR) Group: Children will engage with immersive VR content using a headset during the procedure to provide a high level of sensory immersion.
Tablet-Based Group: Children will use interactive games or videos on a handheld tablet, representing a more common digital distraction tool.
Control Group: Children will receive routine procedural care or standard distraction as per the hospital's current protocols.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Children aged 6 to 16 years.
- •Procedure: Children undergoing urinary catheterization at the Children's Welfare Teaching Hospital.
- •Cognitive Status: Children with normal cognitive development and the ability to follow instructions.
- •Sensory Ability: Children with normal or corrected-to-normal vision and hearing.
- •Consent: Obtaining written informed consent from the legal guardian and verbal assent from the child.
排除标准
- •Medical History: History of epilepsy, seizures, or severe motion sickness (VR safety).
- •Emergency Cases: Children requiring urgent/emergency catheterization.
- •Disabilities: Children with intellectual disabilities or significant physical impairments.
研究组 & 干预措施
Virtual Reality Distraction Group
Pediatric patients in this group will be provided with a Virtual Reality (VR) headset during the urinary catheterization procedure. They will engage with immersive, age-appropriate 3D content during procedure
干预措施: Virtual Reality Distraction (Device)
Tablet-Based Distraction Group
Pediatric patients in this group will use a handheld tablet device during the urinary catheterization procedure.
干预措施: Tablet-Based Distraction (Device)
Control Group (Standard Care)
Pediatric patients in this group will receive the standard nursing care and routine distraction protocols currently implemented at the Children's Welfare Teaching Hospital. No digital devices (VR or Tablets) will be introduced.
干预措施: Standard Nursing Care (Other)
结局指标
主要结局
Children's Behavioral Distress Level
时间窗: Measurements recorded at three points: 2 minutes before (Baseline), during the procedure (2-5 minutes), and 2 minutes after completion (Recovery).
Behavioral distress will be assessed using the Observational Scale of Behavioral Distress-Revised (OSBD-R), specifically focusing on 8 key behavioral categories (such as crying, screaming, physical restraint, and verbal resistance). Each behavior is weighted based on its intensity to provide a comprehensive distress score. Data will be collected across three procedural phases to evaluate the effectiveness of Virtual Reality and Tablet-based distraction compared to standard care. Lower total scores indicate a reduction in behavioral distress
次要结局
未报告次要终点
研究者
nibras mohammed kadhim
Lecturer
University of Baghdad