Welfare Teaching Hospital
Baghdad, Iraq
NCT Number: NCT07546305
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.
Trial opening soon.
Get Notified6 year–16 year
All sexes
Interventional
Not applicable
Baghdad, Iraq
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.
Data will be collected using standardized tools to measure behavioral distress, such as the Observational Scale of Behavioral Distress-Revised (OSBD-R). The study will compare the effects of these distraction methods on the level of distress exhibited by the children before, during, and after the procedure. Additionally, the study aims to provide clinical evidence that can be integrated into nursing practice at the Children's Welfare Teaching Hospital to enhance the quality of pediatric nursing care and reduce the psychological impact of invasive procedures.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An immersive VR headset (e.g., Meta Quest or similar) displaying 3D animated content or interactive games specifically designed for pediatric distraction.
A handheld tablet device (e.g., iPad or Android Tablet) providing two-dimensional interactive games or animated videos selected according to the child's preference.
Time frame: 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
Contact information is provided by the study sponsor or research team.
nibras mohammed kadhim
Other
Effect of Virtual Reality and Tablet-Based Distraction Techniques on Behavioral Distress in Children During Urinary Catheterization: A Randomized Controlled Trial
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