Effect of Virtual Reality and Tablet-Based Distraction Techniques on Behavioral Distress in Children During Urinary Catheterization

ConditionUrinary Catheterization

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-16

Sponsornibras mohammed kadhim

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Virtual Reality Distraction
Device
An immersive VR headset (e.g., Meta Quest or similar) displaying 3D animated content or interactive games specifically designed for pediatric distraction.
Tablet-Based Distraction
Device
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.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Virtual Reality Distraction GroupExperimental treatment 1 intervention

Group B: Tablet-Based Distraction GroupExperimental treatment 1 intervention

Group C: Control Group (Standard Care)No intervention 0 interventions

Trial outcomes

Primary outcomes

Children's Behavioral Distress Level

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

Time frame

Measurements recorded at three points: 2 minutes before (Baseline), during the procedure (2-5 minutes), and 2 minutes after completion (Recovery).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

nibras mohammed kadhim

Lead sponsor

University of Baghdad

Sponsor institution

Source ClinicalTrials.gov

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