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NCT Number: NCT07546305

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

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.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Children's Behavioral Distress Level

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nibras Mohammed Kadhim, PHD

CONTACT

[email protected]

9647728580462

Sponsors and collaborators

Lead sponsor

nibras mohammed kadhim

Other

Registry information

Official study title

Effect of Virtual Reality and Tablet-Based Distraction Techniques on Behavioral Distress in Children During Urinary Catheterization: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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