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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Catheterization
• Intervention / Treatment: Device: Virtual Reality Distraction; Device: Tablet-Based Distraction

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nibras Mohammed Kadhim, PHD; Phone Number: 9647728580462; Email: nebras.mohammed1204b@conursing.uobaghdad.edu.iq

Study Locations

• Iraq
  • Baghdad, Iraq
    • Welfare Teaching Hospital
    • Contact: Child Protection Teaching Hospital; Phone Number: 9647723499901; Email: nursing@conursing.uobaghdad.edu.iq
    • Contact: Phone Number: 9647513261022

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Study Population

The study population consists of pediatric patients aged 6 to 16 years who are admitted to or visiting the Children's Welfare Teaching Hospital within the Medical City Complex in Baghdad. This population includes children of both genders who are scheduled to undergo a urinary catheterization procedure as part of their clinical care. The participants will be selected from the surgical, urology, or emergency departments where this procedure is commonly performed.

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Virtual Reality Distraction; An immersive VR headset (e.g., Meta Quest or similar) displaying 3D animated content or interactive games specifically designed for pediatric distraction.
Experimental: Tablet-Based Distraction Group; Pediatric patients in this group will use a handheld tablet device during the urinary catheterization procedure.	Device: Tablet-Based 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: nibras mohammed kadhim

Publications and helpful links

General Publications

• Leroy S, et al. Physical and psychological impact of invasive procedures in pediatrics. J Pediatr Nurs. 2020;52:45-52.
• Birnie KA, Ouellette C, Do Amaral T, Stinson JN. Procedural pain management for children: A systematic review and meta-analysis. Pain. 2018;159(11):2112-25.
• Burns-Nader S, Edwards A, Iben S, Jones. Tablet-based distraction in the emergency department. Clin Pediatr. 2021; 60(4): 215-224.
• Gold JI, Mahrer NE. Is virtual reality ready for prime time in the medical setting? A meta-analysis of pediatric pain and distress. J Pediatr Psychol. 2018;43(3):266-80.
• Lambert V, O'Sullivan C, Burke S, O'Toole S. Virtual reality vs tablet-based distraction for pediatric procedural distress: A randomized controlled trial. Pediatr Nurs J. 2024;50(2):112-20.
• Aydin S, Arslan MT. The effect of virtual reality on pain and anxiety during urinary catheterization in children: a randomized controlled study. J Pediatr Urol. 2022;18(5):656.e1-656.e8.
• 1. Hadjiedj S, Annequin D, Gall O. Procedural pain in children: Prevention and treatment. Arch Pediatr. 2021;28(1):70-77. Available from: https://doi.org/10.1016/j.arcped.2020.11.001

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; Urinary Catheterization; Pediatric Patients; Tablet-Based Distraction; Behavioral Distress
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain, Procedural; Anxiety Disorders; Stress, Psychological
• Other Study ID Numbers: UoBaghdad_NMohammed_1204b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect participant privacy. Due to the small sample size and the specific clinical setting (Child Protection Teaching Hospital), there is a risk that participants could be identified even after de-identification. This approach aligns with ethical standards for protecting vulnerable populations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No