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

NCT07546305 | Not Yet Recruiting

• 1 other identifier: UoBaghdad_NMohammed_1204b
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Catheterization

Keywords

Virtual Reality; Tablet-Based Distraction; Pediatric Patients; Urinary Catheterization; Behavioral Distress

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (3)

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 to minimize behavioral distress through high-level sensory immersion.

Device: Virtual Reality Distraction

Tablet-Based Distraction Group

Pediatric patients in this group will use a handheld tablet device during the urinary catheterization procedure. They will be allowed to choose between interactive games or animated videos to distract them from the procedure's discomfort.

Device: Tablet-Based Distraction

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.

Other: Standard Nursing Care

Interventions

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.

Virtual Reality Distraction Group

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.

Tablet-Based Distraction Group

Standard Nursing Care OTHER

Routine procedural care including verbal coaching, parental presence, or traditional non-digital distraction methods typically used in the pediatric ward.

Control Group (Standard Care)

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• nibras mohammed kadhim: lead

Study Sites (1)

Welfare Teaching Hospital

Baghdad, Iraq

Location

Related Publications (7)

• Leroy S, et al. Physical and psychological impact of invasive procedures in pediatrics. J Pediatr Nurs. 2020;52:45-52.

  BACKGROUND

• 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.

  BACKGROUND

• Burns-Nader S, Edwards A, Iben S, Jones. Tablet-based distraction in the emergency department. Clin Pediatr. 2021; 60(4): 215-224.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

Central Study Contacts

Nibras Mohammed Kadhim, PHD

CONTACT

9647728580462; nebras.mohammed1204b@conursing.uobaghdad.edu.iq

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)