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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Children's Behavioral Distress Level [Срок оценки: Measurements recorded at three points: 2 minutes before (Baseline), during the procedure (2-5 minutes), and 2 minutes after completion (Recovery).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Ирак · 1 центр

• Welfare Teaching Hospital — Baghdad

Публикации

• 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 Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129. PMID 29053848
• 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

Идентификаторы

NCT: NCT07546305 · UoBaghdad_NMohammed_1204b

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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