Virtual Reality Distraction Therapy in Paediatrics
Condition: Child Behavior
Study type: Interventional

Summary: 
      For many children in hospital, having blood tests or cannulation is a significantly
      distressing event physically, psychologically and emotionally. Use of distraction during
      invasive procedures is already common practice in paediatrics to improve the experience both
      for the child and parents. Use of Virtual Reality (VR) and VR Distraction Therapy (VRDT) is a
      relatively new concept, but has already shown promising results in studies.

      "VR offers an interactive distraction technique, a contrast to the passive distraction of
      reading a book or playing games on a tablet … and [VR] is thought to alter pain perception
      and the child's interpretation of pain signals." (Cochrane Library - Virtual reality
      simulation for reducing pain in children).

      The project aims to collect data about venepuncture, cannulation, long lines - qualitative
      and quantitative data - from children and parents. This studyl compares current standard
      practice with VR distraction therapy.
    

Detailed description: 
      Not all studies raise significant issues. Some studies may have straightforward ethical or
      other issues that can be identified and managed routinely. Others may present significant
      issues requiring further consideration by a REC, HRA, or other review body (as appropriate to
      the issue). Studies that present a minimal risk to participants may raise complex
      organisational or legal issues. You should try to consider all the types of issues that the
      different reviewers may need to consider.

      VR companies do not recommend use of their headsets in children under 13 years of age. I do
      not anticipate including 8-12 year olds in the study causing any issues based on experience
      and advice from relevant experts (see below). In summary, the age cut off is borne of lack of
      evidence for long-term effects of VR on visual or brain development, rather than specific
      concerns or evidence existing to inform the age cut off.

      Children's Hospital Colorado (US) use VR in children of 6 years and above. Speaking with
      their Associate Professor of Paediatrics, the age limitation is not derived from medical
      standards or concerns. They discussed with their Neurology department who agreed there is no
      age-specific concern that warrants the 12 year cut-off, and they also rely upon the
      professional expertise of Child Life Specialists who routinely screen toys and devices for
      age-appropriate application. They have used VR in healthcare for children several hundred
      times and have no concerns about the age cut off the VR companies suggest.

      Stanford University School of Medicine (US) run the highest volume clinical VR therapy
      program in the US, with thousands of children each year receiving VR. Their department
      similarly does not exclude under 13 year olds from their program.

      Clinicians experienced with VR in the UK have spoken to VR companies involved in their
      studies, and the information gives was that there no long-term data on VR and its effects on
      brain and visual development. These clinicians also use VR on children aged 5-6 years and
      above.

      I have met with the VR company Dubit Limited, which shows in its global trends data that
      children much younger than 13 are already using VR. The publication "Children and Virtual
      Reality: Emerging Possibilities and Challenges" contains data from studies looking at the
      8-12 year old age group; there is not any current evidence of adverse events in this age
      group, though transient change to visual function has been seen only in a minority of VR
      users in this age group.
    

Intervention name(s): Application of a virtual reality headset
Intervention type(s): Behavioral
Intervention description(s): Use of a headset to experience a different reality
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic