Virtual Reality for Hemophilia
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional

Summary: 
      Children with hemophilia are exposed to intravenous (IV) procedures that cause pain/anxiety
      and distraction methods can be employed to improve the patient experience. Three-dimensional
      virtual reality (VR) environments can reduce distress related to procedures. To be utilized
      in a clinical setting, however, these devices must address infection control concerns and fit
      pediatric patients. Additionally, for use in hemophilia care, environments should encourage a
      subject to keep their hands/arms still to facilitate procedures. Nursing orchestration of the
      VR environment via an iPad dashboard has the potential to increase feasibility and acceptance
      by patients, families and providers of the VR experience without disrupting routine clinical
      care.
    

Detailed description: 
      Patients with hemophilia A and B (HA/HB) are frequently treated with IV infusions of clotting
      factor concentrates to treat and prevent bleeding. Additionally they typically have at least
      yearly IV laboratory assessments. Pain and anxiety with needle related procedures
      particularly in children with hemophilia can lead to development of needle phobia, treatment
      avoidance and poor adherence to treatment regimens. Conventional virtual reality (VR)
      environments have been shown to reduce pain/anxiety in pediatric populations however in a
      clinical setting children with hemophilia have specific VR design needs that have not been
      addressed. Certain issues related to VR environments are related to the pediatric age range.
      These include the size and weight of VR headsets, the ease of donning and doffing headsets,
      and degree of engagement with VR environments. Hemophilia specific issues include the need
      for the VR experience to limit movement of the hands/arms to facilitate IV procedures,
      customization to prevent boredom/disengagement from repeated use and ability of clinical
      staff to trigger events via an orchestration dashboard that occur for the patients benefit at
      key times during IV procedures. Lastly, there are issues related to integration into a
      clinical setting. These include ability to integrate into clinical care without adversely
      affecting clinic flow, and infection control issues related to headset design.
    

Intervention name(s): Virtual Reality Distraction; Standard of Care Distraction
Intervention type(s): Other; Other
Intervention description(s): This intervention consists of a disposable virtual reality headset which will enable the use of virtual reality in clinic through the commodity hardware iPod Touch. An additional piece of software on an iPad will allow clinical staff to act as an orchestrator and trigger events that occur for the patient's benefit in the virtual reality environment. The mechanism for the dashboard will be dashboard software running on an iPad tablet that will wirelessly communicate to the iPod Touch the patient is wearing. A study timer will be incorporated into the orchestration dashboard. The VAS/FACES scale will be incorporated into the iPad used for orchestration.; This intervention consists of a two dimensional distraction (ie TV/tablet) as well as verbal distraction (ie singing/talking/music) will be allowed by caregivers, nurses and phlebotomy staff but will not qualified or quantified. IV procedures will proceed in Groups A and B. At the completion of the IV procedure the nurse orchestrator will stop the procedure timer. The Subject, Guardian and Nurse orchestrator will complete the Final VAS/FACES assessment on the iPad.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other