Clinical trial NCT03507582: Virtual Reality for Hemophilia
Official title: A Feasibility and Usability Study of a Nursing Orchestrated, Customized 3 Dimensional Virtual Reality Environment in Children With Hemophilia Undergoing Routine Intravenous Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Hemophilia B
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Provide signed and dated informed consent form
2. Willing to comply with all study procedures and be available for the duration of the study
3. Diagnosed with Hemophilia A or B
4. Male or female, aged \>6 years to \<19 years
5. Subject and caregiver able to understand and speak English
6. Being seen for routine comprehensive hemophilia care visits during which an IV procedure is planned as standard of care.

Exclusion Criteria:

1. Inability to use the VR equipment (ie visual, cognitive or hearing impairment that would preclude engagement with the VR environment)
2. History of motion sickness as reported by patient or caregiver
3. History of poorly controlled seizures as reported by patient or caregiver

Primary outcomes:
measure: Nurse Orchestrated Virtual Reality Distraction
timeFrame: Twelve months
measure: Standard of Care Distraction
timeFrame: Twelve months
Secondary outcomes:
measure: Effectiveness of the distraction technique
timeFrame: Twelve months
measure: Usability and Likeability
timeFrame: Twelve months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Dunn A, Patterson J, Biega CF, Grishchenko A, Luna J, Stanek JR, Strouse R. A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial. JMIR Serious Games. 2019 Jan 9;7(1):e10902. doi: 10.2196/10902.