Virtual Reality for Hemophilia

NCT ID: NCT03507582

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-12-28

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.

Conditions

Hemophilia A; Hemophilia B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Distraction

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.

Group Type: ACTIVE_COMPARATOR

Virtual Reality Distraction

Intervention Type: OTHER

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.

Standard of Care Distraction

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Distraction

Intervention Type: OTHER

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.

Interventions

Virtual Reality Distraction

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.

Intervention Type: OTHER

Standard of Care Distraction

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30626567 (View on PubMed)

Other Identifiers

IRB16-00403

Identifier Type: -

Identifier Source: org_study_id