Virtual Reality for Hemophilia

NCT03507582 | Completed

• 1 other identifier: IRB16-00403
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A; Hemophilia B

Outcome Measures

Primary Outcomes (2)

• Nurse Orchestrated Virtual Reality Distraction

  The primary outcome of feasibility was assessed using a surrogate marker of feasibility which was duration of the IV procedure measured in minutes in both study arms. Procedure time was the length of time from the moment a patient was positioned for the procedure to the completion of the procedure. The study timer was incorporated in the study IPAD and timing was performed by the nurse orchestrator.

  Twelve months

• Standard of Care Distraction

  The primary outcome of feasibility was assessed using a surrogate marker of feasibility which was duration of the IV procedure measured in minutes in both study arms. Procedure time was the length of time from the moment a patient was positioned for the procedure to the completion of the procedure. The study timer was incorporated in the study IPAD and timing was performed by the nurse orchestrator.

  Twelve months

Secondary Outcomes (2)

• Effectiveness of the distraction technique

  Twelve months

• Usability and Likeability

  Twelve months

Study Arms (2)

Virtual Reality Distraction

ACTIVE COMPARATOR

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.

Other: Virtual Reality Distraction

Standard of Care Distraction

ACTIVE COMPARATOR

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.

Other: Standard of Care Distraction

Interventions

Virtual Reality Distraction 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.

Virtual Reality Distraction

Standard of Care Distraction 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.

Standard of Care Distraction

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 30626567 DERIVED

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 25, 2018
• Study Start: April 1, 2016
• Primary Completion: December 28, 2016
• Study Completion: December 28, 2016
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (1)