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Virtual Reality for Hemophilia

NCT03507582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-04-25

No results posted yet for this study

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

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-12-28
Completion
2016-12-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507582 on ClinicalTrials.gov