Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Louisiana State University Health Sciences Center in New Orleans
Study ID
NCT06773715
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • KindVR Aqua Program — DEVICE
    For this study, patients will be introduced to a virtual reality software program called Aqua, created by the company KindVR. This software program was designed specifically for use in pediatric patients. The software has been programmed into the Pico Neo 3 headset and provides an immersive 3D experience during which the patients explore a virtual underwater world inside a submarine with a goal of providing more color to treasure and different sea animals that they will engage with along their journey. The VR experience itself lasts approximately 15 minutes

Study Details

The goal of this randomized control clinical trial is to learn if virtual reality can be used to treat sickle cell pain in children. The main questions it aims to answer are: Does virtual reality reduce pain severity during a child's hospital stay for a vaso-occlusive pain crisis? Does virtual reality decrease the daily use of opiates? Researchers will compare standard therapy to the use of standard therapy plus a daily virtual reality experience to see if virtual reality works to treat sickle cell pain. All patients will: \- Be asked to fill out a pain assessment survey three times daily for up to 3 days If randomized to intervention arm, patients will: * Participate in an immersive virtual reality experience once daily for up to 3 days * Fill out a survey twice daily to monitor for side effects from virtual reality experience * Fill out a satisfaction survey once during the study period

Key Dates

Start date
Sep 12, 2024
Status verified
Jan 2025
Primary completion
Dec 19, 2025
Completion
Dec 19, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Controls
    Control patients will continue to receive the standard of care for their vaso-occlusive pain (IV fluid hydration, scheduled IV NSAID, and opiate medication) and have repeat pain assessments at 1 hour and 4 hours from their baseline assessment. This same timeline will occur on days 2 and 3 of admission
  • Experimental: Cases
    In addition to receiving the standard of care for their vaso-occlusive pain, the case patients will have the opportunity to participate in the immersive VR experience after completing their initial pain assessment simulator sickness survey. Following the intervention, their pain levels will be reassessed at the 1-hour and 4-hour mark from their baseline assessment. Additionally, they will be asked to fill out an additional simulator sickness survey upon completion of the VR experience. This same timeline will occur on days 2 and 3 of admission. Prior to discharge or discontinuation from the study, the case patients will be asked to fill out the post-study questionnaire.

Primary Outcome Measure

Pain severity [ Time Frame: From enrollment to the end of hospital admission day 3. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of New OrleansNew OrleansLouisiana70118
Molly E Sonenklar, MD
[email protected]
504-896-9740
Casey M Treuting, MD
[email protected]
504-273-3476
Molly E Sonenklar, MD
Dana M Leblanc, MD
Cori A Morrison, MD
Casey M Treuting, MD

Find similar trials in New Orleans, LA

By condition
Sickle cell disease
By research site
Children's Hospital of New Orleans· New Orleans, LA

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