Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain (NCT06773715) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain
United States36 participantsStarted 2024-09-12
Plain-language summary
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
Who can participate
Age range8 Years – 21 Years
SexALL
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Inclusion criteria
✓. Patient ≥ 8 up to 21 years of age
✓. Presenting to CHNOLA ER or outside facility with chief complaint of vaso-occlusive pain crisis, requiring inpatient admission for further pain management
✓. No known cognitive or neurological deficits
✓. Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion criteria
✕. Patients aged 7-years-old and younger.
✕. Patents upon admission found to have sequela of their sickle cell disease that would require medical therapy greater than the standard of care for a vaso-occlusive pain event. This includes acute chest syndrome, splenic sequestration, post-operative pain, and/or cerebrovascular accident
✕. Patients who are developmentally or cognitively incapable of using VR equipment and answering questions appropriately
✕. Failure to obtain or refusal to provide parental/guardian permission (informed consent) and if appropriate child assent
What they're measuring
1
Pain severity
Timeframe: From enrollment to the end of hospital admission day 3.
Trial details
NCT IDNCT06773715
SponsorLouisiana State University Health Sciences Center in New Orleans