Changing the View of Pain: Using Virtual Reality As Adjunctive Therapy for Sickle Cell Pain in Pediatric Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
United States
Louisiana
Children's Hospital of New Orleans
RECRUITING
New Orleans
Contact Information
Primary
Molly E Sonenklar, MD
msonen@lsuhsc.edu
504-896-9740
Backup
Casey M Treuting, MD
ctreu1@lsuhsc.edu
504-273-3476
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2025-12-19
Participants
Target number of participants: 36
Treatments
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.
Sponsors
Leads: Louisiana State University Health Sciences Center in New Orleans
Collaborators: KindVR

This content was sourced from clinicaltrials.gov