Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-21
SponsorLouisiana State University Health Sciences Center in New Orleans
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
KindVR Aqua Program
DeviceFor 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
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: ControlsNo intervention 0 interventions
Group B: CasesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain severity
The Adolescent-Pediatric Pain Tool is a well validated, multidimensional pain assessment tool designed to evaluate the location, severity, and quality of pain in pediatric patients. It is comprised of three independent parts, one which is a 10 cm line anchored from 0 to10, with zero being equivalent to "no pain" and 10 being equivalent to "worst pain possible". This data point will be collected up to 9 times for each participant in this study. The trends will be compared amongst the control and case groups.
Time frame
From enrollment to the end of hospital admission day 3.Secondary outcomes
1
Opiate Consumption
Goal is to assess virtual reality's ability to decrease a patient's total opiate consumption during their inpatient admission. Equivalent opiate dosing per day, measured in oral morphine equivalents/kg/day for each participant.
Time frame
From enrollment to the end of hospital admission day 3.2
Hospital Length of Stay.
Assessing whether the use of virtual reality for a patient's vaso-occlusive pain crisis can reduce their length of stay in the hospital. Measured in number of days.
Time frame
From enrollment to hospital discharge (an average of 5 days)3
Patient Satisfaction (for case patients only)
The study will evaluate whether the use of virtual reality's ability to improve patient satisfaction for their hospital admission. This will be measured via the use of the Post-Study Questionnaire, a 16-question survey provided by the KindVR company. It will be used to assess the patient's satisfaction of the Aqua program, the comfort of the equipment, and future guidance to aid quality improvement.
Time frame
Once, on day 2 or day 3 of enrollmentSponsors and contacts
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Source ClinicalTrials.gov