Recruiting

Virtual Reality

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT06773715

Conditions

Sickle Cell Disease

Vaso-occlusive Pain Episodes

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

Interventions

KindVR Aqua Program

Study Details

Brief 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

Conditions

Sickle Cell Disease

Vaso-occlusive Pain Episodes

Study ID

NCT06773715

Start date

Sep 12, 2024

Status verified date

Jan, 2025

Completion date

Dec 19, 2025

Anticipated

Primary completion date

Dec 19, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient ≥ 8 up to 21 years of age
2. Presenting to CHNOLA ER or outside facility with chief complaint of vaso-occlusive pain crisis, requiring inpatient admission for further pain management
3. No known cognitive or neurological deficits
4. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Patients aged 7-years-old and younger.
2. 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
3. Patients who are developmentally or cognitively incapable of using VR equipment and answering questions appropriately
4. Failure to obtain or refusal to provide parental/guardian permission (informed consent) and if appropriate child assent
5. Patient has previously participated in the study
6. Study team is unable to initiate study interventions within the first 24 hours of a patient's admission

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

KindVR Aqua Program

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Molly E Sonenklar, MD

504-896-9740msonen@lsuhsc.edu

Casey M Treuting, MD

504-273-3476ctreu1@lsuhsc.edu

Locations

Children's Hospital of New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Molly E Sonenklar, MD

504-896-9740msonen@lsuhsc.edu

Casey M Treuting, MD

504-273-3476ctreu1@lsuhsc.edu

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

Jan 14, 2025

Last verified

Jan, 2025

Keywords

  • virtual reality
  • adjunctive therapy
  • opiate consumption
  • pain reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2025-01-14.