Actively Recruiting

Phase Not Applicable
Age: 8Years - 21Years
All Genders
ID06773715

Using Virtual Reality as Additional Therapy for Sickle Cell Vaso-Occlusive Pain in Children and Young Adults A Randomized Clinical Trial

Led by Louisiana State University Health Sciences Center in New Orleans · Updated on 2025-01-14

36

Participants Needed

1

Research Sites

66 weeks

Total Duration

On this page

Sponsors

L

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

K

KindVR

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating if virtual reality can help reduce pain severity and opioid use in children hospitalized for sickle cell vaso-occlusive pain crises. This study compares standard care alone to standard care plus a daily virtual reality experience to see if the immersive technology can complement pain management and improve patient satisfaction. The trial focuses on pediatric patients admitted for sickle cell pain episodes, recognizing the complexity and individual nature of pain and the need for multidisciplinary approaches beyond opioid therapy. Participants may receive standard therapy or standard therapy combined with a daily virtual reality session using the KindVR Aqua program. This program provides a 15-minute immersive underwater exploration via a Pico Neo 3 headset, designed specifically for children. The study lasts up to 3 days during hospital admission, with the intervention delivered once daily alongside routine pain management. All patients complete pain assessments three times daily during their hospital stay. Those using virtual reality will also complete surveys twice daily to monitor for side effects and a satisfaction survey once during the study. Pain severity is tracked from enrollment through hospital day 3. There is no follow-up period after hospital discharge, and all study activities occur during the inpatient admission.

CONDITIONS

Official Title

Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain

Who Can Participate

Age: 8Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 8 up to 21 years of age
  • Presenting with vaso-occlusive pain crisis requiring hospital admission for pain management
  • No known cognitive or neurological deficits
  • Parental or guardian permission and child assent if appropriate
Not Eligible

You will not qualify if you...

  • Patients 7 years old or younger
  • Presence of sickle cell complications requiring more than standard vaso-occlusive pain care, such as acute chest syndrome, splenic sequestration, post-operative pain, or stroke
  • Developmental or cognitive inability to use virtual reality equipment or answer questions
  • Lack of parental or guardian permission or refusal of child assent
  • Prior participation in this study
  • Inability to start study interventions within 24 hours of hospital admission

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital of New Orleans

New Orleans, Louisiana, United States, 70118

Actively Recruiting

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Research Team

M

Molly E Sonenklar, MD

C

Casey M Treuting, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Virtual Reality to Reduce Procedural Pain During IV Insertion in the Pediatric Emergency Department: A Pilot Randomized Controlled Trial.

Sasha P Litwin, Cynthia Nguyen, Amos Hundert...

https://pubmed.ncbi.nlm.nih.gov/33177370

Usability Testing of an Interactive Virtual Reality Distraction Intervention to Reduce Procedural Pain in Children and Adolescents With Cancer [Formula: see text].

Kathryn A Birnie, Yalinie Kulandaivelu, Lindsay Jibb...

https://pubmed.ncbi.nlm.nih.gov/29950139

The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556].

Debashish A Das, Karen A Grimmer, Anthony L Sparnon...

https://pubmed.ncbi.nlm.nih.gov/15745448