Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain

NCT06773715 | Recruiting

• 1 other identifier: IRB# 7634
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

virtual reality; adjunctive therapy; opiate consumption; pain reduction

Outcome Measures

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.

  From enrollment to the end of hospital admission day 3.

Secondary Outcomes (3)

• Opiate Consumption

  From enrollment to the end of hospital admission day 3.

• Hospital Length of Stay.

  From enrollment to hospital discharge (an average of 5 days)

• Patient Satisfaction (for case patients only)

  Once, on day 2 or day 3 of enrollment

Study Arms (2)

Controls

NO INTERVENTION

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

Cases

EXPERIMENTAL

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.

Device: KindVR Aqua Program

Interventions

KindVR Aqua Program DEVICE

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

Cases

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patient has previously participated in the study
• Study team is unable to initiate study interventions within the first 24 hours of a patient's admission

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• KindVR: collaborator

Study Sites (1)

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

RECRUITING

Related Publications (5)

• Litwin SP, Nguyen C, Hundert A, Stuart S, Liu D, Maguire B, Matava C, Stinson J. Virtual Reality to Reduce Procedural Pain During IV Insertion in the Pediatric Emergency Department: A Pilot Randomized Controlled Trial. Clin J Pain. 2021 Feb 1;37(2):94-101. doi: 10.1097/AJP.0000000000000894.

  PMID: 33177370 BACKGROUND

• Fernandes AM, De Campos C, Batalha L, Perdigao A, Jacob E. Pain assessment using the adolescent pediatric pain tool: a systematic review. Pain Res Manag. 2014 Jul-Aug;19(4):212-8. doi: 10.1155/2014/979416. Epub 2014 Jun 20.

  PMID: 24950413 BACKGROUND

• Birnie KA, Kulandaivelu Y, Jibb L, Hroch P, Positano K, Robertson S, Campbell F, Abla O, Stinson J. Usability Testing of an Interactive Virtual Reality Distraction Intervention to Reduce Procedural Pain in Children and Adolescents With Cancer [Formula: see text]. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):406-416. doi: 10.1177/1043454218782138. Epub 2018 Jun 27.

  PMID: 29950139 BACKGROUND

• Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.

  PMID: 15745448 BACKGROUND

• Agrawal AK, Robertson S, Litwin L, Tringale E, Treadwell M, Hoppe C, Marsh A. Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. Pediatr Blood Cancer. 2019 Feb;66(2):e27525. doi: 10.1002/pbc.27525. Epub 2018 Oct 26.

  PMID: 30362236 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Molly E Sonenklar, MD

CONTACT

504-896-9740; msonen@lsuhsc.edu

Casey M Treuting, MD

CONTACT

504-273-3476; ctreu1@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Pediatrics

Model Details: Randomized Controlled Study * Control patients will receive standard of care therapy for their vaso-occlusive pain crisis * Case patients will receive standard of care therapy PLUS VR experience for their vaso-occlusive pain crisis * Patients will be randomly assigned into the case or control group based off a random number system that will assign N/2 patients into each group. The statistician included on this project will generate the random numbers prior to the enrollment of the first patient onto the study. * To ensure equality between case and control groups, block stratification based on age and gender will be utilized at the time of data analysis

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: January 14, 2025
• Study Start: September 12, 2024
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)