Virtual Reality as an Adjuvant Therapy for Sickle Cell Vaso-Occlusive Crisis in the Pediatric Emergency Department

June 26, 2024 updated by: University of Mississippi Medical Center

Vaso-occlusive crisis (VOC) is the most common complaint in patients with sickle cell disease presenting to the emergency room. VOC is most commonly treated with opioids and NSAIDs. However, new research is demonstrating that opioids in addition to virtual reality (VR) is more effective at reducing the experience of pain and pain nerve signals compared to opioids alone. Numerous research studies have demonstrated that VR reduces the experience of pain during painful medical procedures in children, such as venipuncture and burn wound dressing changes.

The study aims to add VR to standard of care medical treatment for pediatric patients with sickle cell disease who present to the pediatric emergency department in VOC. Investigators will conduct a retrospective chart review of patients aged 6 to 21 years with sickle cell disease who present to the pediatric emergency department with VOC for the historical control arm. Investigators will also conduct a prospective convenient sampling of patient who receive VR plus standard medical care in patients aged 6 to 21years with sickle cell disease who present to the emergency department with VOC. Investigators hypothesize that VR, in addition to standard medical care, will reduce the experience of pain and hospital admissions compared to the historical control group (standard medical treatment).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim 1: To examine the effectiveness of VR plus standard medical therapy in reducing the experience of pain in patients 6 to 21 years with sickle cell VOC who present to the emergency department (ED), compared to historical standard medical care alone. Hypothesis 1: Patients who receive VR in addition to standard medical therapy will report lower pain severity when compared to historical control patients who received standard medical therapy alone.

Aim 2: To examine the effectiveness of VR plus standard medical therapy in reducing hospital admission rates for patients 6 to 21 years with sickle cell VOC who present to the ED, compared to historical standard medical therapy alone. Hypothesis 2: Patients who receive VR in addition to standard medical therapy will have a decreased rate of admission to the hospital compared to historical control patients who received standard medical therapy alone.

Secondary Aim 1: To examine the effectiveness of VR plus standard medical therapy in reducing length of stay in the ED Secondary Hypothesis 1: Patients who receive VR plus standard medical therapy will have shorter stays in the ED when compared to historical control patients who received standard medical therapy alone.

Secondary Aim 2: To examine the effectiveness of VR plus standard medical therapy in reducing time to ED disposition. Secondary Hypothesis 2: Patients who receive VR plus standard medical therapy will have shorter time to ED disposition when compared to historical control patients who received standard medical therapy alone.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age of 6 to 21 years
  2. Sickle cell disease, any genotype
  3. Diagnosis of VOC
  4. Pain score of 4 or greater

Exclusion Criteria:

  1. Non-VOC pain (from acute illness or injury)
  2. Fever
  3. Respiratory distress or acute chest syndrome or cough
  4. Complaints of headache/dizziness/nausea during visit
  5. History of epilepsy or seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
The control arm will be a retrospective chart review of patients ages 6 to 21 who present to the pediatric emergency department with sickle cell VOC listed as one of their diagnoses with the aim of identifying pain scores in accordance with medications received and identifying final disposition and identifying time in the emergency department and time to ED disposition. We aimed to review 100 charts. We found that 84 met inclusion criteria.
Experimental: Trial Arm
The trial arm will be a prospective, convenience sampling of up to 100 patients ages 6 to 21 years who present to the pediatric emergency department with VOC listed as either their main complaint or as one of multiple complaints as identified by health care provider at time of presentation and meet inclusion criteria. The intervention will be virtual reality headset which will be offered simultaneously with standard medication therapy. We actually enrolled 17 patients who met inclusion criteria.
Other: Virtual Reality Goggles
We will offer patients virtual reality goggles with guided meditation software in addition to standard medical therapy (NSAID and opioid).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Disposition
Time Frame: Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.
Patient disposition (admitted to hospital or discharged from emergency department) will be recorded.
Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.
Pain Scores
Time Frame: Pain scores will be measured during patient stay in the ED. This is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 min.
Patient pain scores will be recorded from time of patient presentation, after each dose of pain medication, at time of patient disposition. For the trial arm, pain scores will also be documented before and after the application of virtual reality goggles with guided meditation. Pain scores will be measured with the Wong-Baker Faces Scale generally for children 10 and under or depending on developmental and cognitive ability of the child or on a numeric scale from 0 to 10 with 0 correlating to "no pain" and 10 correlating to "severe pain."
Pain scores will be measured during patient stay in the ED. This is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay in the Emergency Department
Time Frame: Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.
Time from patient arrival in the emergency department to patient leaving the emergency department (either through hospital admission or discharge)
Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.
Time to Emergency Department Disposition
Time Frame: Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.
Time from patient arrival in the emergency department to disposition decision (hospital admission or discharge)
Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Matthew Maready, MD, University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMMC-IRB-2023-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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