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Virtual Reality Therapy for Sickle Cell Crisis

N/A
Recruiting
Led By Doralina Anghelescu, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant age must be ≥ 6 years and ≤ 25 years
Participant must have sickle cell disease (any genotype), documented in the St. Jude medical record
Must not have
Inability or unwillingness of research participant or legal guardian/ representative to give written informed consent
Pain in combination with other clinical symptoms that require additional interventions, including fever with focus, acute chest syndrome, acute injury, or splenic sequestration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 30 minutes after intervention
Awards & highlights

Summary

This trial is studying whether virtual reality technology can help reduce pain for people with sickle cell disease who are experiencing an acute pain crisis.

Who is the study for?
This trial is for individuals aged 6-25 with sickle cell disease who are experiencing a severe pain crisis and seeking care at St. Jude Children's Research Hospital. It excludes those with developmental or psychiatric disorders, other acute symptoms, mild pain, or involvement in another pain management trial.
What is being tested?
The study tests if virtual reality therapy can improve pain management during a vaso-occlusive crisis when added to standard treatment. Patients will be randomly assigned to receive either the usual care or usual care plus VR therapy and their pain levels and opioid use will be compared.
What are the potential side effects?
Since this trial involves non-invasive virtual reality technology as an addition to standard care, there may not be direct side effects from the intervention itself; however, discomfort or dizziness related to VR use could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 25 years old.
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I have sickle cell disease, as recorded in my St. Jude medical record.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable or unwilling to give my consent to participate.
Select...
I experience pain along with fever, chest issues, injuries, or spleen problems needing extra care.
Select...
My pain is mild and doesn't require strong painkillers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 30 minutes after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 30 minutes after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in pain scores

Trial Design

2Treatment groups
Active Control
Group I: Standard CareActive Control1 Intervention
Participants receive standard care treatment for their vaso-occlusive crisis. Participants will be randomized by age.
Group II: Virtual RealityActive Control1 Intervention
Participants receive standard care treatment for their vaso-occlusive crisis. In addition, they will have a 15-minute Virtual Reality Therapy session. Participants will be randomized by age.

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
442 Previous Clinical Trials
5,308,793 Total Patients Enrolled
Doralina Anghelescu, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
2 Previous Clinical Trials
141 Total Patients Enrolled
Michael Frett, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT03353584 — N/A
Sickle Cell Disease Research Study Groups: Standard Care, Virtual Reality
Sickle Cell Disease Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT03353584 — N/A
Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT03353584 — N/A
~2 spots leftby Dec 2024
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