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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

No Placebo-Only Group

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.

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I experience pain along with fever, chest issues, injuries, or spleen problems needing extra care.

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My pain is mild and doesn't require strong painkillers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and up to 30 minutes after intervention

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met