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Virtual Reality Therapy for Sickle Cell Crisis

N/A
Recruiting
Led By Michael Frett, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 30 minutes after intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
428 Previous Clinical Trials
5,306,537 Total Patients Enrolled
Michael Frett, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
Doralina Anghelescu, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
2 Previous Clinical Trials
141 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers recruiting study participants at this time?

"According to clinicaltrials.gov, this research study is actively seeking participants; the initial post date was February 5th 2018 and it has been modified as recently as November 17th 2022."

Answered by AI

Does this clinical trial have an age requirement, and if so, is it accommodating those over 40?

"This trial is available to individuals aged 6-25. There are 132 trials for minors and 86 clinical studies for seniors over the age of 65."

Answered by AI

Do I fulfill the requirements to partake in this medical experiment?

"The parameters for inclusion in this trial necessitate that participants must have anemia and sickle cell, additionally they need to be between 6-25 years old. 76 individuals are being sought after by the clinical team."

Answered by AI

How many participants are being evaluated in this research project?

"Affirmative. Clinicaltrials.gov data demonstrates that this research endeavour, which was initially publicized on February 5th 2018, is currently in search of volunteers. About 76 participants are needed from one medical centre."

Answered by AI
~7 spots leftby Dec 2024