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Virtual Reality for Mental Health

N/A

Recruiting

Research Sponsored by Thomas Caruso

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1(baseline), day 2

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore whether VR can improve wellbeing in hospitalized kids compared to traditional care.

Who is the study for?

This trial is for pediatric patients aged 5 to 25 at LPCH/SHC facilities looking to improve their self-efficacy in healthcare settings. It's not suitable for those who are pregnant, clinically unstable, non-consenting, use corrective glasses (incompatible with VR), prone to motion sickness or seizures, or currently nauseous.

What is being tested?

The study is testing whether using Virtual Reality (VR) can boost self-confidence in young patients during healthcare compared to the usual care without VR. Participants will be randomly assigned to receive either the standard of care alone or with an additional educational VR experience.

What are the potential side effects?

While there aren't direct side effects from the intervention itself, participants should be aware that using VR could potentially cause temporary discomfort like dizziness or nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1(baseline), day 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1(baseline), day 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1(baseline), day 2 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 educational self efficacy

Secondary study objectives

Change in current mental well being as measured by the modified WHO (Five) Well-Being Index

Change in the caregiver perception of the educational experience of the patient

Change in the intrinsic motivation

+2 more

Other study objectives

Change in the Positive and Negative Affect feeling and emotion for Children

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Virtual Reality then Standard of CareExperimental Treatment2 Interventions

Participants will be randomized to receive the virtual reality intervention on the first day and receive standard of care on the second day of in-patient care.

Group II: Standard of Care then Virtual RealityExperimental Treatment2 Interventions

Participants will be randomized to receive the standard of care on the first day and receive virtual reality intervention on the second day of in-patient care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality

2017

Completed Phase 3

~1580

Standard of Care

2017

Completed Phase 4

~4420