Clinical trial NCT05725395: Virtual Reality as a Self-Efficacy Intervention
Official title: Improving Self-Efficacy of Hospitalized Children With Virtual Reality Education: A Pragmatic, Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological
Keywords: Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal is to explore the use of Virtual Reality (VR) as an intervention to increase self-efficacy in a healthcare setting. The investigators would like to determine if an educational VR intervention in the course of healthcare could increase pediatric patient self-efficacy compared to standard of care (i.e no VR).

Detailed description: While virtual reality has gained momentum as a therapeutic supplement to distract from pain perception and to reduce anxiety, it has received less attention as an intervention to promote more holistic psychological self-efficacy in the course of in-patient care. Child and adolescent self-reported measures of self-efficacy have also been looked over in favor of parent or practitioner measures of a child's self-efficacy.

To evaluate the effectiveness of virtual reality on child and adolescent self-efficacy while undergoing hospital care, the investigators will determine the effect of virtual reality to 1) increase pediatric patient self-efficacy compared to standard of care using educational virtual reality, 2) establish a comprehensive profile of short-term psychological well-being in school-aged children and adolescents following admission to a hospital. Participants will serve as their own control to either receive intervention on the first day or second day of the in-patient care and no intervention will be given on the other day.

Eligibility criteria: Inclusion Criteria:

* Patients' age range from 5 to 25 at LPCH/SHC facilities

Exclusion Criteria:

* Participants who do not consent
* Have a history of seizure disorder
* Currently have nausea
* Have motion sickness
* Are clinically unstable
* Currently using corrective glasses (not compatible with VR headset)
* Currently pregnant

Primary outcomes:
measure: Change in the intrinsic motivation
timeFrame: Day 1(baseline), Day 2
Secondary outcomes:
measure: Change in current mental well being as measured by the modified WHO (Five) Well-Being Index
timeFrame: Day 1(baseline), Day 2
measure: Change in the self-esteem (child)
timeFrame: Day 1(baseline), Day 2
measure: Change in the self-esteem (Adolescent)
timeFrame: Day 1(baseline), Day 2
measure: Change in the caregiver perception of the educational experience of the patient
timeFrame: Day 1(baseline), Day 2
measure: Change in educational self efficacy
timeFrame: Day 1(baseline), Day 2
Other outcomes:
measure: Change in the Positive and Negative Affect feeling and emotion for Children
timeFrame: Day 1(baseline), Day 2
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
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