Virtual Reality as a Self-Efficacy Intervention

Study Overview
=================
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.

Official Title
-----------------
Improving Self-Efficacy of Hospitalized Children With Virtual Reality Education: A Pragmatic, Crossover Trial

Conditions
-----------------
Psychological

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality
* Behavioral: Standard of Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality then Standard of Care<br>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. | Behavioral: Virtual Reality<br>* During in-patient care participants will be randomized to receive or not receive the educational virtual reality intervention on the first day. After two days, participants will receive a total of 10 minutes interventional in the morning (between 8am to 12pm) every day until their in-patient care concludes.<br>Behavioral: Standard of Care<br>* For case control, participants will service as their self control and be randomized to receive no virtual reality intervention on either the first day or the second day of in-patient care.<br>|
| Experimental: Standard of Care then Virtual Reality<br>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. | Behavioral: Virtual Reality<br>* During in-patient care participants will be randomized to receive or not receive the educational virtual reality intervention on the first day. After two days, participants will receive a total of 10 minutes interventional in the morning (between 8am to 12pm) every day until their in-patient care concludes.<br>Behavioral: Standard of Care<br>* For case control, participants will service as their self control and be randomized to receive no virtual reality intervention on either the first day or the second day of in-patient care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in educational self efficacy | Measured with six items from the modified New General Self-Efficacy Scale. The educational self efficacy is scored on scale ranging from 1 (strongly disagree) to 5 (strongly agree) | Day 1(baseline), Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in current mental well being as measured by the modified WHO (Five) Well-Being Index | The modified WHO (Five) Well-Being Index is a participant-reported outcome measure that assesses current mental well being. Questionnaire contains 5 questions . Scores range from 0 to 5, with higher scores indicating the corresponding feeling exists all the time. | Day 1(baseline), Day 2 | 
| Change in the intrinsic motivation | Measured with six items from the modified Intrinsic Motivation Inventory (IMI) - Interest/Enjoyment Subscale. The perceived interest/enjoyment is scored on scale ranging from 1 (Not at all true) to 7 (very true) | Day 1(baseline), Day 2 | 
| Change in the self-esteem (child) | Measured with five items from the modified Rosenberg Self-Esteem Scale (child). The self-esteem is scored on scale ranging from 1 (very true) to 4 (Definitely not true) | Day 1(baseline), Day 2 | 
| Change in the self-esteem (Adolescent) | Measured with five items from the modified Rosenberg Self-Esteem Scale (Adolescent). The self-esteem is scored on scale ranging from 1 (Strongly agree) to 4 (Strongly disagree) | Day 1(baseline), Day 2 | 
| Change in the caregiver perception of the educational experience of the patient | Measured with seven items from a modified Educational Experience Parental Survey Scale. The caregiver perception of the educational experience of the patient is scored on scale ranging from 1 (strongly disagree) to 7 (strongly agree) | Day 1(baseline), Day 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality