Anxiety, Parents, State Anxiety, Trait Anxiety, Virtual Reality
Conditions
Brief summary
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations. The study will be conducted in the general inpatient area, Emergency Department and Heart Center.
Interventions
Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18-99 (Parents whose children is hospitalized) * Able to consent * Parents whose child is undergoing various procedures at LPCH and Stanford Hospital and Clinics.
Exclusion criteria
* People who do not consent * Significant Cognitive Impairment * History of Severe Motion Sickness * Current Nausea * Seizures * Visual Problems * Patients whose children are clinically unstable or require urgent/emergent intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety levels (General inpatient area, Emergency Department) | Baseline, immediately after the intervention | Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels. Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting. |
| State-Trait Anxiety Inventory [Heart Center] | baseline, immediately after the intervention | The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety. Assessed in participants enrolled specifically in the Heart Center. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety levels (Heart Center) | Baseline, immediately after the intervention | Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels. Assessed in participants enrolled specifically in the Heart Center setting. |
| State-Trait Anxiety Inventory (General inpatient area, Emergency Department) | baseline, immediately after the intervention | The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety. Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting. |
| Caregiver Device satisfaction scale (investigator-developed Satisfaction Questionnaire) | immediately after intervention | To evaluate the overall impact of device satisfaction, participants will complete the self-developed satisfaction survey containing 5 items. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = a lot. Assessed in participants enrolled in general hospital setting and specifically in the Emergency Department setting and Heart Center setting. |
| Caregiver-reported acceptability and tolerability of virtual reality (investigator-developed VR Questionnaire) | immediately after virtual reality intervention | Caregiver response to the virtual reality intervention was assessed with an investigator-developed questionnaire administered in English or Spanish after the VR session. Four items assessed relaxation, distraction, willingness to use VR again for a future procedure or hospitalization, and interest in VR; each is scored on a 5-point Likert scale from 1 ("Do not agree at all"/"No interest at all") to 5 ("Completely agree"/"Completely interested"), with higher scores indicating greater acceptability. A final checklist item asked caregivers to indicate whether they experienced any of the following during the virtual reality experience, selecting all that applied: nausea, dizziness, headache, disorientation, eye strain, none of the above, or other. Assessed in participants enrolled in general hospital setting and Heart Center setting. |
Countries
United States
Outcome results
None listed