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| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
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The goal of this clinical trial is to learn if a mixed reality program, Reality PAWS, delivered on a Meta Quest 3 VR headset, is a feasible intervention for pediatric patients in isolation. It will also evaluate the safety of the program and its effect on pain, anxiety, and loneliness. The main questions the study aims to answer are:
What is the feasibility of utilizing Reality PAWS MR as a substitute for in-person dog therapy for children under isolation precautions? Are patients compliant with using Reality PAWS MR? What are the interventional outcomes of Reality PAWS MR?
Participants will:
Wear a Meta Quest 3 VR headset with the Reality PAWS program. Interact with the program. Answer surveys regarding demographics, anxiety, pain, loneliness, sickness, perceived exertion, and immersion in the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reality PAWS VR Program Session on Meta Quest 3 VR Device | Experimental | Participants will be able to wear a Meta Quest 3 VR Device and interact with the Reality PAWS VR program for up to 30 minutes per session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reality PAWS Program via Meta Quest 3 VR | Device | Reality PAWS is a mixed reality (MR) game that allows patients to interact with a virtual dog. It was developed at Children's Hospital Colorado to serve patients under isolation precautions who are unable to be visited by a facility dog in person. Patients can interact with the game through features such as walking the dog, providing commands, outfitting the dog, giving treats, playing fetch, petting the dog, and playing with others. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility | Number of screened patients, number of eligible patients, number of enrolled patients, number of withdrawn patients, number of subsequent Reality Paws sessions received/requested by patients. | Through study completion, an average of 6 months. |
| Intervention Feasibility - Time Spent Using MR | Time spent using MR. | From baseline until study session completion, approximately 30 minutes. |
| Intervention Feasibility - Software | Number of technology or software issues. | From baseline until study session completion, approximately 30 minutes. |
| Electonic Case Report Qualitative Feedback and Observations | Qualitative self-reported and observed experience on the electronic case report form related to patient's engagement in the MR. | From baseline until study session completion, approximately 30 minutes. |
| Measurement Feasibility | Percent of participants who completed all surveys. This will be determined by taking the number of survey's completed and dividing it by the total number of survey's. | Through study completion, an average of six months. |
| Child Simulator Sickness Questionnaire | Assesses potential side effects of using Reality PAWS, children will provide ratings of simulator sickness using the 7-item Child Simulator Sickness Questionnaire. Consists of items related to potential side effects common to individuals after playing in virtual environments, such as "sickness, headache, and dizziness. The questionnaire asks about symptoms currently experienced as rated on a 0 - 2 scale, with 0 = No, 1 = A little, and 3 = A lot. There are three scoring categories: nausea, oculomotor, and disorientation, with specific questions falling under each category. Each category adds scores of three questions, and a score of three or more indicates simulator sickness. |
| Measure | Description | Time Frame |
|---|---|---|
| Faces Anxiety Scale | Children will be asked to report their anxiety using the Faces Anxiety Scale before and after the MR session. The Faces Anxiety Scale is a single item scale with five possible responses ranging from a neutral face to one showing extreme fear. | Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Not yet recruiting | Los Angeles | California | 90027 | United States |
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| Completed at baseline and again at study session completion, approximately 30 minutes after completing the study intervention MR. |
| Borg Rating of Perceived Exertion | Children will rate their physical exertion after playing Reality PAWS using the Borg Rating of Perceived Exertion. This one-item scale consists of a single question asking children to rate their subjective feeling of exertion, without considering the kinds of physical demands that might lead to this feeling. The scale ranges from 6 (no exertion at all) to 20 (maximal exertion), with higher scores indicating higher levels of perceived exertion. | At intervention session completion, approximately 30 minutes after starting the MR intervention. |
| Gold-Rizzo Immersion and Presence | The Gold-Rizzo Immersion and Presence assesses three domains: sense of involvement, perceived realism, and sense of transportation within the software. The measure contains 16 questions where patients can respond either "no," "a little," or "a lot." Higher total scores indicate a higher level of immersion. | Completed at study session completion, approximately 30 minutes after completing the MR intervention. |
| Amount of adverse or serious adverse events | Number of adverse and/or serious adverse events. | Until study completion, about 6 months. |
| Faces Pain Scale | The Faces Pain Scale - Revised (FPS-R) is a valid and reliable self-report measure where patients see a scale of 6 different faces representing various intensities of pain, ranging from "no pain" to "very much pain." | Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after. |
| Childhood Anxiety Sensitivity Index | A modified version of the Anxiety Sensitivity Index, and is a self-report questionnaire which measures a child's belief that their anxiety will have negative consequences. | Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after. |
| Loneliness Visual Analog Scale | Used to assess loneliness in children via a one-item, self-report, visual analog scale thermometer that includes faces as anchors. The question asks how lonely the child is feeling in the moment, on a rating scale from 0 being not lonely at all, and 10 being extremely lonely. | Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after. |
| Multidimensional State Boredom Scale - Short Form | An eight question scale that is used for brief assessments of boredom. Participants are asked to rank their agreement with the statements using a 7-point Likert scale, 1= Strongly disagree, and 7= Strongly agree, with higher scores indicate higher levels of state boredom. | Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after. |
| Children's Hospital Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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