Reality PAWS: Examining the Feasibility of a Mixed Reality Dog Visitation Program for Hospitalized Children in Isolation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Electonic Case Report Qualitative Feedback and Observations
研究概览
简要总结
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 支持治疗
- 盲法
- 开放(无盲法)
入排标准
- 年龄范围
- 8 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Children 8 to 21 years old admitted to Children's Hospital Colorado or Children's Hospital Los Angeles
- Children who are English-speaking (legal guardian may be English-speaking or Spanish-speaking)
- Children within the normal range of development will be recruited for this study.
排除标准
- Traumatic brain injury, neurological disorders, neurodevelopmental issues, or other neurological disorders and comorbidities that may confound study outcomes and administration of the study protocol and metrics (e.g., visual field disturbances, frequent nausea/ vomiting, not medically stable, intellectual disability)
- Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
- Children with a history of seizure disorder
- Children currently sick with flu-like symptoms or experiencing a headache or earache
- Children with known or suspected motion sickness
- Children with cochlear implants or pace makers
研究组 & 干预措施
Reality PAWS VR Program Session on Meta Quest 3 VR Device
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.
干预措施: Reality PAWS Program via Meta Quest 3 VR (Device)
结局指标
主要结局
Electonic Case Report Qualitative Feedback and Observations
时间窗: From baseline until study session completion, approximately 30 minutes.
Qualitative self-reported and observed experience on the electronic case report form related to patient's engagement in the MR.
Recruitment Feasibility
时间窗: Through study completion, an average of 6 months.
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.
Intervention Feasibility - Time Spent Using MR
时间窗: From baseline until study session completion, approximately 30 minutes.
Time spent using MR.
Intervention Feasibility - Software
时间窗: From baseline until study session completion, approximately 30 minutes.
Number of technology or software issues.
Measurement Feasibility
时间窗: Through study completion, an average of six months.
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.
Child Simulator Sickness Questionnaire
时间窗: Completed at baseline and again at study session completion, approximately 30 minutes after completing the study intervention MR.
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.
Borg Rating of Perceived Exertion
时间窗: At intervention session completion, approximately 30 minutes after starting the MR intervention.
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.
Gold-Rizzo Immersion and Presence
时间窗: Completed at study session completion, approximately 30 minutes after completing the MR intervention.
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.
Amount of adverse or serious adverse events
时间窗: Until study completion, about 6 months.
Number of adverse and/or serious adverse events.
次要结局
- Faces Anxiety Scale(Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.)
- Faces Pain Scale(Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.)
- Childhood Anxiety Sensitivity Index(Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.)
- Loneliness Visual Analog Scale(Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.)
- Multidimensional State Boredom Scale - Short Form(Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07187245
- 其他研究编号
- 25-1732
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (2个月后)
- 研究完成日期
- (2个月后)
- 最近核实
- (6个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
