A Pilot Randomized Controlled Trial to Determine the Feasibility of Administering an auGmented reAlity gaMe to pediatrIc caNcer Patients underGoing Surgery (A GAMING Study)
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of patients who receive the AR game who are able to initiate the game and activate any targets with 1% error rate
研究概览
简要总结
This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking parents/legal guardians and patients
- •Undergoing major surgery for cancer requiring postoperative hospitalization defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
- •Expected to be prescribed postoperative inpatient opioids
- •Have never taken opioids or have had no daily opioid use within the last 30 days
- •Sufficient cognitive capacity to comprehend and interact with the game. This is defined as ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.
- •Both child and a legal guardian are willing and able to provide informed consent.
排除标准
- •History of documented peripheral neuropathy secondary to cancer treatment
- •Inability to demonstrate an understanding of the game from English instructions
- •Have previous played the ARISETM digital scavenger hunt game
- •Any additional concerns based on the study physicians' assessments
研究组 & 干预措施
Non-AR Group
Patients allocated to the control group will be able to interact with the iPad and visualize objects and decals in the walls but not able to initiate the AR technology. In other terms, patients in this group will be provided with the same iPad to the AR group patients with the only exception that the AR technology will be off and will only see objects through the device camera in normal reality.
干预措施: ARISE without AR (Device)
AR Group
Patients randomized to the AR group will be able to use the iPad and SpellBound app to initiate the AR experiences in the game.
干预措施: ARISE with AR (Device)
结局指标
主要结局
Percentage of patients who receive the AR game who are able to initiate the game and activate any targets with 1% error rate
时间窗: The patient's postoperative inpatient hospital stay, average 7 days
Success defined as at least 80% of patients who receive the AR game being able to initiate the game and activate any targets with 1% error rate
次要结局
- Inpatient opioid use(The patient's postoperative inpatient hospital stay, average 7 days)
- Outpatient opioid use(The patient's postoperative inpatient hospital stay, average 7 days)
- Average daily inpatient pain score(The patient's postoperative inpatient hospital stay, average 7 days)
- Number of opioid requests (rescue analgesia)(The patient's postoperative inpatient hospital stay, average 7 days)
- Quality of life assessment(The patient's postoperative inpatient hospital stay, average 7 days)
- Ambulation/ "out of bed" movement(The patient's postoperative inpatient hospital stay, average 7 days)
- Discharge-ready status(The patient's postoperative inpatient hospital stay, average 7 days)
- Patient experience(The patient's postoperative inpatient hospital stay, average 7 days)
- Outpatient pain scores(90 days after the patient is discharged from the hospital)
- Outpatient quality of life(90 days after the patient is discharged from the hospital)