Feasibility of a Dual English/Spanish Mobile Augmented Reality Pain Assessment App to Reduce Postoperative Prescription Opioid Use in Hispanic/Latino Pediatric and Adolescent Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Primary; Percent of enrolled patients who activated/used the app during the PACU stay
研究概览
简要总结
In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 7-17 years old
- •child able to provide assent, and a legal guardian able to provide informed consent
- •current diagnosis of pediatric cancer
- •undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization
- •prescribed or expected to be prescribed opioids during inpatient perioperative period
- •sufficient mental capacity to comprehend and interact with the game in English or Spanish.
排除标准
- •the inability to play with the SpellBound app from English or Spanish instructions
- •daily opioid use within 30 days prior to surgery
- •any concerns from the treatment team.
结局指标
主要结局
Primary; Percent of enrolled patients who activated/used the app during the PACU stay
时间窗: immediately after the intervention/procedure/surgery
Feasibility measured as activation/usage of the app recorded by the device ID for each patient
次要结局
- Total time spent playing on the AR app during the PACU stay(immediately after the intervention/procedure/surgery)
- Recorded responses about pain assessment from the app(immediately after the intervention/procedure/surgery)
- Recorded responses about nausea/vomit assessment from the app(immediately after the intervention/procedure/surgery)
- Inpatient opioid consumption(immediately after the intervention/procedure/surgery)
- Length of stay(immediately after the intervention/procedure/surgery)
- Quality of life survey(immediately after the intervention/procedure/surgery)
- Rate of opioid prescription(immediately after the intervention/procedure/surgery)
- Patient/caregiver satisfaction survey(immediately after the intervention/procedure/surgery)