Flexible Attention Sensory Training for Youth with Chronic Pain: a Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Acceptability of the Intervention- Theoretical framework of acceptability (TFA) Questionnaire
研究概览
简要总结
The purpose of this study is to determine the feasibility and acceptability of gamified sensory rehabilitation training technology for children with chronic musculoskeletal pain.
详细描述
The TrainPain devices allows patients with chronic pain to perform sensory rehabilitation training at home, in a gamified format. The system uses a temporary tactile discrimination task, which directly engages inhibitory functions of the somatosensory cortex. In this way, the game trains the brain's sensory system to be more precise. The technology's dual-probe system allows sensory stimuli to be delivered to multiple body locations, which trains patients to flexibly shift their attention towards and away from pain according to dynamic game-directed goals. The sensory training reduces hypervigilance towards painful body regions and enables flexible attention shifting to engage with daily goals. Last, the TrainPain system captures and quantifies performance over time, providing a breadth of intricate and precise data, thus allowing the research team to assess outcomes and mechanisms of training effects. In preliminary studies with adults, TrainPain is shown to be highly engaging, and effective at reducing pain in adults with widespread musculoskeletal (MSK) pain. The current pilot study intends to establish, for the first time, the feasibility and acceptability of using the TrainPain system among youth with chronic MSK pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of musculoskeletal pain including chronic regional pain syndrome
- •English speaking
排除标准
- •Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay
- •Severe affect disorders (e.g. severe depression/anxiety) from medical record review
- •Chronic skin disease or topical allergies that would be worsened by the use of sensor tape
结局指标
主要结局
Acceptability of the Intervention- Theoretical framework of acceptability (TFA) Questionnaire
时间窗: Discharge (at 8 weeks)
Acceptability will also be assessed quantitatively at the end of treatment through a brief survey related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Survey responses will be reported categorically. Responses are measured using a five-point Likert scale from 'Strongly disagree' to 'Strongly agree' with higher scores indicating greater acceptability.
Feasibility of the Intervention- Usage Metrics
时间窗: Baseline through discharge (at 8 weeks)
Engagement will be assessed via collected use metrics (e.g. how long the app was played each day).
Acceptability of the Intervention- Net Promoter Score
时间窗: Discharge (at 8 weeks)
Acceptability will be evaluated by examining mean promoter score (measured on 10-point Likert scale) post intervention. Range 0-10 (higher scores indicate more acceptability). Questionnaire will be administered to youth with chronic pain.
Acceptability of the Intervention- Qualitative Interview
时间窗: Discharge (at 8 weeks)
Acceptability will also be assessed qualitatively at the end of treatment through interview questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Survey responses will be reported categorically. Qualitative responses will be described and summarized.
次要结局
- Brief Pain Inventory Short Form (BPI)(Baseline through discharge (at 8 weeks) weekly and follow up (1-month))
- Bodily Threat Monitoring Scale (BTMS)(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Patient Global Impression of Change (PGIC) Scale(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Pain Vigilance and Awareness Questionnaire (PVAQ)(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Child Pain Acceptance Questionnaire (CPAQ)(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Multidimensional Assessment of Interoceptive Awareness Youth (MAIA-Y)(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Revised Life Orientation Test (LOT-R)(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Childrens Hope Scale (CHS)(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Pain Catastrophizing Scale (PCS-C)(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Weekly Diary(Treatment (weekly for 8 weeks))
- Parent Psychological Flexibility Questionnaire (PPF-P)(Baseline, discharge (at 8 weeks), and follow up (1-month))
- Pain Catastrophizing Scale (PCS-P)(Baseline, discharge (at 8 weeks), and follow up (1-month))
研究者
Laura E Simons
Professor of Anesthesiology, Perioperative and Pain Medicine
Stanford University