Physical and Psychological Measures of Pain in Acute Orthopedic Injuries: Use of At-home Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Client Satisfaction Questionnaire
研究概览
简要总结
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.
详细描述
This study will use mixed-methods to investigate the feasibility of skills-based virtual reality (VR) for acute orthopedic injury in an open pilot with individual exit interviews (target N=10). Participants will be patients with acute orthopedic musculoskeletal injuries who are at risk for chronic pain and disability (PCS ≥ 20 and PASS-20 ≥ 40) and meet inclusionary/exclusionary criteria. Participants will be recruited through the MGH Orthopedics Department, flyers, and the Rally research platform. Participants will self-administer a skills-based virtual reality (VR) program at home over an 8-week period. Participants will attend two in-person study assessments to complete study assessments (surveys and an fNIRS imaging session). The primary outcome for the pilot will be a-priori Go/No-Go feasibility markers (feasibility, acceptability, fidelity, credibility, expectancy, satisfaction) of the VR program and data collection procedures to increase the success of subsequent trials. Exploratory measures include: multi-modal assessment of pain intensity, pain-specific coping (catastrophizing, self-efficacy, acceptance), disability, physical function, and emotional function (depression, anxiety, stress). The VR headset will collect usage data and daily smartphone surveys will track changes in pain during the 8-week intervention. Completers will have the opportunity to attend 30 min individual exit interviews to understand patients' perception of the VR and their experience with the study procedures to increase the success of larger trials.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient adults in the Level 1 Trauma Center
- •Age 18 or older
- •Able to meaningfully participate meaningfully (English fluency and literacy) and stable living situation
- •Acute musculoskeletal injury (e.g., fracture, dislocation, rupture) 1-2 months earlier (acute phase).
- •Pain Catastrophizing Scale ≥20 or Pain Anxiety Symptom Scale-20 ≥40
- •Has access to internet (Wi-Fi or wireless)
- •Willing to participate and comply with the requirements of the study protocol, including virtual reality program and questionnaire completion No psychotropics or stable for >6 weeks
- •Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic medication for a minimum of 6 weeks and willing to maintain a stable dose (i.e., no psychotropics or stable for >6 weeks)
- •Cleared by orthopedic surgeon for study participation
排除标准
- •Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological diseases that are contraindicated for VR
- •Medical condition predisposing to nausea or dizziness.
- •Hypersensitivity to flashing light or motion.
- •Vision or severe hearing impairment.
- •Injury to eyes, face, or neck that impedes comfortable use of virtual reality
- •Diagnosed with a medical illness expected to worsen in the next 3 months (e.g., malignancy)
- •Other serious injuries that occurred with the orthopedic injury or surgical complications (e.g., infection, need for repeat surgery)
- •Current or prior untreated mental illness, substance use disorder, or suicidal ideation
- •Self-reported pregnancy
- •Currently in litigation or under Workman's Comp
- •Practice of cognitive-behavioral therapy, yoga/meditation, or other mind body techniques once per week for 45 minutes or more within the last 3 months
结局指标
主要结局
Client Satisfaction Questionnaire
时间窗: Post-intervention (week 8) only
Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent).
System Usability Scale
时间窗: Post-intervention (week 8) only
Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability. Usability was determined by the number of participants with System Usability Scale scores 68 and above (≥70% good, ≥ 80% excellent).
Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale
时间窗: Pre-intervention (week 0) only
Participants' perceived credibility, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent).
Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale
时间窗: Pre-intervention (week 0) only
Participants' treatment expectancy, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent).
次要结局
- Patient's Global Impression of Change(Post-intervention (week 8) only)
- Feasibility of Enrollment(Throughout the study completion, approximately 1 year)
- Motion Sickness and Nausea(Post-intervention (week 8) only)
- Adherence to Pain Surveys(Pre-intervention (week 0), Post-intervention (week 8))
- Acceptability of Treatment(Pre-intervention (week 0), Post-intervention (week 8))
- Feasibility of Outcome Assessments(Pre-intervention (week 0), Post-intervention (week 8))
研究者
Ryan A., Mace, PHD
Staff Psychologist
Massachusetts General Hospital