Feasibility and Acceptability of a Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain in Children and Adolescents After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Aim 1: Treatment protocol refinement
研究概览
简要总结
To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.
详细描述
This is a 2-phase study aimed to refine a perioperative treatment protocol for a technology-based intervention (Aim 1) and to understand whether technology-based interventions can be used to help treat pain in children following surgery (Aim 2). Patients will participate in only one phase of the study, and when patients are enrolled will determine what Phase of the study they are in.
In Phase 1, all patients will use the same technology, and no randomization will occur. Primary and secondary outcome measures of Aim 1 are assessed in Phase 1. Actual enrollment for Phase 1 was 23 patients.
In Phase 2, patients will be randomized to receive 1 of 2 technology-based interventions. The perioperative treatment protocol developed in Phase 1 (Aim 1) will be used in Phase 2 to assess the primary and secondary outcome measures of Aim 2. This phase is anticipated to enroll up to 70 participants.
This is not an FDA-regulated drug or device trial as the technology used in this study is categorized as a relaxation device by the FDA and considered "minimal risk", thus exempt from both NDE and IDE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 12 -18 years
- •Scheduled to undergo surgery anticipated to cause moderate to severe pain with expected length of stay > or = to 2 days
- •Able to read, understand and speak English
- •Patients requiring management by the Acute Pain Service
- •Possession of a mobile device/computer available for study participation
排除标准
- •Outside the age range (< 12 or > 18 years)
- •Non-English speaking
- •History of significant developmental delay, uncontrolled psychiatric conditions associated with hallucinations or delusions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
- •History of vertigo, dizziness, seizure disorder, and/or severe motion sickness
- •History of chronic pain
- •Are chronically using opioids and or benzodiazepines for the management of pain
- •Are actively experiencing nausea or vomiting
- •Conditions such as craniofacial abnormalities or surgeries of the head and neck
- •Previous participation in this study
研究组 & 干预措施
Technology Based Intervention 2 (Phase 2)
干预措施: Technology Based Intervention Group 2 (Device)
Technology Based Intervention 1 (Phase 1)
干预措施: Technology Based Intervention Group 1 (Device)
Technology Based Intervention 1 (Phase 2)
干预措施: Technology Based Intervention Group 1 (Device)
结局指标
主要结局
Aim 1: Treatment protocol refinement
时间窗: Duration of study up to 30 days
Frequency of sessions
Aim 2: Feasibility of technology intervention in perioperative patients
时间窗: Pre-intervention
Rate of study recruitment
次要结局
- Aim 1: Preoperative training protocol(Up to two weeks pre-operatively)
- Aim 2: Treatment-specific satisfaction(Post intervention up to two weeks)
- Aim 2: Effect of technology on pain(30 minutes after using technology)
- Aim 2: Rate of study retention(Duration of study up to 30 days)
- Aim 2: Effect of technology on anxiety(Immediately after using technology)
- Aim 1: Post-operative session protocol(Up to two weeks post surgery)
- Aim 2: Rate of study enrollment/randomization(Pre-intervention)
- Aim 2: Rate of treatment adherence(Duration of study up to 30 days)
- Aim 2: Effect of technology on medication use(Duration of hospital stay (2-7 days))
- Aim 2: Self-Reported Outcomes(Day of hospital discharge (Postoperatively 2-7 days))
- Aim 1: Post-operative session protocol(Up to two week post surgery)
- Aim 2: Effect of technology on anxiety(30 minutes after using technology)
- Aim 2: Effect of technology on anxiety(Before using technology)
- Aim 2: Effect of technology on pain(Preoperatively (up to 5 days))
- Aim 2: Effect of technology on pain(Before using technology)
- Aim 2: Effect of technology on pain(Immediately after using technology)
研究者
Vanessa Olbrecht
Chair, Department of Anesthesiology & Perioperative Medicine
Nemours Children's Clinic