Adjunct VR Pain Management in Acute Brain Injury
关键词
抽象
描述
Each participant will undergo one VR session and two control sessions. The VR session will take place in a VR environment developed in our own Shock Trauma Blended Reality Center and last 20-30 minutes. The environment is based upon literature reviews on chromotherapy. The control sessions will include a 2D-tablet based session that mimics the VR content and a content-less placement of the VR headset. The order of these sessions will be randomized across patients.
Each participant will complete a pre-study questionnaire to elicit their prior experience with the virtual reality as well as measures of gaming addiction/engagement, boredom, and expectancy. These scales will help us determine which patient-level factors predict response to VR. Before and after each session, participants will complete validated scales of pain, nausea, and anxiety.. Pre- and Post-VR opioid use will be recorded. Basic vital signs including heart rate, blood pressure, and respiratory rate, will be recorded before and after each session to monitor autonomic response. Advanced measures of autonomic response will include heart rate variability, galvanic skin response, and pupillometry metrics. At the conclusion of all sessions, participants will complete another questionnaire to document their subjective experience of using VR.
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 04/18/2020 |
| 提交的预估入学人数: | 04/18/2020 |
| 首次发布: | 04/21/2020 |
| 上次提交的更新: | 07/06/2020 |
| 最近更新发布: | 07/08/2020 |
| 实际学习开始日期: | 07/31/2020 |
| 预计主要完成日期: | 07/31/2021 |
| 预计完成日期: | 07/31/2021 |
状况或疾病
干预/治疗
Behavioral: All Participants
Behavioral: All Participants
Behavioral: All Participants
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: All Participants All participants will participate in virtual reality sessions as well as tablet-based sessions that mimic virtual reality content that serve as active control | Behavioral: All Participants 20-30 minute session of virtual reality immersive content. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Diagnosis of Traumatic Brain Injury - Age greater than or equal to 18 years-old - Glasgow Coma Scale of 15 - Expected to stay in the hospital for at least two days - Received opioids prescribed in the hospital in the last 24 hours - Patients must be able to consent for themselves Exclusion Criteria: - Seizure prior to enrollment - Pregnancy - non-English speaking - Known intolerance of Virtual Reality |
结果
主要结果指标
1. Change in Pain Score [Pre- and Post-Intervention (approximately 30 minutes)]
次要成果指标
1. Opioid Administration [6 hours]
其他成果措施
1. Change in Nausea [Pre- and Post-Intervention (approximately 30 minutes)]
2. Change in Anxiety [Pre- and Post-Intervention (approximately 30 minutes)]
3. Change in Galvanic Skin Response [Pre- and Post-Intervention (approximately 30 minutes)]
4. Change in Heart Rate Variability [Pre- and Post-Intervention (approximately 30 minutes)]
5. Change in pupillometry [Pre- and Post-Intervention (approximately 30 minutes)]
6. Subjective Measures of VR experience [Pre- and Post-study (approximately 2-3 days)]
