Department of Neurology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA.
BMJ Open. 2021 Nov 30;11(11):e056030. doi: 10.1136/bmjopen-2021-056030.
The annual mortality and national expense of the opioid crisis continue to rise in the USA (130 deaths/day, $50 billion/year). Opioid use disorder usually starts with the prescription of opioids for a medical condition. Its risk is associated with greater pain intensity and coping strategies characterised by pain catastrophising. Non-pharmacological analgesics in the hospital setting are critical to abate the opioid epidemic. One promising intervention is virtual reality (VR) therapy. It has performed well as a distraction tool and pain modifier during medical procedures; however, little is known about VR in the acute pain setting following traumatic injury. Furthermore, no studies have investigated VR in the setting of traumatic brain injury (TBI). This study aims to establish the safety and effect of VR therapy in the inpatient setting for acute traumatic injuries, including TBI.
In this randomised within-subjects clinical study, immersive VR therapy will be compared with two controls in patients with traumatic injury, including TBI. Affective measures including pain catastrophising, trait anxiety and depression will be captured prior to beginning sessions. Before and after each session, we will capture pain intensity and unpleasantness, additional affective measures and physiological measures associated with pain response, such as heart rate and variability, pupillometry and respiratory rate. The primary outcome is the change in pain intensity of the VR session compared with controls.
Dissemination of this protocol will allow researchers and funding bodies to stay abreast in their fields through exposure to research not otherwise widely publicised. Study protocols are compliant with federal regulation and University of Maryland Baltimore's Human Research Protections and Institutional Review Board (protocol number HP-00090603). Study results will be published on completion of enrolment and analysis, and deidentified data can be shared by request to the corresponding author.
NCT04356963; Pre-results.
在美国，阿片类药物危机的年死亡率和国家支出持续上升（每天 130 人死亡，每年 500 亿美元）。阿片类药物使用障碍通常始于因医疗状况而开具阿片类药物的处方。其风险与更大的疼痛强度和以疼痛灾难化为特征的应对策略有关。医院环境中的非药物性镇痛剂对于减轻阿片类药物流行至关重要。一种有前途的干预措施是虚拟现实（VR）疗法。它在医疗过程中作为分散注意力和疼痛调节剂表现良好；然而，在创伤后急性疼痛环境中，对 VR 的了解甚少。此外，尚无研究调查 VR 在创伤性脑损伤（TBI）中的应用。本研究旨在确定 VR 疗法在创伤性急性损伤住院患者中的安全性和效果，包括 TBI。
在这项随机的、个体内的临床研究中，沉浸式 VR 疗法将与创伤性损伤患者的两种对照进行比较，包括 TBI。在开始治疗前，将对包括疼痛灾难化、特质焦虑和抑郁在内的情感指标进行评估。在每次治疗前后，我们将记录疼痛强度和不愉快程度、额外的情感指标以及与疼痛反应相关的生理指标，如心率和变异性、瞳孔测量和呼吸频率。主要结果是与对照相比，VR 治疗的疼痛强度变化。
本方案的传播将使研究人员和资助机构通过接触其他未广泛宣传的研究来跟上他们所在领域的步伐。研究方案符合联邦法规和马里兰大学巴尔的摩分校的人类研究保护和机构审查委员会（协议编号 HP-00090603）。研究结果将在完成入组和分析后公布，可应要求向通讯作者共享去识别数据。
NCT04356963；预结果。
