Groenveld Tjitske D, Smits Indy Gm, Scholten Naomi, de Vries Marjan, van Goor Harry, Stirler Vincent Ma
Department of Surgery, Radboud University Medical Center, Nijmegen, Netherlands.
Department of Rehabilitation, Radboud University Medical Center, Nijmegen, Netherlands.
JMIR Serious Games. 2024 Dec 9;12:e54389. doi: 10.2196/54389.
Adequate pain relief, early restoration of breathing, and rapid mobilization pose a clinical challenge in patients with blunt chest trauma. Virtual reality (VR) has the potential to achieve these 3 interrelated treatment objectives with enhanced self-efficacy and autonomy of patients and limited support by clinicians.
This study aimed to assess the effectivity of breathing and physical exercises using VR on the pulmonary recovery of patients with blunt chest trauma at the ward.
A pilot randomized controlled trial was performed. The control group received usual physiotherapy consisting of protocolized breathing exercises (8 times daily for 10 minutes) and physical exercises (2 times daily for 10 minutes). The VR group was instructed to perform these exercises using VR. The primary outcome was vital lung capacity at day 5 or earlier at discharge. Secondary outcomes were patient mobility (time standing, lying, and sitting), clinical outcomes (length of hospital stay, pulmonary complications, transfer to intensive care unit, and readmission within 30 days), pain, activities of daily living, patient-reported outcome measures (satisfaction and quality of recovery). Patient experiences and barriers and facilitators toward implementation were assessed through interviews.
The study was prematurely ended due to enrollment failure combined with poor protocol adherence to exercises in both groups. A total of 27 patients were included, of which 19 patients completed 3 or more days. Vital lung capacity at 5 days (or last measurement) was equal between groups with 1830 (SD 591) mL and 1857 (SD 435) mL in the control and VR groups, respectively. No marked differences were observed in secondary outcomes. Patient interviews showed positive attitudes toward the use of VR, describing that visualization of the exercises helped patients to perform the exercises correctly and to continue the exercises for a longer duration. Also, patients experienced the immersiveness of VR as an analgesic. However, patients did not experience added value over usual care and reported that better integration in treatment and the hectic hospital environment could improve the use of the VR exercises.
The suitability of patients to use virtual reality therapy (VRx) in a hospital (trauma) ward setting is lower than generally expected. Effective application of VRx requires professional guidance and needs thorough alignment with clinical practice. For future research, we recommend to chart adherence to study protocol before designing a VR clinical trial. Patient-reported experiences need to be prioritized in evaluating VR acceptance, usability, and effectiveness. In line, we recommend performing a systematic analysis (eg, using the technology acceptance model) on the acceptance before pilot or main effectiveness studies. Finally, the eligibility of patients and exclusion of patients due to the inability to use VRx should be routinely reported.
ClinicalTrials.gov NCT05194176; https://tinyurl.com/2bzh4tzx.
在钝性胸部创伤患者中，实现充分的疼痛缓解、呼吸功能的早期恢复以及快速活动能力恢复是一项临床挑战。虚拟现实（VR）有潜力实现这三个相互关联的治疗目标，同时增强患者的自我效能感和自主性，并减少临床医生的支持。
本研究旨在评估使用VR进行呼吸和体育锻炼对病房中钝性胸部创伤患者肺部恢复的有效性。
进行了一项初步随机对照试验。对照组接受常规物理治疗，包括按规程进行的呼吸锻炼（每天8次，每次10分钟）和体育锻炼（每天2次，每次10分钟）。VR组被指导使用VR进行这些锻炼。主要结局是出院时第5天或更早的肺活量。次要结局包括患者活动能力（站立、躺卧和坐立时间）、临床结局（住院时间、肺部并发症、转入重症监护病房以及30天内再次入院）、疼痛、日常生活活动能力、患者报告的结局指标（满意度和恢复质量）。通过访谈评估患者的体验以及实施过程中的障碍和促进因素。
由于入组失败以及两组对锻炼规程的依从性差，该研究提前结束。共纳入27例患者，其中19例患者完成了3天或更长时间的治疗。对照组和VR组在第5天（或最后一次测量）的肺活量分别为1830（标准差591）mL和1857（标准差435）mL，两组之间无显著差异。次要结局方面未观察到明显差异。患者访谈显示对使用VR持积极态度，称锻炼的可视化有助于患者正确进行锻炼并持续更长时间。此外，患者体验到VR的沉浸感具有镇痛作用。然而，患者并未体验到VR相较于常规护理的额外价值，并表示更好地融入治疗以及繁忙的医院环境可以改善VR锻炼的使用。
患者在医院（创伤）病房环境中使用虚拟现实疗法（VRx）的适用性低于普遍预期。VRx的有效应用需要专业指导，并且需要与临床实践进行全面协调。对于未来的研究，我们建议在设计VR临床试验之前记录对研究规程的依从性。在评估VR的接受度、可用性和有效性时，应优先考虑患者报告的体验。同样，我们建议在进行初步或主要有效性研究之前，对接受度进行系统分析（例如使用技术接受模型）。最后，应常规报告患者使用VRx的资格以及因无法使用VRx而排除的患者情况。
ClinicalTrials.gov NCT05194176；https://tinyurl.com/2bzh4tzx
