A pilot study of a nature-based virtual reality (VR) intervention in family caregivers of allogeneic hematopoietic stem cell transplant (HSCT) recipients

本研究分为两个阶段。研究的第I阶段将是一项单组前后设计，重点评估VR干预的可行性和可接受性。研究的第二阶段将是一个前瞻性的随机对照组设计，以检查VR干预对感知压力的有效性。 将招募将在NIH临床中心接受同种异体HSCT的患者的主要照顾者成人（18岁或以上）。在患者开始移植预处理之前，将联系患者和护理人员参与研究。I期将入组15例受试者，II期将入组94例受试者（主动VR组N=47;假VR组N=47）。基于自然的VR干预将提供360个自然场景的高清视频沿着自然声音通过VR耳机每天20分钟，为期四周。 主要和次要结局是感知压力、压力相关症状（疲劳、睡眠障碍、抑郁、焦虑、认知受损）、压力生物标志物（皮质醇、α-淀粉酶、骨钙素、催产素）、心脏代谢生物标志物和炎症生物标志物。将进行两次关于VR用户体验的后续访谈。这项研究将提供早期证据，证明基于自然的VR干预是否可行，可接受，并有效地管理这一护理人员人群的压力和症状。 本研究于2023年5月16日获得IRB批准。招募工作尚未开始。

This study is a two-phase study. Phase I of the study will be a single-arm pre-post design focused on assessing the feasibility and acceptability of the VR intervention. Phase II of the study will be a prospective randomized controlled group design to examine the effectiveness of the VR intervention on perceived stress. Adults (18 years or older) who serve as primary caregivers for a person who will undergo an allogeneic HSCT at the Clinical Center, NIH, will be recruited. The patient and caregiver(s) will be approached for participation before the patients start their transplant conditioning. Fifteen participants will be enrolled for Phase I and 94 participants for Phase II (Active VR arm N=47; Sham VR arm N=47). The nature-based VR intervention will deliver 360 high-definition videos of nature scenes along with nature sounds via a VR headset for 20 minutes every day for four weeks. Primary and secondary outcomes are perceived stress, stress-related symptoms (fatigue, sleep disturbance, depression, anxiety, impaired cognition), stress biomarkers (cortisol, alpha-amylase, osteocalcin, oxytocin), cardiometabolic biomarkers, and inflammatory biomarkers. Two follow-up interviews on VR user experience will be conducted. This study will provide early evidence of whether nature-based VR interventions are feasible, acceptable, and effective for managing stress and symptoms in this caregiver population. The study was approved by the IRB on May 16, 2023. The recruitment has not begun yet.