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

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Abstract

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 1st subject was enrolled in June 2024. Enrollment is ongoing.