PDF(Pubmed)
Abstract：
Millions of family members and/or friends in the U.S. serve as unpaid caregivers for individuals with chronic conditions, such as cancer. Caregiving for someone undergoing an intense allogeneic hematopoietic stem cell transplant (HSCT) is particularly demanding, with accompanying physical and psychological stress. Increased stress and stress-related symptoms could make it difficult for caregivers to fulfill their roles and could negatively impact the health status and quality of life of themselves and the recipients. Virtual reality (VR) is a promising technology increasingly used for treatment and wellness in various medical settings. There is growing evidence that studies have reported the positive effects of the VR intervention in managing and reducing stress among diverse populations in various clinical scenarios; however, no published studies have focused on family caregivers of patients with cancer. The study aims to assess the feasibility and acceptability of a four-week nature-based VR intervention and to examine the effectiveness of the VR intervention on stress in HSCT caregivers. This study comprises two phases. 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) who serve as primary caregivers for a person who will undergo an allogeneic HSCT will be recruited. 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 immersive VR program contains 360° high-definition videos of nature scenes along with nature sounds through a head-mounted display (HMD) for 20 minutes every day for four weeks. Primary outcome is perceived stress measured by the Perceived Stress Scale. Secondary/exploratory outcomes are stress-related symptoms (e.g., fatigue, sleep disturbance) and physiological biomarkers (e.g., cortisol, alpha-amylase). The importance and innovativeness of this study consist of using a first-of-its-kind, immersive VR technology to target stress and investigating the health outcomes assessed by validated objective biomarkers as well as self-report measures of the nature-based intervention in the caregiver population.
UNASSIGNED: ClinicalTrials.gov, identifier NCT05909202.
UNASSIGNED: ClinicalTrials.gov, identifier NCT05909202.
摘要：
在美国，数百万家庭成员和/或朋友是慢性病患者的无偿照顾者，比如癌症。照顾接受强烈异基因造血干细胞移植（HSCT）的人特别苛刻，伴随着身体和心理压力。压力和压力相关症状的增加可能使护理人员难以履行其职责，并可能对自己和接受者的健康状况和生活质量产生负面影响。虚拟现实（VR）是一种有前途的技术，越来越多地用于各种医疗环境中的治疗和健康。越来越多的证据表明，研究报告了VR干预在各种临床场景中管理和减少不同人群压力方面的积极作用；然而，没有发表的研究关注癌症患者的家庭照顾者。该研究旨在评估为期四周的基于自然的VR干预的可行性和可接受性，并研究VR干预对HSCT护理人员压力的有效性。本研究包括两个阶段。该研究的第一阶段将是一个单臂pre-post设计，重点是评估VR干预的可行性和可接受性。该研究的第二阶段将是一项前瞻性随机对照小组设计，以检查VR干预对感知压力的有效性。将招募作为将接受同种异体HSCT的人的主要照顾者的成年人（≥18岁）。15名参与者将被注册为I期，94名参与者将被注册为II期（主动VR臂N=47;假VR臂N=47）。基于自然的沉浸式VR程序包含自然场景的360°高清视频以及通过头戴式显示器（HMD）每天20分钟的自然声音，持续四个星期。主要结果是通过感知压力量表测量的感知压力。次要/探索性结果是与压力相关的症状(例如，疲劳,睡眠障碍)和生理生物标志物(例如，皮质醇,α-淀粉酶）。这项研究的重要性和创新性包括使用首创的，沉浸式VR技术以压力为目标，并调查通过有效的客观生物标志物评估的健康结果，以及在照顾者人群中基于自然的干预措施的自我报告措施。
■ClinicalTrials.gov,标识符NCT05909202。
■ClinicalTrials.gov,标识符NCT05909202。
