Protocol for Pilot Randomized Controlled Trial: Virtual Reality-Guided Mindfulness Intervention on Psychosocial Well-Being of End-Stage Kidney Disease Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in Caregiver Burden
研究概览
简要总结
This pilot randomized controlled trial aims to evaluate the efficacy and feasibility of a virtual reality (VR)-guided mindfulness intervention for caregivers of patients with end-stage kidney disease (ESKD). Thirty ESKD caregivers will be randomly assigned to either a 6-week VR-guided mindfulness intervention or a sham VR control group. The study will assess changes in caregiver burden, stress, anxiety, depression, quality of life, and mindfulness using validated questionnaires. Feasibility outcomes, including recruitment, retention, adherence, and participant experiences, will also be evaluated. The findings will inform the design of a future larger-scale trial and may lead to the development of an accessible, technology-based support option for ESKD caregivers.
详细描述
Background:
Caregivers of patients with end-stage kidney disease (ESKD) face significant challenges that contribute to caregiver burden, negatively impacting their psychosocial well-being. Despite the well-documented challenges, support options for this population remain limited. Virtual reality (VR)-guided mindfulness interventions have shown promise in reducing stress, anxiety, and depression in various populations. This pilot study aims to evaluate the efficacy and feasibility of a VR-guided mindfulness intervention specifically designed for ESKD caregivers.
Objectives:
Assess the efficacy of a VR-guided mindfulness intervention compared to a sham VR control on caregiver burden and related psychosocial outcomes in ESKD caregivers.
Evaluate the feasibility and acceptability of the VR-guided mindfulness intervention for ESKD caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a single-blind study. Participants and outcome assessors are blinded to group allocation.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 years or older
- •Primary caregiver of a patient with end-stage kidney disease (ESKD) (stage 4 & 5 with - estimated glomerular filtration rate < 30 mL/min/1.73 m²)
- •Proficient in English
排除标准
- •Known visual or hearing impairments
- •History of motion sickness
- •Active psychosis or suicidal ideation
- •Current regular mindfulness practice
- •History of seizure, stroke, or head injury
结局指标
主要结局
Change in Caregiver Burden
时间窗: Baseline to 6 weeks (post-intervention)
Change in caregiver burden as measured by the Zarit Burden Interview (ZBI). The ZBI is a validated 22-item questionnaire that assesses the level of burden experienced by caregivers. Scores range from 0 to 88, with higher scores indicating greater caregiver burden.
次要结局
- Participant Satisfaction(6 weeks (post-intervention))
- Change in Stress, anxiety, and depression(Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up))
- Change in Quality of Life(Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up))
- Change in Mindfulness(Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up))
- Adherence rate(Throughout the study period (12 weeks))
- Retention rate(Throughout the study period (12 weeks))
- Accrual rate(Throughout the study period (12 weeks))
- Questionnaire completion rate(Throughout the study period (12 weeks))
- side effect rate(Throughout the study period (12 weeks))
研究者
Ravi Shankar
Research Fellow (Medical Affairs, Alexandra Hospital); Principal Investigator, VR-Guided Mindfulness for ESKD Caregiver Well-Being Study
Alexandra Hospital