Virtual reality-guided mindfulness intervention to enhance psychosocial well-being in caregivers of end-stage kidney disease patients: protocol for a mixed-methods pilot randomised controlled trial.

Introduction: Caregivers of patients with end-stage kidney disease (ESKD) face significant challenges that contribute to caregiver burden, negatively impacting their psychosocial well-being. Virtual-reality (VR)-guided mindfulness interventions have shown promise in reducing stress, anxiety and depression in various populations.

Methods And Analysis: This pilot study aims to evaluate the efficacy and feasibility of a VR-guided mindfulness intervention for ESKD caregivers. A single-centre, single-blind, parallel-group pilot randomised controlled trial will be conducted. Thirty ESKD caregivers will be randomly allocated to either the VR-guided mindfulness intervention group or the sham VR control group. The intervention group will receive a 6 week home-based VR-guided mindfulness programme, while the control group will view relaxing nature videos without mindfulness content. Participants will be assessed at baseline, post-intervention (6 weeks) and follow-up (12 weeks) using validated questionnaires for caregiver burden (Zarit Burden Interview (ZBI)), stress, anxiety, depression (Depression Anxiety Stress Scale-21 (DASS-21)), quality of life (36-Item Short Form Health Survey (SF-36)) and mindfulness (Five Facet Mindfulness Questionnaire (FFMQ)). Feasibility outcomes include accrual rates, retention, adherence, questionnaire completion and side effect rates. Semi-structured interviews will explore participants' experiences with the intervention.

Ethics And Dissemination: The study has been approved by the NHG Domain Specific Review Board (Reference: 2024-3940-APP1). The results of this pilot study will be reported in peer-reviewed open-access journals and shared with participants and stakeholders.

Trial Registration: NCT06479200.