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
Amartya Mukhopadhyay, Ravi Shankar, Wei Zhen Hong, Anjali Bundele, Koh Pei Si
BMJ Open October 26, 2024 DOI: 10.1136/bmjopen-2024-090550 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Pilot randomised controlled trial (single-centre, single-blind, parallel-group) Randomized Pilot study Peer reviewed |
|---|---|
| Sample size | 30 |
| Population | Caregivers of patients with end-stage kidney disease (ESKD) |
| Intervention | VR-guided mindfulness programme |
| Duration | 6-week intervention; assessments at baseline, post-intervention (6 weeks) and follow-up (12 weeks) |
| Measures | Zarit Burden Interview (ZBI), Depression Anxiety Stress Scale-21 (DASS-21), 36-Item Short Form Health Survey (SF-36), Five Facet Mindfulness Questionnaire (FFMQ) |
| Topics | Meditation |
| Registration | NCT06479200 |
| Key findings | The protocol describes a planned pilot trial to evaluate the efficacy and feasibility of a six-week home-based VR-guided mindfulness intervention for ESKD caregivers, compared with a sham VR control viewing relaxing nature videos. No results are reported; outcomes will include caregiver burden, stress, anxiety, depression, quality of life, mindfulness and feasibility measures. |
Abstract
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.