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 depre...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/10/e090550.full |
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| author | Amartya Mukhopadhyay Ravi Shankar Wei Zhen Hong Anjali Bundele Koh Pei Si |
| author_facet | Amartya Mukhopadhyay Ravi Shankar Wei Zhen Hong Anjali Bundele Koh Pei Si |
| author_sort | Amartya Mukhopadhyay |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-015ec573a2ae45e7944b63e7763be402 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-015ec573a2ae45e7944b63e7763be4022025-08-20T02:49:02ZengBMJ Publishing GroupBMJ Open2044-60552024-10-01141010.1136/bmjopen-2024-090550Virtual 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 trialAmartya Mukhopadhyay0Ravi Shankar1Wei Zhen Hong2Anjali Bundele3Koh Pei Si4Division of Respiratory and Critical Care Medicine, Department of Medicine, National University Hospital, SingaporeMedical Affairs – Research, Innovation & Enterprise, Alexandra Hospital, SingaporeFast and Chronic Programmes, Alexandra Hospital, SingaporeMedical Affairs – Research, Innovation & Enterprise, Alexandra Hospital, SingaporeDepartment of Nursing, University Medicine Cluster, National University Hospital, SingaporeIntroduction 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.https://bmjopen.bmj.com/content/14/10/e090550.full |
| spellingShingle | Amartya Mukhopadhyay Ravi Shankar Wei Zhen Hong Anjali Bundele Koh Pei Si 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/10/e090550.full |
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