Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2026-01-13 @ 11:49 AM
Study NCT ID:
NCT06479200
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR-Guided Mindfulness for ESKD Caregiver Well-Being
Sponsor:
Alexandra Hospital
Organization:
Study Overview
Official Title:
Protocol for Pilot Randomized Controlled Trial: Virtual Reality-Guided Mindfulness Intervention on Psychosocial Well-Being of End-Stage Kidney Disease Caregivers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Explore participants' subjective experiences with the intervention and sham control through qualitative interviews.
Estimate effect sizes and variability to inform sample size calculations for a future definitive trial.
Methods:
This single-center, single-blind, parallel-group pilot randomized controlled trial will recruit 30 ESKD caregivers from Alexandra Hospital, Singapore. Participants will be randomly allocated to either the VR-guided mindfulness intervention group or the sham VR control group using a 1:1 allocation ratio.
Intervention:
The intervention group will receive a 6-week home-based VR-guided mindfulness program using an Oculus Quest 3 (or equivalent) headset. Participants will be instructed to practice 10-15 minutes of VR-guided mindfulness daily. The program will include guided meditation practices such as body scans, breath awareness, and loving-kindness meditation, delivered in immersive virtual environments designed to promote relaxation and focus.
Control:
The sham VR control group will receive a 6-week home-based intervention viewing relaxing nature videos without mindfulness content, matched for duration and VR experience.
Outcomes:
Primary outcomes include caregiver burden (Zarit Burden Interview), stress, anxiety, depression (Depression Anxiety Stress Scale-21), quality of life (Kidney Disease Quality of Life Short Form), and mindfulness (Five Facet Mindfulness Questionnaire). These will be assessed at baseline, post-intervention (6 weeks), and follow-up (12 weeks).
Feasibility outcomes include accrual rate, retention rate, adherence rate, questionnaire completion rate, and side effect rate. Acceptability will be assessed through participant satisfaction questionnaires and semi-structured interviews with a subset of participants.
Data Analysis:
Quantitative data analysis will focus on estimating effect sizes for between-group differences in change scores for each outcome measure. Feasibility outcomes will be reported descriptively. Qualitative data from interviews will be analyzed using thematic analysis.
Potential Impact:
If the intervention demonstrates promising results, it could lead to the development of a low-cost, accessible, and scalable approach to reducing caregiver burden and improving psychosocial well-being among ESKD caregivers. The findings will inform the design and conduct of a future definitive RCT, which could have important implications for clinical practice and healthcare policy in supporting ESKD caregivers.
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.
Explore participants' subjective experiences with the intervention and sham control through qualitative interviews.
Estimate effect sizes and variability to inform sample size calculations for a future definitive trial.
Methods:
This single-center, single-blind, parallel-group pilot randomized controlled trial will recruit 30 ESKD caregivers from Alexandra Hospital, Singapore. Participants will be randomly allocated to either the VR-guided mindfulness intervention group or the sham VR control group using a 1:1 allocation ratio.
Intervention:
The intervention group will receive a 6-week home-based VR-guided mindfulness program using an Oculus Quest 3 (or equivalent) headset. Participants will be instructed to practice 10-15 minutes of VR-guided mindfulness daily. The program will include guided meditation practices such as body scans, breath awareness, and loving-kindness meditation, delivered in immersive virtual environments designed to promote relaxation and focus.
Control:
The sham VR control group will receive a 6-week home-based intervention viewing relaxing nature videos without mindfulness content, matched for duration and VR experience.
Outcomes:
Primary outcomes include caregiver burden (Zarit Burden Interview), stress, anxiety, depression (Depression Anxiety Stress Scale-21), quality of life (Kidney Disease Quality of Life Short Form), and mindfulness (Five Facet Mindfulness Questionnaire). These will be assessed at baseline, post-intervention (6 weeks), and follow-up (12 weeks).
Feasibility outcomes include accrual rate, retention rate, adherence rate, questionnaire completion rate, and side effect rate. Acceptability will be assessed through participant satisfaction questionnaires and semi-structured interviews with a subset of participants.
Data Analysis:
Quantitative data analysis will focus on estimating effect sizes for between-group differences in change scores for each outcome measure. Feasibility outcomes will be reported descriptively. Qualitative data from interviews will be analyzed using thematic analysis.
Potential Impact:
If the intervention demonstrates promising results, it could lead to the development of a low-cost, accessible, and scalable approach to reducing caregiver burden and improving psychosocial well-being among ESKD caregivers. The findings will inform the design and conduct of a future definitive RCT, which could have important implications for clinical practice and healthcare policy in supporting ESKD caregivers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: