Clinical trial NCT06479200: VR-Guided Mindfulness for ESKD Caregiver Well-Being
Official title: Protocol for Pilot Randomized Controlled Trial: Virtual Reality-Guided Mindfulness Intervention on Psychosocial Well-Being of End-Stage Kidney Disease Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Failure, Chronic
Keywords: virtual reality
mindfulness
caregiver burden
end-stage kidney disease
pilot randomized controlled trial
Lead sponsor: Alexandra Hospital
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel group design with two arms: a VR-guided mindfulness intervention group and a sham VR control group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Caregiver Burden
timeFrame: Baseline to 6 weeks (post-intervention)
Secondary outcomes:
measure: Change in Stress, anxiety, and depression
timeFrame: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
measure: Change in Quality of Life
timeFrame: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
measure: Change in Mindfulness
timeFrame: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
measure: Accrual rate
timeFrame: Throughout the study period (12 weeks)
measure: Retention rate
timeFrame: Throughout the study period (12 weeks)
measure: Adherence rate
timeFrame: Throughout the study period (12 weeks)
measure: Questionnaire completion rate
timeFrame: Throughout the study period (12 weeks)
measure: side effect rate
timeFrame: Throughout the study period (12 weeks)
measure: Participant Satisfaction
timeFrame: 6 weeks (post-intervention)
Other outcomes:
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