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VR-Guided Mindfulness for ESKD Caregiver Well-Being

ConditionKidney Failure, Chronic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorAlexandra Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Known visual or hearing impairments

History of motion sickness

Active psychosis or suicidal ideation

Current regular mindfulness practice

Trial design

Design model

Parallel

Treatments tested in this trial

  • VR-guided mindfulness

    Behavioral

    The VR-guided mindfulness intervention is a 6-week home-based program delivered through an Oculus Quest 3 (or equivalent) headset. Participants practice 10-15 minutes of guided mindfulness exercises daily in immersive virtual environments. The program includes various mindfulness techniques such as body scans, breath awareness, and loving-kindness meditation, designed to reduce stress and improve well-being.

  • Sham VR

    Other intervention

    The sham VR intervention is a 6-week home-based program that involves viewing relaxing nature videos without any mindfulness content. Participants use the same VR headset as the experimental group and engage with the sham content for 10-15 minutes daily, matching the duration of the experimental intervention. This sham intervention controls for the effects of using VR technology and engaging in a relaxing activity.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: VR-guided mindfulness interventionExperimental treatment 1 intervention
Group B: Sham VR controlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Caregiver Burden

Change in caregiver burden as measured by the Zarit Burden Interview (ZBI). The ZBI is a validated 22-item questionnaire that assesses the level of burden experienced by caregivers. Scores range from 0 to 88, with higher scores indicating greater caregiver burden.

Time frame
Baseline to 6 weeks (post-intervention)

Secondary outcomes

1

Change in Stress, anxiety, and depression

Change in stress, anxiety, and depression levels as measured by the Depression Anxiety Stress Scale-21 (DASS-21). The DASS-21 is a 21-item self-report questionnaire that measures the negative emotional states of depression, anxiety, and stress. Each subscale (Stress, Anxiety, Depression) consists of 7 items, scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Measure: Total score on the Depression Anxiety Stress Scale-21 (DASS-21) Unit of Measure: Points on a scale from 0 to 63 Direction: Lower scores indicate better outcome

Time frame
Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
2

Change in Quality of Life

Change in quality of life as measured by the Kidney Disease Quality of Life Short Form (KDQOL-SF). The KDQOL-SF is a kidney disease-specific measure of health-related quality of life that includes the SF-36 as generic core plus items about kidney disease. Measure: Overall score on the Kidney Disease Quality of Life Short Form (KDQOL-SF) Unit of Measure: Points on a scale from 0 to 100 Direction: Higher scores indicate better outcome

Time frame
Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
3

Change in Mindfulness

Change in mindfulness as measured by the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item questionnaire that assesses five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Measure: Total score on the Five Facet Mindfulness Questionnaire (FFMQ) Unit of Measure: Points on a scale from 39 to 195 Direction: Higher scores indicate better outcome (greater mindfulness)

Time frame
Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
4

Accrual rate

The proportion of eligible caregivers who agree to participate in the study out of the total number of eligible caregivers approached. Measure: Number of participants enrolled divided by the number of eligible caregivers approached Unit of Measure: Percent

Time frame
Throughout the study period (12 weeks)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandra Hospital

Lead sponsor

Source ClinicalTrials.gov

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