Kidney Failure, ChronicNCT06479200
VR-Guided Mindfulness for ESKD Caregiver Well-Being
A study testing VR-guided mindfulness in people with Kidney Failure, Chronic, run by Alexandra Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- VR-guided mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Protocol for Pilot Randomized Controlled Trial: Virtual Reality-Guided Mindfulness Intervention on Psychosocial Well-Being of End-Stage Kidney Disease Caregivers
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.
Read the 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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- VR-guided mindfulness, Sham VR
- Keywords
- virtual reality, mindfulness, caregiver burden, end-stage kidney disease, pilot randomized controlled trial
- Medical subject headings
- Kidney Failure, Chronic, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-guided mindfulnessBehavioural
Also called Virtual reality mindfulness, VR mindfulness
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 VROther
Also called Control VR, Placebo VR
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-guided mindfulness intervention | Experimental | Participants will receive a 6-week home-based VR-guided mindfulness intervention using the Oculus Quest 3 (or equivalent) headset and a mindfulness application. They will be instructed to practice 10-15 minutes of VR-guided mindfulness daily. The intervention will consist of guided meditation practices, such as body scans, breath awareness, and loving-kindness meditation, delivered in immersive virtual environments designed to promote relaxation and focus. Receives: Behavioral: VR-guided mindfulness |
| Sham VR control | Sham comparator | Participants will receive a 6-week home-based sham VR intervention. They will view relaxing nature videos without mindfulness content for 10-15 minutes daily, matched for duration and VR experience with the experimental group. The sham VR control condition will use the same VR headset as the intervention group but will not include any guided mindfulness practices or instructions. Receives: Other: Sham VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks (post-intervention)
Secondary outcomes (9)
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
Measured: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
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
Measured: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
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)
Measured: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
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
Measured: Throughout the study period (12 weeks)
Retention rate
The proportion of enrolled participants who complete the study, including post-intervention (6 weeks) and follow-up (12 weeks) assessments.
Measure: Number of participants completing the final follow-up assessment divided by the total number of participants enrolled Unit of Measure: Percent
Measured: Throughout the study period (12 weeks)
Adherence rate
The proportion of participants who complete at least 80% of the prescribed VR sessions (29 out of 36 sessions over 6 weeks).
Measure: Number of participants completing at least 29 VR sessions divided by the total number of participants in the intervention group Unit of Measure: Percent
Measured: Throughout the study period (12 weeks)
Questionnaire completion rate
The proportion of participants who complete all outcome questionnaires (ZBI, DASS-21, KDQOL-SF, and FFMQ) at each assessment time point (baseline, 6 weeks, and 12 weeks).
Measure: Number of participants completing all questionnaires at all time points divided by the total number of enrolled participants Unit of Measure: Percent
Measured: Throughout the study period (12 weeks)
side effect rate
The proportion of participants who report any adverse effects related to VR use (e.g., motion sickness, eye strain, headaches) throughout the study period.
Measure: Number of participants reporting at least one side effect divided by the total number of participants using VR (both intervention and control groups) Unit of Measure: Percent
Measured: Throughout the study period (12 weeks)
Participant Satisfaction
Assessment of participant satisfaction with the VR-guided mindfulness intervention using the Client Satisfaction Questionnaire-8 (CSQ-8). Measure: Total score on the CSQ-8 Unit of Measure: Points on a scale from 8 to 32
Measured: 6 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel group design with two arms: a VR-guided mindfulness intervention group and a sham VR control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravi Shankar, Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479200
- Sponsor's protocol ID
- AlexandraHospital
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final trial dataset, including individual participant data (IPD), will be made available to other researchers upon reasonable request. This will include de-identified participant data from the primary and secondary outcome measures.
Publications
Shankar R, Hong WZ, Bundele A, Si KP, Mukhopadhyay A. 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. 2024 Oct 22;14(10):e090550. doi: 10.1136/bmjopen-2024-090550.
PubMed 39438104
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Pilot Randomized Controlled Trial: Virtual Reality-Guided Mindfulness Intervention on Psychosocial Well-Being of End-Stage Kidney Disease Caregivers
- ClinicalTrials.gov ID
- NCT06479200
- Acronym / sponsor ID
- AlexandraHospital
- Conditions
- Kidney Failure, Chronic
- Keywords
- virtual reality, mindfulness, caregiver burden, end-stage kidney disease, pilot randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandra HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel group design with two arms: a VR-guided mindfulness intervention group and a sham VR control group.
| Arm | Type | Receives |
|---|---|---|
| VR-guided mindfulness intervention | Experimental | Behavioral: VR-guided mindfulnessParticipants will receive a 6-week home-based VR-guided mindfulness intervention using the Oculus Quest 3 (or equivalent) headset and a mindfulness application. They will be instructed to practice 10-15 minutes of VR-guided mindfulness daily. The intervention will consist of guided meditation practices, such as body scans, breath awareness, and loving-kindness meditation, delivered in immersive virtual environments designed to promote relaxation and focus. |
| Sham VR control | Sham comparator | Other: Sham VRParticipants will receive a 6-week home-based sham VR intervention. They will view relaxing nature videos without mindfulness content for 10-15 minutes daily, matched for duration and VR experience with the experimental group. The sham VR control condition will use the same VR headset as the intervention group but will not include any guided mindfulness practices or instructions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-guided mindfulnessAlso: Virtual reality mindfulness, VR mindfulnessThe 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. | Behavioural | VR-guided mindfulness intervention |
| Sham VRAlso: Control VR, Placebo VRThe 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. | Other | Sham VR control |
Primary outcome
Change in Caregiver Burden
Time frame: Baseline to 6 weeks (post-intervention)
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.
9 secondary outcomes
Change in Stress, anxiety, and depression
Time frame: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
Change in Quality of Life
Time frame: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
Change in Mindfulness
Time frame: Baseline to 6 weeks (post-intervention) and 12 weeks (follow-up)
Accrual rate
Time frame: Throughout the study period (12 weeks)
Retention rate
Time frame: Throughout the study period (12 weeks)
Adherence rate
Time frame: Throughout the study period (12 weeks)
Questionnaire completion rate
Time frame: Throughout the study period (12 weeks)
side effect rate
Time frame: Throughout the study period (12 weeks)
Participant Satisfaction
Time frame: 6 weeks (post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 39438104Shankar R, Hong WZ, Bundele A, Si KP, Mukhopadhyay A. 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. 2024 Oct 22;14(10):e090550. doi: 10.1136/bmjopen-2024-090550.
- Individual participant dataSharing planned: Yes. The final trial dataset, including individual participant data (IPD), will be made available to other researchers upon reasonable request. This will include de-identified participant data from the primary and secondary outcome measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VR-guided mindfulness in people with Kidney Failure, Chronic, run by Alexandra Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Caregiver Burden (time frame: Baseline to 6 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.