VR-Guided Mindfulness for ESKD Caregiver Well-Being

NCT06479200 | Not Yet Recruiting

• 1 other identifier: AlexandraHospital
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Failure, Chronic

Keywords

virtual reality; mindfulness; caregiver burden; end-stage kidney disease; pilot randomized controlled trial

Outcome Measures

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.

  Baseline to 6 weeks (post-intervention)

Secondary Outcomes (9)

• Change in Stress, anxiety, and depression

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

• Change in Quality of Life

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

• Change in Mindfulness

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

• Accrual rate

  Throughout the study period (12 weeks)

• Retention rate

  Throughout the study period (12 weeks)

Study Arms (2)

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.

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.

Other: Sham VR

Interventions

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.

Also known as: Virtual reality mindfulness, VR mindfulness

VR-guided mindfulness intervention

Sham VR OTHER

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.

Also known as: Control VR, Placebo VR

Sham VR control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandra Hospital: lead

Related Publications (1)

• 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.

  PMID: 39438104 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Caregiver Burden

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. Participants and outcome assessors are blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow (Medical Affairs, Alexandra Hospital); Principal Investigator, VR-Guided Mindfulness for ESKD Caregiver Well-Being Study

Model Details: This study uses a parallel group design with two arms: a VR-guided mindfulness intervention group and a sham VR control group.

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 28, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available within 12 months after the completion of the study and publication of primary results. The data will remain available for a period of 5 years from the date of publication.
• Access Criteria: Researchers interested in accessing the data should submit a formal request to the corresponding author, outlining their research question and proposed analyses. Requests will be reviewed by the study team to ensure the proposed use aligns with participant consent and ethical approvals. Approved researchers will be required to sign a data access agreement to ensure data protection and appropriate use.