Not yet recruiting NCT06935604
Healing Hearts of Hospitalized Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR mindfulness application, Standard of Care (SOC).
- Who it may be relevant to
- Registry conditions: Well-Being, Psychological, Anxiety, Affect, Relaxation. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Healing Hearts of Hospitalized Patients With Virtual Reality: A Pragmatic, Crossover Trial
Overview
The study aims to evaluate the impact of a bedside-delivered virtual reality (VR) mindfulness experience on well-being and psychosocial outcomes among hospitalized adult patients compared to standard of care (SOC; no added mindfulness intervention).
Interventions
- Behavioral VR mindfulness application
Participants receiving the VR intervention will be instructed to wear a Meta Quest 2 headset (Meta, Inc., Menlo Park, CA) and participate in a VR mindfulness application that is specifically designed to promote mindfulness, relaxation, and emotional regulation via guided content delivered in an immersive environment. Participants will be asked to complete pre and post intervention surveys. - Behavioral Standard of Care (SOC)
Participants will undergo a 30-minute SOC window during which they will be asked to do whatever they would normally do for relaxation during hospitalization. Participants will be asked to complete pre and post intervention surveys.
Primary outcome measures
- Change in Mental Well-being [Time frame: baseline, immediately after the intervention]
Secondary outcome measures (5)
- STAI-Trait [Time frame: Baseline]
- Change in STAI-State [Time frame: Baseline, immediately after the intervention]
- Change in Positive and Negative Affect Schedule (PANAS) [Time frame: baseline, immediately after the intervention]
- Change in Relaxation State measured by the Relaxation State Questionnaire (RSQ) [Time frame: baseline, immediately after the intervention]
- Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey [Time frame: immediately after the intervention]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years and above
- Able to provide informed consent
- Able to follow verbal instructions
- Adequate motor skills for upper extremities to operate VR equipment
- Clinically stable
- English speaking
- Willing to participate in mindfulness activities
Exclusion criteria
- Severe cognitive impairment
- Clinically unstable
- Facial trauma prohibiting headset use
- Physical limitations in facial, neck, upper extremities that hinder use of VR equipment
- History of seizures or other neurological conditions
- Severe motion sickness
- Active nausea
- Severe visual impairment
- Severe cognitive impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Stanford Health Care (SHC) — Palo Alto
Identifiers
NCT: NCT06935604 · 80473