Healing Hearts of Hospitalized Patients With Virtual Reality: A Pragmatic, Crossover Trial
| Registry | NCT06935604 |
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, supportive care |
| Enrollment | 42 (Estimated) |
| Sponsor | Stanford University (Other) |
| Conditions | Well-Being, Psychological, Anxiety, Affect, Relaxation |
| Interventions | VR mindfulness application, Standard of Care (SOC) (Behavioral) |
| Dates | start 2026-05-07, primary completion 2027-05-31 (estimated), completion 2027-05-31 (estimated), first posted 2025-04-20, last updated 2026-08-18 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Well-Being, Psychological All trials for Anxiety All trials of VR mindfulness application All trials of Standard of Care (SOC)
-Summary
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).
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| VR Group | Experimental | Behavioral: VR mindfulness application; Behavioral: Standard of Care (SOC) | |
| Standard of Care | Active comparator | Behavioral: VR mindfulness application; Behavioral: Standard of Care (SOC) | |
- VR mindfulness application (Behavioral): 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.
- Standard of Care (SOC) (Behavioral): 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.
+Outcome measures
Primary outcomes
- Change in Mental Well-being [baseline, immediately after the intervention]: The World Health Organization - Five Well-Being Index (WHO-5) is a participant-reported outcome measure that assesses current mental well being. Questionnaire contains 5 questions. It scores five positively phrased items from 0 ("at no time") to 5 ("all of the time"), with a total raw score of 0-25, where lower scores indicate poorer well-being
Secondary outcomes
- STAI-Trait [Baseline]: The State-Trait Anxiety Inventory - Trait (STAI-T) is a 20-item self-report questionnaire measuring long-standing, stable anxiety tendencies. It is a 4-point Likert scale, ranging from 20-80, with higher scores indicating higher anxiety.
- Change in STAI-State [Baseline, immediately after the intervention]: The State-Trait Anxiety Inventory - State (STAI-S) is a 20-item self-report tool used to measure current, transient anxiety states. It is a 4-point Likert scale, ranging from 20-80, with higher scores indicating higher anxiety.
- Change in Positive and Negative Affect Schedule (PANAS) [baseline, immediately after the intervention]: The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire (10 positive, 10 negative) used to measure emotional state and affect regulation. It is a 5-point Likert scale (1 = Very Slightly/Not at All; 5 = Extremely)
- Change in Relaxation State measured by the Relaxation State Questionnaire (RSQ) [baseline, immediately after the intervention]: the Relaxation State Questionnaire (RSQ; Steghaus \& Poth, 2022) is a validated 10-item self-report instrument measuring momentary subjective relaxation states across four subscales: Muscle Scale, Cardiovascular Scale, General Relaxation Scale, and Sleepiness Scale. Each item is rated on a 5-point Likert scale (1 = Not correct at all to 5 = Entirely correct), with reverse-scored items as indicated.
- Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey [immediately after the intervention]: Participants will complete the Self-Developed Satisfaction survey. The instrument includes 4 closed-ended items with varying response formats. Three question is on a 5-point Likert scale (1 = Not at all, 5=Completely) and one is in "Check all that apply" format.
+Eligibility
Sex: All, ages: 18 Years to 99 Years
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Stanford Health Care (SHC) | Palo Alto, California | United States | Recruiting |