Healing Hearts of Hospitalized Patients

Healing Hearts of Hospitalized Patients With Virtual Reality: A Pragmatic, Crossover Trial

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Affect; Relaxation; Well-Being, Psychological
• Intervention / Treatment: Behavioral: VR mindfulness application; Behavioral: Standard of Care (SOC)

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Caruso, MD, PhD; Phone Number: 6504970927; Email: tjcaruso@stanford.edu
• Study Contact Backup: Name: Man Yee Suen, MD; Phone Number: 6504970927; Email: smy822@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Health Care (SHC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	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.
Experimental: VR Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mental Well-being	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	baseline, immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI-Trait	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.	Baseline
Change in STAI-State	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.	Baseline, immediately after the intervention
Change in Positive and Negative Affect Schedule (PANAS)	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)	baseline, immediately after the intervention
Change in Relaxation State measured by the Relaxation State Questionnaire (RSQ)	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.	baseline, immediately after the intervention
Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey	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.	immediately after the intervention

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 12, 2025
• First Submitted That Met QC Criteria: April 12, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality
• Additional Relevant MeSH Terms: Mental Disorders; Behavior; Personal Satisfaction; Anxiety Disorders; Psychological Well-Being; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 80473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No