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NCT Number: NCT06935604

Healing Hearts of Hospitalized Patients

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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Key information

Conditions

Well-Being, Psychological Affect Anxiety Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Psychological Well-Being Relaxation

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Health Care (SHC)

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Mental Well-being

    Time frame: 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

  1. STAI-Trait

    Time frame: 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.

  2. Change in STAI-State

    Time frame: 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.

  3. Change in Positive and Negative Affect Schedule (PANAS)

    Time frame: 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)

  4. Change in Relaxation State measured by the Relaxation State Questionnaire (RSQ)

    Time frame: 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.

  5. Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Man Yee Suen, MD

CONTACT

[email protected]

6504970927

Thomas Caruso, MD, PhD

CONTACT

[email protected]

6504970927

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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