Well-Being, PsychologicalNCT06935604
Healing Hearts of Hospitalized Patients
A study testing VR mindfulness application in people with Well-Being, Psychological and Anxiety, run by Stanford University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Well-Being, Psychological, Anxiety, Affect
- What is being tested?
- VR mindfulness application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active nausea
- Severe visual impairment
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Health Care (SHC)
Palo Alto, California, 94304
Thomas Caruso, MD, Phd
About this study
Official title: 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).
- Conditions
- Well-Being, Psychological, Anxiety, Affect, Relaxation
- Being tested
- VR mindfulness application, Standard of Care (SOC)
- Keywords
- Virtual Reality
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR mindfulness applicationBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR Group | Experimental | Not described Receives: Behavioral: VR mindfulness application; Behavioral: Standard of Care (SOC) |
| Standard of Care | Active comparator | Not described Receives: Behavioral: VR mindfulness application; Behavioral: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, immediately after the intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start7 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935604
- Sponsor's protocol ID
- 80473
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Hearts of Hospitalized Patients With Virtual Reality: A Pragmatic, Crossover Trial
- ClinicalTrials.gov ID
- NCT06935604
- Acronym / sponsor ID
- 80473
- Conditions
- Well-Being, Psychological, Anxiety, Affect, Relaxation
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR mindfulness applicationParticipants 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. | Behavioural | Standard of Care, VR Group |
| 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. | Behavioural | Standard of Care, VR Group |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR mindfulness application in people with Well-Being, Psychological and Anxiety, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Caruso, MD, PhD (6504970927, tjcaruso@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mental Well-being (time frame: baseline, immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.