NCT06935604

Brief 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).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 12, 2025

Last Update Submit

April 21, 2026

Conditions

Well-Being, PsychologicalAnxietyRelaxationAffect

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • STAI-Trait

    Baseline

  • Change in STAI-State

    Baseline, immediately after the intervention

  • Change in Positive and Negative Affect Schedule (PANAS)

    baseline, immediately after the intervention

  • Change in Relaxation State measured by the Relaxation State Questionnaire (RSQ)

    baseline, immediately after the intervention

  • Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey

    immediately after the intervention

Study Arms (2)

VR Group

EXPERIMENTAL
Behavioral: VR mindfulness applicationBehavioral: Standard of Care (SOC)

Standard of Care

ACTIVE COMPARATOR
Behavioral: VR mindfulness applicationBehavioral: Standard of Care (SOC)

Interventions

VR mindfulness applicationBEHAVIORAL

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 CareVR Group
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.

Standard of CareVR Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care (SHC)

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Psychological Well-BeingAnxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Thomas Caruso, MD, PhD

CONTACT

6504970927tjcaruso@stanford.edu

Man Yee Suen, MD

CONTACT

6504970927smy822@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 12, 2025

First Posted

April 20, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)