NCT06234254

Brief Summary

The purpose of the study is to evaluate if non-invasive, distracting devices (virtual reality) can decrease anxiety and improve affect and satisfaction in adult, hospitalized patients.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable anxiety

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
2.3 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

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

January 22, 2024

Last Update Submit

May 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale (HADS)

    Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.

    Before and Immediate after intervention

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Behavioral: Virtual Reality headset with calming scenery

Control

NO INTERVENTION

No intervention (i.e. virtual reality headset) will be applied to the participant.

Interventions

Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Virtual Reality

Eligibility Criteria

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

You may qualify if:

  • between age 18-99
  • hospitalized at Stanford Health Care
  • english-speaking

You may not qualify if:

  • significant cognitive impairment or inability to consent
  • current nausea
  • visual problems or currently using corrective glasses that are incompatible with the virtual reality headset
  • a history of severe motion sickness
  • a history of seizures cause by flashing light
  • clinically unstable or require immediate/urgent intervention

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

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Thomas Caruso

    Stanford University

    STUDY DIRECTOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations