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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06234254
Other study ID # 73841
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2025
Est. completion date May 31, 2026

Study information

Verified date April 2024
Source Stanford University
Contact Thomas Caruso
Phone 650-723-5728
Email tjcaruso@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date May 31, 2026
Est. primary completion date May 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - between age 18-99 - hospitalized at Stanford Health Care - english-speaking Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Reality headset with calming scenery
Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Locations

Country Name City State
United States Stanford Health Care (SHC) Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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