Reducing Adult Inpatients Anxiety With Virtual Reality Meditation

Reducing Adult Inpatients Anxiety With Virtual Reality Meditation: A Prospective, Randomized Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Virtual Reality
• Intervention / Treatment: Behavioral: Virtual Reality headset with calming scenery

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Man Yee Suen; Phone Number: 650-723-5728; Email: msuen@stanfordchildrens.org
• Study Contact Backup: Name: Thomas Caruso; Phone Number: 650-723-5728; Email: tjcaruso@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Health Care (SHC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; 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; Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes
No Intervention: Control; No intervention (i.e. virtual reality headset) will be applied to the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Thomas Caruso, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 73841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No