Smartphone-based Virtual Reality Exposure and Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit

NCT05050123 | Terminated

• 1 other identifier: 21-004947
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare a smartphone-based virtual reality exposure with standard relaxation training for anxiety and associated symptoms (including pain) on an inpatient psychiatric unit, and whether patients find it usable and beneficial.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (1)

• Change in anxiety

  Assessment of anxiety with Subjective Units of Distress Scale (SUDS); this 0-100 scale has anchors and guidance for patients to rate their anxiety, 100 is "highest anxiety/distress you have ever felt", 50 is "moderate anxiety/distress; uncomfortable, but can continue to function", and 0 is "no stress; totally relaxed".

  Baseline, approximately 90 minutes

Secondary Outcomes (5)

• Change in associated emotions rating

  Baseline, approximately 90 minutes

• Change in pain

  Baseline, approximately 90 minutes

• Change in blood pressure

  Baseline, approximately 90 minutes

• Change in heart rate

  Baseline, approximately 90 minutes

• Change in respiratory rate

  Baseline, approximately 90 minutes

Study Arms (2)

First episode of anxiety: standard relaxation training

ACTIVE COMPARATOR

During a subject's first episode of anxiety the subject will be offered a session of standard relaxation training.

Behavioral: Standard relaxation training

Second episode of anxiety: virtual reality relaxation

EXPERIMENTAL

During a subject's second episode of anxiety the subject will be offered a session of virtual reality exposure available through the iPhone Google Cardboard virtual reality meditation/relaxation app.

Behavioral: iPhone Google Cardboard virtual reality meditation/relaxation app

Interventions

iPhone Google Cardboard virtual reality meditation/relaxation app BEHAVIORAL

Virtual reality meditation/relaxation app that has 6 scenes of 360° visual imagery with soothing music. The patient can spend about 15 minutes exploring the app.

Second episode of anxiety: virtual reality relaxation

Standard relaxation training BEHAVIORAL

15 minute sessions of guided imagery using Mayo Clinic Patient Education CD-ROM "Relaxation for Your Mind and Body"

First episode of anxiety: standard relaxation training

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Hospitalized on inpatient Mayo Clinic Mood Disorders psychiatric unit (Generose 3W).

You may not qualify if:

• Inability to understand English.
• Patients with primary substance use disorders, primary psychotic disorders, major neurocognitive disorders and active self-harm behaviors and seizure disorders

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Kung, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: October 5, 2021
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)