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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05050123
• Other study ID #: 21-004947
• Status: Terminated
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: December 17, 2021

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study is open only to inpatients on a specific Mayo Clinic Rochester psychiatric hospital unit, the Mood Disorders Unit. Two different techniques for reducing anxiety will be tried. The first time patients report anxiety, they will be asked to listen to a 15 minute audio CD guiding them through relaxation strategies. The second time patients are anxious, they will be given a cardboard VR goggle set and will view 15 minutes of unguided VR. Before and after each session, they will fill out a short survey of anxiety and related symptoms (including pain ratings) and their reaction to each technique. They will be asked to try each technique at least once during your hospital stay.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Behavioral:
• iPhone Google Cardboard virtual reality meditation/relaxation app
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.
• Standard relaxation training
15 minute sessions of guided imagery using Mayo Clinic Patient Education CD-ROM "Relaxation for Your Mind and Body"

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in associated emotions rating	The patient will be asked to write up to 3 more associated emotions and rate them 0-10, 10=strongest intensity	Baseline, approximately 90 minutes
Secondary	Change in pain	Assessment of pain with Numeric Pain Intensity Scale (NPIS); the scale is measured on a 0-10 scale with 0 equating to no pain and 10 being the most excruciating pain patient has ever felt.	Baseline, approximately 90 minutes
Secondary	Change in blood pressure	Measured in mmHg	Baseline, approximately 90 minutes
Secondary	Change in heart rate	Measured in beats per minute	Baseline, approximately 90 minutes
Secondary	Change in respiratory rate	Measured in breaths per minute	Baseline, approximately 90 minutes

External Links

•   Mayo Clinic Clinical Trials