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

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05050123
Collaborator
(none)
50
1
2
12
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: iPhone Google Cardboard virtual reality meditation/relaxation app
  • Behavioral: Standard relaxation training
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Comparing a Smartphone-based Virtual Reality Exposure With Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: First episode of anxiety: standard relaxation training

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

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

Experimental: Second episode of anxiety: virtual reality relaxation

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in anxiety [Baseline, approximately 90 minutes]

    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".

Secondary Outcome Measures

  1. Change in associated emotions rating [Baseline, approximately 90 minutes]

    The patient will be asked to write up to 3 more associated emotions and rate them 0-10, 10=strongest intensity

  2. Change in pain [Baseline, approximately 90 minutes]

    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.

  3. Change in blood pressure [Baseline, approximately 90 minutes]

    Measured in mmHg

  4. Change in heart rate [Baseline, approximately 90 minutes]

    Measured in beats per minute

  5. Change in respiratory rate [Baseline, approximately 90 minutes]

    Measured in breaths per minute

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Simon Kung, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Simon Kung, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05050123
Other Study ID Numbers:
  • 21-004947
First Posted:
Sep 20, 2021
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2021