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

Primary Purpose

Anxiety, Pain

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

iPhone Google Cardboard virtual reality meditation/relaxation app

Standard relaxation training

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

First episode of anxiety: standard relaxation training

Second episode of anxiety: virtual reality relaxation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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

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.

Change in blood pressure

Measured in mmHg

Change in heart rate

Measured in beats per minute

Change in respiratory rate

Measured in breaths per minute

Full Information

NCT ID

NCT05050123

First Posted

September 10, 2021

Last Updated

August 9, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05050123

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

Study stopped due to lack of personnel and budget.

Study Start Date

October 5, 2021 (Actual)

Primary Completion Date

December 17, 2021 (Actual)

Study Completion Date

December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First episode of anxiety: standard relaxation training

Arm Type

Active Comparator

Arm Description

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

Arm Title

Second episode of anxiety: virtual reality relaxation

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

iPhone Google Cardboard virtual reality meditation/relaxation app

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard relaxation training

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in anxiety

Description

Time Frame

Baseline, approximately 90 minutes

Secondary Outcome Measure Information:

Title

Change in associated emotions rating

Description

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

Time Frame

Baseline, approximately 90 minutes

Title

Change in pain

Description

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.

Time Frame

Baseline, approximately 90 minutes

Title

Change in blood pressure

Description

Measured in mmHg

Time Frame

Baseline, approximately 90 minutes

Title

Change in heart rate

Description

Measured in beats per minute

Time Frame

Baseline, approximately 90 minutes

Title

Change in respiratory rate

Description

Measured in breaths per minute

Time Frame

Baseline, approximately 90 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Kung, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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