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

Not Applicable

Terminated

• Conditions: Anxiety; Pain
• Interventions: Behavioral: Standard relaxation training; Behavioral: iPhone Google Cardboard virtual reality meditation/relaxation app

• Registration Number: NCT05050123
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Study Start: 2021-10-05
• Primary Completion: 2021-12-17
• Study Completion: 2021-12-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First episode of anxiety: standard relaxation training	Standard relaxation training	During a subject's first episode of anxiety the subject will be offered a session of standard relaxation training.
Second episode of anxiety: virtual reality relaxation	iPhone Google Cardboard virtual reality meditation/relaxation app	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in heart rate	Baseline, approximately 90 minutes	Measured in beats per minute
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
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.
Change in blood pressure	Baseline, approximately 90 minutes	Measured in mmHg
Change in respiratory rate	Baseline, approximately 90 minutes	Measured in breaths per minute

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States