AnxietyNCT05050123
Smartphone-based Virtual Reality Exposure and Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit
A study testing iPhone Google Cardboard virtual reality meditation/relaxation app and Standard relaxation training in people with Anxiety and Pain, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- What is being tested?
- iPhone Google Cardboard virtual reality meditation/relaxation app and Standard relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hospitalized on inpatient Mayo Clinic Mood Disorders psychiatric unit (Generose 3W).
Who cannot join
- Inability to understand English.
- Patients with primary substance use disorders, primary psychotic disorders, major neurocognitive disorders and active self-harm behaviors and seizure disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Comparing a Smartphone-based Virtual Reality Exposure With Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit
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.
Read the 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.
- Being tested
- iPhone Google Cardboard virtual reality meditation/relaxation app, Standard relaxation training
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPhone Google Cardboard virtual reality meditation/relaxation appBehavioural
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 trainingBehavioural
15 minute sessions of guided imagery using Mayo Clinic Patient Education CD-ROM "Relaxation for Your Mind and Body"
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: iPhone Google Cardboard virtual reality meditation/relaxation app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline, approximately 90 minutes
Secondary outcomes (5)
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
Measured: Baseline, approximately 90 minutes
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.
Measured: Baseline, approximately 90 minutes
Change in blood pressure
Measured in mmHg
Measured: Baseline, approximately 90 minutes
Change in heart rate
Measured in beats per minute
Measured: Baseline, approximately 90 minutes
Change in respiratory rate
Measured in breaths per minute
Measured: Baseline, approximately 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start5 Oct 2021
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Why it stopped: Study stopped due to lack of personnel and budget.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Kung, Mayo Clinic
- Investigators
- Simon Kung, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050123
- Sponsor's protocol ID
- 21-004947
- Status last verified
- Aug 2023
- First submitted
- 10 Sep 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Smartphone-based Virtual Reality Exposure With Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit
- ClinicalTrials.gov ID
- NCT05050123
- Acronym / sponsor ID
- 21-004947
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to lack of personnel and budget.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First episode of anxiety: standard relaxation training | Active comparator | Behavioral: Standard relaxation trainingDuring 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 | Experimental | Behavioral: iPhone Google Cardboard virtual reality meditation/relaxation appDuring 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Hospitalized on inpatient Mayo Clinic Mood Disorders psychiatric unit (Generose 3W).
Key exclusion criteria (2 listed)
- Inability to understand English.
- Patients with primary substance use disorders, primary psychotic disorders, major neurocognitive disorders and active self-harm behaviors and seizure disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPhone Google Cardboard virtual reality meditation/relaxation appVirtual 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. | Behavioural | Second episode of anxiety: virtual reality relaxation |
| Standard relaxation training15 minute sessions of guided imagery using Mayo Clinic Patient Education CD-ROM "Relaxation for Your Mind and Body" | Behavioural | First episode of anxiety: standard relaxation training |
Primary outcome
Change in anxiety
Time frame: 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".
5 secondary outcomes
Change in associated emotions rating
Time frame: Baseline, approximately 90 minutes
Change in pain
Time frame: Baseline, approximately 90 minutes
Change in blood pressure
Time frame: Baseline, approximately 90 minutes
Change in heart rate
Time frame: Baseline, approximately 90 minutes
Change in respiratory rate
Time frame: Baseline, approximately 90 minutes
Results and safety
The study was stopped early (reason given: Study stopped due to lack of personnel and budget.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Kung, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPhone Google Cardboard virtual reality meditation/relaxation app and Standard relaxation training in people with Anxiety and Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study stopped due to lack of personnel and budget.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety (time frame: Baseline, approximately 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.