Situational AnxietyNCT03169374
Virtual Reality for Anxiety Management in Mechanically Vented Patients
A study testing Virtual Reality Technology in people with Situational Anxiety, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety and feasibility of virtual reality for anxiety treatment in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Situational Anxiety
- What is being tested?
- Virtual Reality Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2017to 31 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Mechanically ventilated; defined as having an endotracheal tube or tracheostomy and requiring continuous support from a mechanical ventilator.
- Able to spontaneously maintain a state of wakefulness and alertness and able to follow commands
- Able to communicate with research staff; defined as writing or head nods/shakes
Who cannot join
- Delirious; defined as positive on the Confusion Assessment Method for the ICU (CAM-ICU +)
- Expected to be liberated from ventilator within 12 hours of potential enrollment
- Existence of skull injury or recent surgery (craniectomy) which precludes safely wearing VR visor
- Impaired ability to see or hear, as determined by study investigator
- Ventilator settings with positive end expiratory pressure (PEEP) greater than 10
- Inability to be safely removed from physical restraints for VR (virtual reality) sessions
Show all 11Show fewer
- Chronic ventilator dependence prior to the present hospitalization
- Lacking capacity to consent for one's self
- Known difficult airway; based on review of intubation note
- Tracheostomy performed within last seven days
- Pre-existing symptoms overlapping with major symptoms of cyber-sickness: Headache, Vertigo (dizziness), Ataxia (tremor with movement), Nausea, Vomiting.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the safety and feasibility of virtual reality for anxiety treatment in mechanically ventilated patients.
Read the detailed description
Mechanically ventilated patients (those on a breathing machine) often experience heightened levels of anxiety and discomfort. This is usually treated by using sedative medications, however these drugs often have unintended side effects. This study will investigate the safety and feasibility of using relaxing virtual reality environments for reduction of anxiety in mechanically ventilated patients.
- Conditions
- Situational Anxiety
- Being tested
- Virtual Reality Technology
- Keywords
- Virtual Reality, Mechanical Ventilation, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TechnologyDevice
Patients in this arm will participate in virtual reality sessions planned for 5 minutes at a time, during which they are shown relaxing virtual environments.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Technology | Experimental | Virtual Reality Therapy Receives: Device: Virtual Reality Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of safety events
Occurrence rate of safety events, defined as cardiac arrhythmias, hypotension, hypertension, oxygen desaturation, falls to the floor, or unintentional removal of a medical tube or device.
Measured: Immediately following treatment session
Secondary outcomes (1)
Change in anxiety level during virtual reality treatment
Change in anxiety score from pre- to post-virtual reality treatment using a visual analog scale.
Measured: Immediately following treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start9 Nov 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Situational AnxietyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Wacker, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169374
- Sponsor's protocol ID
- STUDY00000220
- Status last verified
- Sep 2021
- First submitted
- 17 May 2017
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Anxiety Management in Mechanically Vented Patients
- ClinicalTrials.gov ID
- NCT03169374
- Acronym / sponsor ID
- STUDY00000220
- Conditions
- Situational Anxiety
- Keywords
- Virtual Reality, Mechanical Ventilation, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 30 May 2017 (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 investigate the safety and feasibility of virtual reality for anxiety treatment in mechanically ventilated patients.
Detailed description
Mechanically ventilated patients (those on a breathing machine) often experience heightened levels of anxiety and discomfort. This is usually treated by using sedative medications, however these drugs often have unintended side effects. This study will investigate the safety and feasibility of using relaxing virtual reality environments for reduction of anxiety in mechanically ventilated patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Technology | Experimental | Device: Virtual Reality TechnologyVirtual Reality Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years or older
- Mechanically ventilated; defined as having an endotracheal tube or tracheostomy and requiring continuous support from a mechanical ventilator.
- Able to spontaneously maintain a state of wakefulness and alertness and able to follow commands
- Able to communicate with research staff; defined as writing or head nods/shakes
Key exclusion criteria (11 listed)
- Delirious; defined as positive on the Confusion Assessment Method for the ICU (CAM-ICU +)
- Expected to be liberated from ventilator within 12 hours of potential enrollment
- Existence of skull injury or recent surgery (craniectomy) which precludes safely wearing VR visor
- Impaired ability to see or hear, as determined by study investigator
- Ventilator settings with positive end expiratory pressure (PEEP) greater than 10
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 |
|---|---|---|
| Virtual Reality TechnologyPatients in this arm will participate in virtual reality sessions planned for 5 minutes at a time, during which they are shown relaxing virtual environments. | Device | Virtual Reality Technology |
Primary outcome
Incidence of safety events
Time frame: Immediately following treatment session
Occurrence rate of safety events, defined as cardiac arrhythmias, hypotension, hypertension, oxygen desaturation, falls to the floor, or unintentional removal of a medical tube or device.
1 secondary outcome
Change in anxiety level during virtual reality treatment
Time frame: Immediately following treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Situational Anxiety
RecruitingObservational study
Operating-Room Distractions, Surgeon Workload, Anxiety, Teamwork and Intraoperative Adverse Events (ORCHESTRA)
Colorectal Diseases, Anal Diseases
Recruiting
Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People
Situational Anxiety
Recruiting
Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures
Situational Anxiety, Behavior
Not yet recruitingObservational study
Cognitive Load Assessment of Helicopter Pilots in Training
Cognitive Impairment, Situational Anxiety
Recruiting
Home Within the Heart: a Playful Journey to Strengthen Family Resilience
Family Resilience, Short-term Therapy
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.
David Wacker, M.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Technology in people with Situational Anxiety, run by University of Minnesota 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 1 Oct 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of safety events (time frame: Immediately following treatment session). 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 1 Oct 2021.