Virtual RealityCATH-VRNCT03490903
Coronary Angiography THerapeutic Virtual Reality
A study testing Virtual Reality, Fentanyl Injection and Midazolam injection in people with Virtual Reality and Atherosclerosis, run by University of California, Los Angeles.
Trial summary
The CATH-VR study will investigate the effect of virtual reality (VR) on patient pain, anxiety, and radial artery vasospasm during coronary angiography. Our hypothesis is that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Atherosclerosis, Coronary Artery Disease
- What is being tested?
- Virtual Reality, Fentanyl Injection and Midazolam injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 30 Jun 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years undergoing diagnostic coronary angiogram
Who cannot join
- Claustrophobia
- Seizure disorder
- Motion sickness
- Stroke within the past year
- Dementia
- Nausea
- Isolation status for infection control
- Do not wish to participate.
About this study
Official title: Coronary Angiography THerapeutic Virtual Reality: Investigating the Effect of Virtual Reality on Procedural Anxiety, Pain and Vasospasm
The CATH-VR study will investigate the effect of virtual reality (VR) on patient pain, anxiety, and radial artery vasospasm during coronary angiography. Our hypothesis is that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial artery. In addition, we hypothesize that the amount of opioid and benzodiazepine medications utilized for procedural sedation will be lower in the intervention arm. VR has gained recent attraction as an alternative or adjunctive treatment option for pain, but its effect on reducing procedural sedation has not been studied. We propose a single center, randomized control pilot study to further investigate. The patient population will include adults older than 18 years who present for outpatient diagnostic coronary angiography.
Read the detailed description
We plan to conduct a prospective, unblinded, randomized control pilot study to test our hypothesis that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial artery.
Patients will be eligible if they are greater than 18 years of age and undergoing an elective outpatient coronary angiogram with or without percutaneous intervention. Exclusion criteria will include patients with claustrophobia, seizure disorder, motion sickness, stroke within the past year, dementia, nausea, isolation status for infection control or those who do not wish to participate.
Outpatients undergoing routine coronary angiography with or without possible percutaneous intervention will be screened for enrollment criteria. Those who agree to participate will be randomized to either the intervention or control arm. Those randomized to the intervention arm and agree to participate in the study will wear a VR Headset and headphones; those who are randomized to the control will receive the standard of care, which is moderate sedation for patient anxiolysis and pain control during the case. In both arms, the patient and operator will still be able to communicate verbally if needed to assess for pain, to ask questions, or to ask for anxiolytic or analgesic medications as needed. The procedure will be completed when vascular sheaths are just about to be removed.
- Conditions
- Virtual Reality, Atherosclerosis, Coronary Artery Disease, Anxiety, Pain, Acute, Vasospasm;Peripheral
- Being tested
- Virtual Reality, Fentanyl Injection, Midazolam injection
- Keywords
- virtual reality, anxiety, vasospasm, pain, coronary artery angiography, angiogram, VR
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Anxiety Disorders, Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Subjects undergoing the Virtual Reality Intervention will be fitted with a VR headset and headphones, and undergo an immersive meditation experience provided by AppliedVR, Inc. The headphones will not be noise-cancelling, and the subject will be able to communicate with the physician or circulating nurse if needed.
Fentanyl InjectionDrug
Fentanyl is commonly administered to treat pain during invasive procedures such as coronary angiography. Intravenous fentanyl injection dosages are determined by the physician operator, and administered by the circulating nurse.
Midazolam injectionDrug
Midazolam is commonly administered to treat anxiety during invasive procedures such as coronary angiography. Intravenous midazolam injection dosages are determined by the physician operator, and administered by the circulating nurse.
| Study group | Role | What they receive |
|---|---|---|
| VR with or without Moderate Sedation | Experimental | Patients randomized to receive a Virtual Reality Intervention will be fitted with a VR headset and headphones and undergo a continuous immersive meditation experience. This will begin immediately prior to the start of the procedure, and continue until the procedure is completed.
Patient pain and anxiety levels will be frequently assessed by procedure operator and circulating nurse, and pain medication or anxiolytic medications will be administered in the absence of contraindications. Baseline amounts of sedation pre-procedurally will not be used in either arm. Pain and Anxiety Scores will be assessed pre, intra, and post-procedurally. If no contraindications, the operator will decide upon how much sedation medication to administer if indicated or requested. This is the usual manner in which pain and anxiety is treated in the cath lab. Receives: Device: Virtual Reality; Drug: Fentanyl Injection; Drug: Midazolam injection |
| Moderate Sedation without VR | Active comparator | Subjects randomized to the comparison arm will not undergo the Virtual Reality Intervention. Baseline amounts of sedation pre-procedurally will not be used in either arm. Subjects will be assessed periodically by physicians and/or circulating nurses for their pain and anxiety levels. The patient may also prompt the staff that they are anxious or in pain, and if no contraindications, the operator will decide upon how much medication to administer. This is the usual manner in which pain and anxiety is treated in the cath lab. Receives: Drug: Fentanyl Injection; Drug: Midazolam injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial Artery Vasospasm
Presence or Absence of Radial Artery Vasospasm, determined by procedure operator
Measured: Day 1
Pain
Participants will verbalize their level of pain using the Wong-Baker FACES® Score (0 - 10 point scale, 10 points = worst pain, 0 = no pain).
Measured: Day 1
Anxiety
Participants will verbalize their level of anxiety by using the abbreviated State-Trait Anxiety Inventory 6 Score (Score Range 20-80, higher numbers correlate with higher levels of anxiety in a certain moment)
Measured: Day 1
Secondary outcomes (2)
Total fentanyl sedation
The total dose of fentanyl administered during the procedure
Measured: Day 1
Total midazolam sedation
The total dose of midazolam administered during the procedure
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Jun 2018 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Why it stopped: No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- AppliedVR Inc.
- Responsible party
- Principal investigator, David J. Cho, MD, MBA, University of California, Los Angeles
- Investigators
- David Cho, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490903
- Sponsor's protocol ID
- IRB#18-000026
- Acronym
- CATH-VR
- Status last verified
- Nov 2021
- First submitted
- 30 Mar 2018
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
PubMed 28356241Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
PubMed 29053848Buffum MD, Sasso C, Sands LP, Lanier E, Yellen M, Hayes A. A music intervention to reduce anxiety before vascular angiography procedures. J Vasc Nurs. 2006 Sep;24(3):68-73; quiz 74. doi: 10.1016/j.jvn.2006.04.001.
PubMed 16952777
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Angiography THerapeutic Virtual Reality: Investigating the Effect of Virtual Reality on Procedural Anxiety, Pain and Vasospasm
- ClinicalTrials.gov ID
- NCT03490903
- Acronym / sponsor ID
- CATH-VR / IRB#18-000026
- Conditions
- Virtual Reality, Atherosclerosis, Coronary Artery Disease, Anxiety, Pain, Acute, Vasospasm;Peripheral
- Keywords
- virtual reality, anxiety, vasospasm, pain, coronary artery angiography, angiogram, VR
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- AppliedVR Inc.
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 6 Apr 2018 (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 CATH-VR study will investigate the effect of virtual reality (VR) on patient pain, anxiety, and radial artery vasospasm during coronary angiography. Our hypothesis is that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial artery. In addition, we hypothesize that the amount of opioid and benzodiazepine medications utilized for procedural sedation will be lower in the intervention arm. VR has gained recent attraction as an alternative or adjunctive treatment option for pain, but its effect on reducing procedural sedation has not been studied. We propose a single center, randomized control pilot study to further investigate. The patient population will include adults older than 18 years who present for outpatient diagnostic coronary angiography.
Detailed description
We plan to conduct a prospective, unblinded, randomized control pilot study to test our hypothesis that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial artery.
Patients will be eligible if they are greater than 18 years of age and undergoing an elective outpatient coronary angiogram with or without percutaneous intervention. Exclusion criteria will include patients with claustrophobia, seizure disorder, motion sickness, stroke within the past year, dementia, nausea, isolation status for infection control or those who do not wish to participate.
Outpatients undergoing routine coronary angiography with or without possible percutaneous intervention will be screened for enrollment criteria. Those who agree to participate will be randomized to either the intervention or control arm. Those randomized to the intervention arm and agree to participate in the study will wear a VR Headset and headphones; those who are randomized to the control will receive the standard of care, which is moderate sedation for patient anxiolysis and pain control during the case. In both arms, the patient and operator will still be able to communicate verbally if needed to assess for pain, to ask questions, or to ask for anxiolytic or analgesic medications as needed. The procedure will be completed when vascular sheaths are just about to be removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR with or without Moderate Sedation | Experimental | Device: Virtual Reality, Drug: Fentanyl Injection, Drug: Midazolam injectionPatients randomized to receive a Virtual Reality Intervention will be fitted with a VR headset and headphones and undergo a continuous immersive meditation experience. This will begin immediately prior to the start of the procedure, and continue until the procedure is completed. Patient pain and anxiety levels will be frequently assessed by procedure operator and circulating nurse, and pain medication or anxiolytic medications will be administered in the absence of contraindications. Baseline amounts of sedation pre-procedurally will not be used in either arm. Pain and Anxiety Scores will be assessed pre, intra, and post-procedurally. If no contraindications, the operator will decide upon how much sedation medication to administer if indicated or requested. This is the usual manner in which pain and anxiety is treated in the cath lab. |
| Moderate Sedation without VR | Active comparator | Drug: Fentanyl Injection, Drug: Midazolam injectionSubjects randomized to the comparison arm will not undergo the Virtual Reality Intervention. Baseline amounts of sedation pre-procedurally will not be used in either arm. Subjects will be assessed periodically by physicians and/or circulating nurses for their pain and anxiety levels. The patient may also prompt the staff that they are anxious or in pain, and if no contraindications, the operator will decide upon how much medication to administer. This is the usual manner in which pain and anxiety is treated in the cath lab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age greater than or equal to 18 years undergoing diagnostic coronary angiogram
Key exclusion criteria (8 listed)
- Claustrophobia
- Seizure disorder
- Motion sickness
- Stroke within the past year
- Dementia
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 RealitySubjects undergoing the Virtual Reality Intervention will be fitted with a VR headset and headphones, and undergo an immersive meditation experience provided by AppliedVR, Inc. The headphones will not be noise-cancelling, and the subject will be able to communicate with the physician or circulating nurse if needed. | Device | VR with or without Moderate Sedation |
| Fentanyl InjectionFentanyl is commonly administered to treat pain during invasive procedures such as coronary angiography. Intravenous fentanyl injection dosages are determined by the physician operator, and administered by the circulating nurse. | Drug | Moderate Sedation without VR, VR with or without Moderate Sedation |
| Midazolam injectionMidazolam is commonly administered to treat anxiety during invasive procedures such as coronary angiography. Intravenous midazolam injection dosages are determined by the physician operator, and administered by the circulating nurse. | Drug | Moderate Sedation without VR, VR with or without Moderate Sedation |
Primary outcome
Radial Artery Vasospasm
Time frame: Day 1
Presence or Absence of Radial Artery Vasospasm, determined by procedure operator
Pain
Time frame: Day 1
Participants will verbalize their level of pain using the Wong-Baker FACES® Score (0 - 10 point scale, 10 points = worst pain, 0 = no pain).
Anxiety
Time frame: Day 1
Participants will verbalize their level of anxiety by using the abbreviated State-Trait Anxiety Inventory 6 Score (Score Range 20-80, higher numbers correlate with higher levels of anxiety in a certain moment)
2 secondary outcomes
Total fentanyl sedation
Time frame: Day 1
Total midazolam sedation
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Background: PubMed 28356241Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
- Background: PubMed 29053848Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
- Background: PubMed 16952777Buffum MD, Sasso C, Sands LP, Lanier E, Yellen M, Hayes A. A music intervention to reduce anxiety before vascular angiography procedures. J Vasc Nurs. 2006 Sep;24(3):68-73; quiz 74. doi: 10.1016/j.jvn.2006.04.001.
- Individual participant dataSharing planned: No
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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.
David Cho, MD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality, Fentanyl Injection and Midazolam injection in people with Virtual Reality and Atherosclerosis, run by University of California, Los Angeles.
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 8 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: withdrawn, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Radial Artery Vasospasm (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03490903, which also lists 3 linked publications.
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 16 Nov 2021.