AnxietyVR InCardNCT06215456
Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography
A study testing Virtual reality therapy in people with Anxiety and Anxiety State, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Introduction Patients undergoing invasive coronary angiography experience anxiety due to various factors. This can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anxiety, Anxiety State
- What is being tested?
- Virtual reality therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Sep 2023to 30 Apr 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient ≥16 years undergoing elective cardiac catheterisation
- Patient is willing and able to comply with the study protocol
- NRS anxiety score ≥ 4
Who cannot join
- History of dementia
- Severe hearing/visual impairment not corrected
- Depression or anxiety disorder
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
Groenveld, MD, tjitske.groenveld@radboudumc.nl
About this study
Official title: Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography: Rationale and Design of the VR InCard Trial
Introduction Patients undergoing invasive coronary angiography experience anxiety due to various factors. This can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. VR is an promising nonpharmacological intervention that can be used to reduce anxiety in patients undergoing an invasive coronary angiography.
Methods and analysis A single-center open-label randomized controlled trial was performed to assess the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing invasive coronary angiography and experiencing anxiety in periprocedural setting. The primary outcome is the NRS anxiety score measured just before obtaining arterial access. Secondary outcomes are physiological measures of anxiety and the State-Trait Anxiety Inventory, Perceived Stress Scale, and IGroup presence questionnaire. The NRS anxiety level and physiological measurements will be taken at five scheduled times between pre procedural, peri and post procedural. The State-Trait Anxiety Inventory and Perceived Stress Scale will be performed prior to coronary angiography and the State-Trait Anxiety Inventory (state form) and the IGroup Presence questionnaire will be performed post-intervention.
- Conditions
- Anxiety, Anxiety State
- Being tested
- Virtual reality therapy
- Keywords
- Virtual reality therapy, Procedural anxiety, Invasive coronary angiography, nonpharmacological, Anxiolysis
- 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 therapyDevice
VR therapy will be applied using a head mounted display, the PICO G2 4K headset (Barcelona, Spain). For VRD de application'SyncVR Relax \& Distract' (SyncVR Medical, Utrecht, The Netherlands) will be used. This application contains a wide range of relaxation games, relaxing 360 videos, and relaxation exercises each with a duration of 5-20 minutes. Patients can choose videos, games, or exercises according to their own preferences. For VRH sessions, the application HypnoVR (Strasbourg, France) will be used. This app contains several hypnotic narratives integrating sequences of controlled breathing, cardiac coherence, and hypnotic suggestions. Each VRH sessions can be personalized through selecting different environments and musical compositions.The first VRH session will be set to last 20 minutes and the second VRH session will be set to the continuous setting.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will be treated according to local protocol. Unless contra-indicated, patients experiencing moderate to severe anxiety before undergoing ICA may receive preprocedural oxazepam (10 mg, oral) at the day care unit and diazepam (5 mg, intravenous) before arterial puncture at the catheterization room at nurses and physicians discretion. In patients planned for coronary function testing, benzodiazepines are withheld per protocol. |
| Virtual Reality therapy | Active comparator | The VR intervention group will receive two sessions of VRH in addition to standard care. Before starting the first guided session in this study, patients can use VR during the waiting time using SyncVR Relax \& Distract (SyncVR Medical, Utrecht, The Netherlands). Subsequently, the first session of VRH is administered at the day-care unit 20 minutes prior to the procedure. After the first session patients is transported to the catheterization room, where the treatment team have the possibility to introduce themselves to the patients. The second session of VRH is administered during arterial access puncture in the catheterization room, starting 5 minutes prior to puncture and terminating when the diagnostic or guiding coronary catheter is in position. The rest of the procedure will be continued without VR. Receives: Device: Virtual reality therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS anxiety
Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety imaginable.
Measured: Assessed at established moment right before start op procedure.
Secondary outcomes (19)
NRS anxiety
Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety
Measured: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
heart rate
Measured: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
blood pressure
Both systolic and diastolic blood pressure will be measured
Measured: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
heart rate variability
LF/HF ratio are extracted
Measured: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
heart rate variability
RMSSD (root mean square of the successive differences) is extracted
Measured: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
heart rate variability
SDNN (standard deviation of the NN (R-R) intervals) is extracted
Measured: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
respiration rate
Measured: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
STAI-state short form
State-Trait Anxiety Inventory - state section - 6 item. Score range 6-24. Higher score is higher anxiety.
Measured: At t0 baseline and t5 10min after end of procedure
STAI-trait
State-Trait Anxiety Inventory - trait section - 20 item. Score range 20-80. Higher score is higher anxiety.
Measured: At t0 baseline
Perceived stress questionnaire
The PSS gives an indication about the feelings and thoughts during the past month of the patient. Score range 0-40. Higher score means higher perceived stress.
Measured: At t0 baseline
Pain during arterial punction
Measured using NRS score, with 0 representing no pain and 10 worst pain imaginable
Measured: At t4 during procedure (directly after arterial access)
Patient satisfaction
Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied
Measured: At t5 10min after end of procedure
Cardiologist satisfaction with procedure
Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied
Measured: At t5 10min after end of procedure
Radial artery spasm yes/no
As reported by cardiologist
Measured: At t5 10min after end of procedure
complexity of procedure
Reported by cardiologist in categories: less complex than anticipated - as anticipated - more complex than anticipated.
Measured: At t5 10min after end of procedure
anxiolytics use
Use of benzodiazepines (yes/no) was registered for each patient
Measured: At t2 20 minutes after t1 right before patients transfers to procedure room and t5 10min after end of procedure
Igroup presence questionnaire
Assesses the presence in the virtual environment, only taken in intervention group.
Measured: t5 10min after end of procedure
Total finished VR sessions
Only taken in intervention group.
Measured: t5 10min after end of procedure
Total duration of VR use
Only taken in intervention group.
Measured: t5 10min after end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start18 Sep 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215456
- Sponsor's protocol ID
- 114869
- Acronym
- VR InCard
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided upon reasonable request
Publications
Breunissen EHW, Groenveld TD, Garms L, Bonnes JL, van Goor H, Damman P. Virtual reality to reduce periprocedural anxiety during invasive coronary angiography: rationale and design of the VR InCard trial. Open Heart. 2024 Apr 2;11(1):e002628. doi: 10.1136/openhrt-2024-002628.
PubMed 38569670
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography: Rationale and Design of the VR InCard Trial
- ClinicalTrials.gov ID
- NCT06215456
- Acronym / sponsor ID
- VR InCard / 114869
- Conditions
- Anxiety, Anxiety State
- Keywords
- Virtual reality therapy, Procedural anxiety, Invasive coronary angiography, nonpharmacological, Anxiolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 22 Jan 2024 (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.
Introduction Patients undergoing invasive coronary angiography experience anxiety due to various factors. This can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. VR is an promising nonpharmacological intervention that can be used to reduce anxiety in patients undergoing an invasive coronary angiography.
Methods and analysis A single-center open-label randomized controlled trial was performed to assess the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing invasive coronary angiography and experiencing anxiety in periprocedural setting. The primary outcome is the NRS anxiety score measured just before obtaining arterial access. Secondary outcomes are physiological measures of anxiety and the State-Trait Anxiety Inventory, Perceived Stress Scale, and IGroup presence questionnaire. The NRS anxiety level and physiological measurements will be taken at five scheduled times between pre procedural, peri and post procedural. The State-Trait Anxiety Inventory and Perceived Stress Scale will be performed prior to coronary angiography and the State-Trait Anxiety Inventory (state form) and the IGroup Presence questionnaire will be performed post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will be treated according to local protocol. Unless contra-indicated, patients experiencing moderate to severe anxiety before undergoing ICA may receive preprocedural oxazepam (10 mg, oral) at the day care unit and diazepam (5 mg, intravenous) before arterial puncture at the catheterization room at nurses and physicians discretion. In patients planned for coronary function testing, benzodiazepines are withheld per protocol. |
| Virtual Reality therapy | Active comparator | Device: Virtual reality therapyThe VR intervention group will receive two sessions of VRH in addition to standard care. Before starting the first guided session in this study, patients can use VR during the waiting time using SyncVR Relax \& Distract (SyncVR Medical, Utrecht, The Netherlands). Subsequently, the first session of VRH is administered at the day-care unit 20 minutes prior to the procedure. After the first session patients is transported to the catheterization room, where the treatment team have the possibility to introduce themselves to the patients. The second session of VRH is administered during arterial access puncture in the catheterization room, starting 5 minutes prior to puncture and terminating when the diagnostic or guiding coronary catheter is in position. The rest of the procedure will be continued without VR. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient ≥16 years undergoing elective cardiac catheterisation
- Patient is willing and able to comply with the study protocol
- NRS anxiety score ≥ 4
Key exclusion criteria (3 listed)
- History of dementia
- Severe hearing/visual impairment not corrected
- Depression or anxiety disorder
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 therapyVR therapy will be applied using a head mounted display, the PICO G2 4K headset (Barcelona, Spain). For VRD de application'SyncVR Relax \& Distract' (SyncVR Medical, Utrecht, The Netherlands) will be used. This application contains a wide range of relaxation games, relaxing 360 videos, and relaxation exercises each with a duration of 5-20 minutes. Patients can choose videos, games, or exercises according to their own preferences. For VRH sessions, the application HypnoVR (Strasbourg, France) will be used. This app contains several hypnotic narratives integrating sequences of controlled breathing, cardiac coherence, and hypnotic suggestions. Each VRH sessions can be personalized through selecting different environments and musical compositions.The first VRH session will be set to last 20 minutes and the second VRH session will be set to the continuous setting. | Device | Virtual Reality therapy |
Primary outcome
NRS anxiety
Time frame: Assessed at established moment right before start op procedure.
Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety imaginable.
19 secondary outcomes
NRS anxiety
Time frame: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
heart rate
Time frame: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
blood pressure
Time frame: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
heart rate variability
Time frame: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
heart rate variability
Time frame: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
heart rate variability
Time frame: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
respiration rate
Time frame: At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure
STAI-state short form
Time frame: At t0 baseline and t5 10min after end of procedure
STAI-trait
Time frame: At t0 baseline
Perceived stress questionnaire
Time frame: At t0 baseline
Pain during arterial punction
Time frame: At t4 during procedure (directly after arterial access)
Patient satisfaction
Time frame: At t5 10min after end of procedure
Cardiologist satisfaction with procedure
Time frame: At t5 10min after end of procedure
Radial artery spasm yes/no
Time frame: At t5 10min after end of procedure
complexity of procedure
Time frame: At t5 10min after end of procedure
anxiolytics use
Time frame: At t2 20 minutes after t1 right before patients transfers to procedure room and t5 10min after end of procedure
Igroup presence questionnaire
Time frame: t5 10min after end of procedure
Total finished VR sessions
Time frame: t5 10min after end of procedure
Total duration of VR use
Time frame: t5 10min after end of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 38569670Breunissen EHW, Groenveld TD, Garms L, Bonnes JL, van Goor H, Damman P. Virtual reality to reduce periprocedural anxiety during invasive coronary angiography: rationale and design of the VR InCard trial. Open Heart. 2024 Apr 2;11(1):e002628. doi: 10.1136/openhrt-2024-002628.
- Individual participant dataSharing planned: Yes. Data will be provided upon reasonable request
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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.
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 therapy in people with Anxiety and Anxiety State, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS anxiety (time frame: Assessed at established moment right before start op procedure.). 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 NCT06215456, which also lists 1 linked publication.
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 11 Apr 2024.