AnxietyVIRTUAL CATHNCT03957538
UHW Angiogram Video Project
A study testing Virtual reality angiogram experience video in people with Anxiety, run by University Hospital of Wales at 1 site in United Kingdom.
Trial summary
This study is a randomised control trial which aims to assess whether the use of an immersive virtual reality angiogram experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual reality angiogram experience video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 10 Oct 2020
- 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
- All patients undergoing their first cardiac catheterisation
Who cannot join
- Patients who cannot comprehend English or Welsh
- Those who have significant visual or auditory impairment meaning they would be unable to fully appreciate the video material
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels in Patients Undergoing CArdiac caTHeterisation: The VIRTUAL CATH Trial
This study is a randomised control trial which aims to assess whether the use of an immersive virtual reality angiogram experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation.
Read the detailed description
Patients undergoing cardiac catheterisation are understandably anxious. This is due to a lack of familiarity with both the hospital environment and the planned procedure. Anxiety may negatively affect their patient experience. Appropriate patient information can help improve understanding and reduce anxiety. In particular, video-based patient information prior to cardiac catheterisation has been shown to improve patient's knowledge and reduce peri-procedural anxiety. Generic video-based patient information about the cardiac catheterisation procedure is widely available. Ideally any patient information delivered pre-cardiac catheterization would be specific to the hospital delivering care. The use of virtual reality (VR) in healthcare is novel, but expanding rapidly. The immersive nature of VR allows patients a unique opportunity to prepare for the procedure and environment within which they will be treated. To date, the use of VR to prepare patients for invasive cardiac procedures has not been studied.
The aim of this study is to assess whether the use of an immersive VR experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation. The investigators will also assess whether the VR experience improves overall patient satisfaction.
With the help of a local media company, a VR cardiac catheterisation video was produced (Figure 1 depicts a screenshot from the VR video). The video is watched with a VR headset to create a 360 immersive experience. The investigators are undertaking a single-centre randomised control trial comparing the use of an immersive VR experience 1 week prior to catheterisation with standard pre-procedural care. Pre procedural anxiety levels and procedural knowledge are assessed by questionnaire, using the validated six-item short-form of the Strait Trait Anxiety Inventory (STAI). A satisfaction questionnaire is also completed before the patient is discharged.
- Conditions
- Anxiety
- Being tested
- Virtual reality angiogram experience video
- 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 angiogram experience videoBehavioural
The VR video is watched via the VR headset, and describes the pre- procedural and procedural experience. Concurrent audio will be provided through earplugs to compete the patients' immersive experience. The video was written and directed by the team, and care has been taken to ensure that the same procedural information is contained within both the British Heart Foundation cardiac catheterisation video and of VR immersive video. Filming was performed within the cardiac catheterisation labs at our tertiary centre using the professional services of Orchard Media (Cardiff, UK). The investigators utilized real physicians and nurses to re-enact a typical day for a mock patient undergoing an uncomplicated procedure. There is also a short explanation of the procedure and animations explaining technical aspects of the procedure contained within the VR video.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Standard consent and explanation |
| Virtual reality | Experimental | Addition of VR headset Receives: Behavioral: Virtual reality angiogram experience video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pre and post procedural anxiety scores between patients receiving standard care and those who experienced the immersive VR experience
Study data collection will be via questionnaire, including the validated six-item short-form of the Strait Trait Anxiety Inventory (STAI). The STAI is a well-established and validated measure of anxiety that can be used in various clinical settings. The investigators chose the STAI as the primary outcome measure as it has been validated as a measure of anxiety in patients undergoing invasive cardiac procedures. Total score available is 32, minimum score 8. The higher the score the higher the anxiety.
Measured: 3 months
Secondary outcomes (1)
Difference in post procedure satisfaction scores between patients receiving standard care and those who experienced the immersive VR experience
After cardiac catheterisation study patients will be asked to complete a satisfaction questionnaire. This is a modification of an accepted and validated post cardiac catheterisation patient satisfaction questionnaire. Total score available 60. Minimum score 6. Higher score indicates better satisfaction.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Jul 2019
- Primary completion1 Aug 2020
- Study completion10 Oct 2020
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Morgan, University Hospital of Wales
- Investigators
- Sean Gallagher, MBBS, Principal investigator, University Hospital of Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957538
- Sponsor's protocol ID
- 17/DEC/7157
- Acronym
- VIRTUAL CATH
- Status last verified
- Apr 2021
- First submitted
- 17 May 2019
- Last updated
- 28 Apr 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels in Patients Undergoing CArdiac caTHeterisation: The VIRTUAL CATH Trial
- ClinicalTrials.gov ID
- NCT03957538
- Acronym / sponsor ID
- VIRTUAL CATH / 17/DEC/7157
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital of WalesUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 21 May 2019 (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.
This study is a randomised control trial which aims to assess whether the use of an immersive virtual reality angiogram experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation.
Detailed description
Patients undergoing cardiac catheterisation are understandably anxious. This is due to a lack of familiarity with both the hospital environment and the planned procedure. Anxiety may negatively affect their patient experience. Appropriate patient information can help improve understanding and reduce anxiety. In particular, video-based patient information prior to cardiac catheterisation has been shown to improve patient's knowledge and reduce peri-procedural anxiety. Generic video-based patient information about the cardiac catheterisation procedure is widely available. Ideally any patient information delivered pre-cardiac catheterization would be specific to the hospital delivering care. The use of virtual reality (VR) in healthcare is novel, but expanding rapidly. The immersive nature of VR allows patients a unique opportunity to prepare for the procedure and environment within which they will be treated. To date, the use of VR to prepare patients for invasive cardiac procedures has not been studied.
The aim of this study is to assess whether the use of an immersive VR experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation. The investigators will also assess whether the VR experience improves overall patient satisfaction.
With the help of a local media company, a VR cardiac catheterisation video was produced (Figure 1 depicts a screenshot from the VR video). The video is watched with a VR headset to create a 360 immersive experience. The investigators are undertaking a single-centre randomised control trial comparing the use of an immersive VR experience 1 week prior to catheterisation with standard pre-procedural care. Pre procedural anxiety levels and procedural knowledge are assessed by questionnaire, using the validated six-item short-form of the Strait Trait Anxiety Inventory (STAI). A satisfaction questionnaire is also completed before the patient is discharged.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Standard consent and explanation |
| Virtual reality | Experimental | Behavioral: Virtual reality angiogram experience videoAddition of VR headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing their first cardiac catheterisation
Key exclusion criteria (2 listed)
- Patients who cannot comprehend English or Welsh
- Those who have significant visual or auditory impairment meaning they would be unable to fully appreciate the video material
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 angiogram experience videoThe VR video is watched via the VR headset, and describes the pre- procedural and procedural experience. Concurrent audio will be provided through earplugs to compete the patients' immersive experience. The video was written and directed by the team, and care has been taken to ensure that the same procedural information is contained within both the British Heart Foundation cardiac catheterisation video and of VR immersive video. Filming was performed within the cardiac catheterisation labs at our tertiary centre using the professional services of Orchard Media (Cardiff, UK). The investigators utilized real physicians and nurses to re-enact a typical day for a mock patient undergoing an uncomplicated procedure. There is also a short explanation of the procedure and animations explaining technical aspects of the procedure contained within the VR video. | Behavioural | Virtual reality |
Primary outcome
Difference in pre and post procedural anxiety scores between patients receiving standard care and those who experienced the immersive VR experience
Time frame: 3 months
Study data collection will be via questionnaire, including the validated six-item short-form of the Strait Trait Anxiety Inventory (STAI). The STAI is a well-established and validated measure of anxiety that can be used in various clinical settings. The investigators chose the STAI as the primary outcome measure as it has been validated as a measure of anxiety in patients undergoing invasive cardiac procedures. Total score available is 32, minimum score 8. The higher the score the higher the anxiety.
1 secondary outcome
Difference in post procedure satisfaction scores between patients receiving standard care and those who experienced the immersive VR experience
Time frame: 3 months
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 28 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Recruiting
TOUCHminds: Help-seeking in Adolescents With Anxiety
Anxiety Symptoms, Anxiety Disorders
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
AI-Based CBT Chatbot for Adolescent Social Anxiety
AI-CBT Intervention Group, Waitlist Control Group
Not yet recruitingObservational study
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
ANXIETY
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
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.
Sean Gallagher, MBBS principal investigator
University Hospital of Wales
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 angiogram experience video in people with Anxiety, run by University Hospital of Wales at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 28 Apr 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 Kingdom. 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?
Difference in pre and post procedural anxiety scores between patients receiving standard care and those who experienced the immersive VR experience (time frame: 3 months). 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 28 Apr 2021.