Coronary Artery DiseaseNCT03677791
Virtual 360°-Tour in Coronary Computed Tomography
A study testing Virtual tour in coronary computed tomography - 360° counselling environment and Current practice in people with Coronary Artery Disease and Anxiety, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and process time of the patients coming to CCTA (coronary computed tomography angiography). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Anxiety, Fear
- What is being tested?
- Virtual tour in coronary computed tomography - 360° counselling environment and Current practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFinland
- Study dates
- 17 Jun 2020to 15 May 2022
- 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
- coming to first coronary computed tomography examination
- adult patient
- able to independently fill in question forms
Who cannot join
- previous coronary computed tomography
- mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual 360°-Tour in Coronary Computed Tomography - Effects of 360° Virtual Counselling Environment in CCTA Patient's Anxiety and Process Time
The purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and process time of the patients coming to CCTA (coronary computed tomography angiography). The virtual, 360° environment 'Virtual 360°-tour in coronary computed tomography' uses 360°- technology based on spherical panorama images and resembles the spaces of the hospital according to the patient's pathway in CT-examination and provides information to the patient at various stages of the pathway.
Read the detailed description
The purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and process time of the patients coming to CCTA (coronary computed tomography angiography).
The virtual, 360° environment 'Virtual 360°-tour in coronary computed tomography' uses 360°- technology based on spherical panorama images and resembles the spaces of the hospital according to the patient's pathway in CT-examination and provides information to the patient at various stages of the pathway. Patients who have referred first time to the coronary computed tomography can access the virtual CT examination environment via link before entering the hospital. Using the environment requires a network connection and is possible with a computer, tablet or phone. The environment has digital counselling materials in text, image, animation and video formats in three different virtual spaces/views, the environment and examination are presented via pathway of example 59-year female patient with arterial hypertension and exercise related chest pain (angina pectoris).
- Conditions
- Coronary Artery Disease, Anxiety, Fear
- Being tested
- Virtual tour in coronary computed tomography - 360° counselling environment, Current practice
- Keywords
- counselling, computed tomography, coronary, CT, virtual, 360, anxiety
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual tour in coronary computed tomography - 360° counselling environmentOther
Virtual tour in coronary computed tomography - 360° counselling environment for CCTA patients
Current practiceOther
counselling in accordance with current practice: written patient information letter and verbal counselling at the hospital during the CT-examination
| Study group | Role | What they receive |
|---|---|---|
| Virtual 360° intervention | Experimental | counselling in the virtual 360° environment and also counselling in accordance with current practice Receives: Other: Virtual tour in coronary computed tomography - 360° counselling environment |
| Control group | Active comparator | counselling in accordance with current practice Receives: Other: Current practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety measured with State-Trait Anxiety Inventory for adults (STAI)
The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberger and his research team (1983). It separates situation related anxiety (STATE-A) from character related tendency towards anxiety (TRAIT-A). User evaluates his own current anxiety on a four-step scale with forty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety. Scores range from 20 to 80: mild anxiety 20-39 points, moderate anxiety 40-59 points and strong anxiety 60-80 points.
Measured: 1 month
Secondary outcomes (1)
CCTA Process time
Time between patient enrolled to the CCTA at the hospital and when radiographers marked the cCTA examination ended
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start17 Jun 2020
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT (Randomized controlled trial)
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677791
- Sponsor's protocol ID
- KPP12345
- Status last verified
- Jun 2022
- First submitted
- 14 Sep 2018
- Last updated
- 6 Jun 2022
- Results posted
- 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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual 360°-Tour in Coronary Computed Tomography - Effects of 360° Virtual Counselling Environment in CCTA Patient's Anxiety and Process Time
- ClinicalTrials.gov ID
- NCT03677791
- Acronym / sponsor ID
- KPP12345
- Conditions
- Coronary Artery Disease, Anxiety, Fear
- Keywords
- counselling, computed tomography, coronary, CT, virtual, 360, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 19 Sep 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 purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and process time of the patients coming to CCTA (coronary computed tomography angiography). The virtual, 360° environment 'Virtual 360°-tour in coronary computed tomography' uses 360°- technology based on spherical panorama images and resembles the spaces of the hospital according to the patient's pathway in CT-examination and provides information to the patient at various stages of the pathway.
Detailed description
The purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and process time of the patients coming to CCTA (coronary computed tomography angiography).
The virtual, 360° environment 'Virtual 360°-tour in coronary computed tomography' uses 360°- technology based on spherical panorama images and resembles the spaces of the hospital according to the patient's pathway in CT-examination and provides information to the patient at various stages of the pathway. Patients who have referred first time to the coronary computed tomography can access the virtual CT examination environment via link before entering the hospital. Using the environment requires a network connection and is possible with a computer, tablet or phone. The environment has digital counselling materials in text, image, animation and video formats in three different virtual spaces/views, the environment and examination are presented via pathway of example 59-year female patient with arterial hypertension and exercise related chest pain (angina pectoris).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- RCT (Randomized controlled trial)
| Arm | Type | Receives |
|---|---|---|
| Virtual 360° intervention | Experimental | Other: Virtual tour in coronary computed tomography - 360° counselling environmentcounselling in the virtual 360° environment and also counselling in accordance with current practice |
| Control group | Active comparator | Other: Current practicecounselling in accordance with current practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- coming to first coronary computed tomography examination
- adult patient
- able to independently fill in question forms
Key exclusion criteria (2 listed)
- previous coronary computed tomography
- mental illness
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 tour in coronary computed tomography - 360° counselling environmentVirtual tour in coronary computed tomography - 360° counselling environment for CCTA patients | Other | Virtual 360° intervention |
| Current practicecounselling in accordance with current practice: written patient information letter and verbal counselling at the hospital during the CT-examination | Other | Control group |
Primary outcome
anxiety measured with State-Trait Anxiety Inventory for adults (STAI)
Time frame: 1 month
The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberger and his research team (1983). It separates situation related anxiety (STATE-A) from character related tendency towards anxiety (TRAIT-A). User evaluates his own current anxiety on a four-step scale with forty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety. Scores range from 20 to 80: mild anxiety 20-39 points, moderate anxiety 40-59 points and strong anxiety 60-80 points.
1 secondary outcome
CCTA Process time
Time frame: 1 month
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 6 Jun 2022.
- Patients', radiographers' and radiography students' experiences of 360° virtual counselling environment for the coronary computed tomography angiography: A qualitative studyLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 tour in coronary computed tomography - 360° counselling environment and Current practice in people with Coronary Artery Disease and Anxiety, run by University of Oulu at 1 site in Finland.
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 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 6 Jun 2022. 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 Finland. 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?
anxiety measured with State-Trait Anxiety Inventory for adults (STAI) (time frame: 1 month). 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 6 Jun 2022.