- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03677791
Virtual 360°-Tour in Coronary Computed Tomography
Virtual 360°-Tour in Coronary Computed Tomography - Effects of 360° Virtual Counselling Environment in CCTA Patient's Anxiety and Process Time
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Oulu, Finland
- Oulu University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- coming to first coronary computed tomography examination
- adult patient
- able to independently fill in question forms
Exclusion Criteria:
- previous coronary computed tomography
- mental illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual 360° intervention
counselling in the virtual 360° environment and also counselling in accordance with current practice
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Virtual tour in coronary computed tomography - 360° counselling environment for CCTA patients
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Active Comparator: Control group
counselling in accordance with current practice
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counselling in accordance with current practice: written patient information letter and verbal counselling at the hospital during the CT-examination
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CCTA Process time
Time Frame: 1 month
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Time between patient enrolled to the CCTA at the hospital and when radiographers marked the cCTA examination ended
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1 month
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KPP12345
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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