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Virtual 360°-Tour in Coronary Computed Tomography

Primary Purpose

Coronary Artery Disease, Anxiety, Fear

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Virtual tour in coronary computed tomography - 360° counselling environment
Current practice
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring counselling, computed tomography, coronary, CT, virtual, 360, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual 360° intervention

Control group

Arm Description

counselling in the virtual 360° environment and also counselling in accordance with current practice

counselling in accordance with current practice

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

CCTA Process time
Time between patient enrolled to the CCTA at the hospital and when radiographers marked the cCTA examination ended

Full Information

First Posted
September 14, 2018
Last Updated
June 1, 2022
Sponsor
University of Oulu
Collaborators
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03677791
Brief Title
Virtual 360°-Tour in Coronary Computed Tomography
Official Title
Virtual 360°-Tour in Coronary Computed Tomography - Effects of 360° Virtual Counselling Environment in CCTA Patient's Anxiety and Process Time
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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). 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Anxiety, Fear
Keywords
counselling, computed tomography, coronary, CT, virtual, 360, anxiety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT (Randomized controlled trial)
Masking
Care Provider
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual 360° intervention
Arm Type
Experimental
Arm Description
counselling in the virtual 360° environment and also counselling in accordance with current practice
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
counselling in accordance with current practice
Intervention Type
Other
Intervention Name(s)
Virtual tour in coronary computed tomography - 360° counselling environment
Intervention Description
Virtual tour in coronary computed tomography - 360° counselling environment for CCTA patients
Intervention Type
Other
Intervention Name(s)
Current practice
Intervention Description
counselling in accordance with current practice: written patient information letter and verbal counselling at the hospital during the CT-examination
Primary Outcome Measure Information:
Title
anxiety measured with State-Trait Anxiety Inventory for adults (STAI)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
CCTA Process time
Description
Time between patient enrolled to the CCTA at the hospital and when radiographers marked the cCTA examination ended
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://doi.org/10.1016/j.radi.2020.09.019
Description
Patients', radiographers' and radiography students' experiences of 360° virtual counselling environment for the coronary computed tomography angiography: A qualitative study

Learn more about this trial

Virtual 360°-Tour in Coronary Computed Tomography

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