NCT03677791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 17, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

September 14, 2018

Last Update Submit

June 1, 2022

Conditions

Keywords

counsellingcomputed tomographycoronaryCTvirtual360anxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (1)

  • CCTA Process time

    1 month

Study Arms (2)

Virtual 360° intervention

EXPERIMENTAL

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

Other: Virtual tour in coronary computed tomography - 360° counselling environment

Control group

ACTIVE COMPARATOR

counselling in accordance with current practice

Other: Current practice

Interventions

Virtual tour in coronary computed tomography - 360° counselling environment for CCTA patients

Virtual 360° intervention

counselling in accordance with current practice: written patient information letter and verbal counselling at the hospital during the CT-examination

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coming to first coronary computed tomography examination
  • adult patient
  • able to independently fill in question forms

You may not qualify if:

  • previous coronary computed tomography
  • mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseAnxiety Disorders

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: RCT (Randomized controlled trial)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 19, 2018

Study Start

June 17, 2020

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

June 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations