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UHW Angiogram Video Project (VIRTUAL CATH)

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual reality angiogram experience video
Sponsored by
University Hospital of Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- All patients undergoing their first cardiac catheterisation

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital of Wales

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Virtual reality

Arm Description

Standard consent and explanation

Addition of VR headset

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2019
Last Updated
April 26, 2021
Sponsor
University Hospital of Wales
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1. Study Identification

Unique Protocol Identification Number
NCT03957538
Brief Title
UHW Angiogram Video Project
Acronym
VIRTUAL CATH
Official Title
The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels in Patients Undergoing CArdiac caTHeterisation: The VIRTUAL CATH Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
October 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Wales

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard consent and explanation
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Addition of VR headset
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality angiogram experience video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in pre and post procedural anxiety scores between patients receiving standard care and those who experienced the immersive VR experience
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Difference in post procedure satisfaction scores between patients receiving standard care and those who experienced the immersive VR experience
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - All patients undergoing their first cardiac catheterisation Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Gallagher, MBBS
Organizational Affiliation
University Hospital of Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

UHW Angiogram Video Project

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