UHW Angiogram Video Project

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Virtual reality angiogram experience video

• Registration Number: NCT03957538
• Lead Sponsor: University Hospital of Wales

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.

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Study Start: 2019-07-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-10-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	Virtual reality angiogram experience video	Addition of VR headset

Primary Outcome Measures

Name	Time	Method
Difference in pre and post procedural anxiety scores between patients receiving standard care and those who experienced the immersive VR experience	3 months	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

Name	Time	Method
Difference in post procedure satisfaction scores between patients receiving standard care and those who experienced the immersive VR experience	3 months	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.

Trial Locations

Locations (1)

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom