UHW Angiogram Video Project

NCT03957538 | Completed

• 1 other identifier: 17/DEC/7157
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Difference in post procedure satisfaction scores between patients receiving standard care and those who experienced the immersive VR experience

  3 months

Study Arms (2)

Standard care

NO INTERVENTION

Standard consent and explanation

Virtual reality

EXPERIMENTAL

Addition of VR headset

Behavioral: Virtual reality angiogram experience video

Interventions

Virtual reality angiogram experience video BEHAVIORAL

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.

Virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients undergoing their first cardiac catheterisation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Wales: lead

Study Sites (1)

University Hospital of Wales

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sean Gallagher, MBBS

  University Hospital of Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Spr

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: July 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: October 10, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)