Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography (VR InCard)

Radboud University Medical Center

Status: Enrolling

Conditions: Anxiety; Anxiety State

Treatments: Device: Virtual reality therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06215456

114869

Details and patient eligibility

About

Introduction Patients undergoing invasive coronary angiography experience anxiety due to various factors. This can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. VR is an promising nonpharmacological intervention that can be used to reduce anxiety in patients undergoing an invasive coronary angiography.

Methods and analysis A single-center open-label randomized controlled trial was performed to assess the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing invasive coronary angiography and experiencing anxiety in periprocedural setting. The primary outcome is the NRS anxiety score measured just before obtaining arterial access. Secondary outcomes are physiological measures of anxiety and the State-Trait Anxiety Inventory, Perceived Stress Scale, and IGroup presence questionnaire. The NRS anxiety level and physiological measurements will be taken at five scheduled times between pre procedural, peri and post procedural. The State-Trait Anxiety Inventory and Perceived Stress Scale will be performed prior to coronary angiography and the State-Trait Anxiety Inventory (state form) and the IGroup Presence questionnaire will be performed post-intervention.

Enrollment: 100 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥16 years undergoing elective cardiac catheterisation
• Patient is willing and able to comply with the study protocol
• NRS anxiety score ≥ 4

Exclusion criteria

• History of dementia
• Severe hearing/visual impairment not corrected
• Depression or anxiety disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will be treated according to local protocol. Unless contra-indicated, patients experiencing moderate to severe anxiety before undergoing ICA may receive preprocedural oxazepam (10 mg, oral) at the day care unit and diazepam (5 mg, intravenous) before arterial puncture at the catheterization room at nurses and physicians discretion. In patients planned for coronary function testing, benzodiazepines are withheld per protocol.

Virtual Reality therapy

Active Comparator group

Description:

The VR intervention group will receive two sessions of VRH in addition to standard care. Before starting the first guided session in this study, patients can use VR during the waiting time using SyncVR Relax \& Distract (SyncVR Medical, Utrecht, The Netherlands). Subsequently, the first session of VRH is administered at the day-care unit 20 minutes prior to the procedure. After the first session patients is transported to the catheterization room, where the treatment team have the possibility to introduce themselves to the patients. The second session of VRH is administered during arterial access puncture in the catheterization room, starting 5 minutes prior to puncture and terminating when the diagnostic or guiding coronary catheter is in position. The rest of the procedure will be continued without VR.

Treatment:

Device: Virtual reality therapy