NCT06215456

Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography

Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography: Rationale and Design of the VR InCard Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anxiety
• Anxiety State

Interventions

Type	Name	Description
DEVICE	Virtual reality therapy	VR therapy will be applied using a head mounted display, the PICO G2 4K headset (Barcelona, Spain). For VRD de application'SyncVR Relax \& Distract' (SyncVR Medical, Utrecht, The Netherlands) will be used. This application contains a wide range of relaxation games, relaxing 360 videos, and relaxation exercises each with a duration of 5-20 minutes. Patients can choose videos, games, or exercises according to their own preferences. For VRH sessions, the application HypnoVR (Strasbourg, France) will be used. This app contains several hypnotic narratives integrating sequences of controlled breathing, cardiac coherence, and hypnotic suggestions. Each VRH sessions can be personalized through selecting different environments and musical compositions.The first VRH session will be set to last 20 minutes and the second VRH session will be set to the continuous setting.

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2024-01-22
• Last updated: 2024-04-11

Locations

1 site across 1 country: Netherlands