Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography

NCT06215456 | Unknown

• 1 other identifier: 114869
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Virtual reality therapy; Procedural anxiety; Invasive coronary angiography; nonpharmacological; Anxiolysis

Outcome Measures

Primary Outcomes (1)

• NRS anxiety

  Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety imaginable.

  Assessed at established moment right before start op procedure.

Secondary Outcomes (19)

• NRS anxiety

  At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure

• heart rate

  At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure

• blood pressure

  At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure

• heart rate variability

  At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure

• heart rate variability

  At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure

Study Arms (2)

Control

NO INTERVENTION

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

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.

Device: Virtual reality therapy

Interventions

Virtual reality therapy DEVICE

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.

Virtual Reality therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Related Publications (1)

• Breunissen EHW, Groenveld TD, Garms L, Bonnes JL, van Goor H, Damman P. Virtual reality to reduce periprocedural anxiety during invasive coronary angiography: rationale and design of the VR InCard trial. Open Heart. 2024 Apr 2;11(1):e002628. doi: 10.1136/openhrt-2024-002628.

  PMID: 38569670 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 22, 2024
• Study Start: September 18, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)