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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Anxiety State
• Intervention / Treatment: Device: Virtual reality therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Recruiting
      • Radboud University Medical Center
      • Contact: Groenveld, MD; Email: tjitske.groenveld@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Active Comparator: Virtual Reality therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS anxiety	Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst 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	Both systolic and diastolic blood pressure will be measured	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	LF/HF ratio are extracted	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	RMSSD (root mean square of the successive differences) is extracted	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	SDNN (standard deviation of the NN (R-R) intervals) is extracted	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
respiration 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
STAI-state short form	State-Trait Anxiety Inventory - state section - 6 item. Score range 6-24. Higher score is higher anxiety.	At t0 baseline and t5 10min after end of procedure
STAI-trait	State-Trait Anxiety Inventory - trait section - 20 item. Score range 20-80. Higher score is higher anxiety.	At t0 baseline
Perceived stress questionnaire	The PSS gives an indication about the feelings and thoughts during the past month of the patient. Score range 0-40. Higher score means higher perceived stress.	At t0 baseline
Pain during arterial punction	Measured using NRS score, with 0 representing no pain and 10 worst pain imaginable	At t4 during procedure (directly after arterial access)
Patient satisfaction	Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied	At t5 10min after end of procedure
Cardiologist satisfaction with procedure	Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied	At t5 10min after end of procedure
Radial artery spasm yes/no	As reported by cardiologist	At t5 10min after end of procedure
complexity of procedure	Reported by cardiologist in categories: less complex than anticipated - as anticipated - more complex than anticipated.	At t5 10min after end of procedure
anxiolytics use	Use of benzodiazepines (yes/no) was registered for each patient	At t2 20 minutes after t1 right before patients transfers to procedure room and t5 10min after end of procedure
Igroup presence questionnaire	Assesses the presence in the virtual environment, only taken in intervention group.	t5 10min after end of procedure
Total finished VR sessions	Only taken in intervention group.	t5 10min after end of procedure
Total duration of VR use	Only taken in intervention group.	t5 10min after end of procedure

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: nonpharmacological; Invasive coronary angiography; Anxiolysis; Procedural anxiety; Virtual reality therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 114869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be provided upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No