Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography

Anxiety Clinical Trial

— VR InCard  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215456
• Other study ID #: 114869
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Anxiety State

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	STAI-trait	State-Trait Anxiety Inventory - trait section - 20 item. Score range 20-80. Higher score is higher anxiety.	At t0 baseline
Secondary	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
Secondary	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)
Secondary	Patient satisfaction	Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied	At t5 10min after end of procedure
Secondary	Cardiologist satisfaction with procedure	Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied	At t5 10min after end of procedure
Secondary	Radial artery spasm yes/no	As reported by cardiologist	At t5 10min after end of procedure
Secondary	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
Secondary	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
Secondary	Igroup presence questionnaire	Assesses the presence in the virtual environment, only taken in intervention group.	t5 10min after end of procedure
Secondary	Total finished VR sessions	Only taken in intervention group.	t5 10min after end of procedure
Secondary	Total duration of VR use	Only taken in intervention group.	t5 10min after end of procedure