Clinical trial NCT06215456: Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography
Official title: Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography: Rationale and Design of the VR InCard Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Anxiety State
Keywords: Virtual reality therapy
Procedural anxiety
Invasive coronary angiography
nonpharmacological
Anxiolysis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: NRS anxiety
timeFrame: Assessed at established moment right before start op procedure.
Secondary outcomes:
measure: NRS anxiety
timeFrame: 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
measure: heart rate
timeFrame: 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
measure: blood pressure
timeFrame: 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
measure: heart rate variability
timeFrame: 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
measure: heart rate variability
timeFrame: 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
measure: heart rate variability
timeFrame: 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
measure: respiration rate
timeFrame: 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
measure: STAI-state short form
timeFrame: At t0 baseline and t5 10min after end of procedure
measure: STAI-trait
timeFrame: At t0 baseline
measure: Perceived stress questionnaire
timeFrame: At t0 baseline
measure: Pain during arterial punction
timeFrame: At t4 during procedure (directly after arterial access)
measure: Patient satisfaction
timeFrame: At t5 10min after end of procedure
measure: Cardiologist satisfaction with procedure
timeFrame: At t5 10min after end of procedure
measure: Radial artery spasm yes/no
timeFrame: At t5 10min after end of procedure
measure: complexity of procedure
timeFrame: At t5 10min after end of procedure
measure: anxiolytics use
timeFrame: At t2 20 minutes after t1 right before patients transfers to procedure room and t5 10min after end of procedure
measure: Igroup presence questionnaire
timeFrame: t5 10min after end of procedure
measure: Total finished VR sessions
timeFrame: t5 10min after end of procedure
measure: Total duration of VR use
timeFrame: t5 10min after end of procedure
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References: