Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography
- Conditions
- Anxiety StateAnxiety
- Registration Number
- NCT06215456
- Lead Sponsor
- Radboud University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Patient ≥16 years undergoing elective cardiac catheterisation
- Patient is willing and able to comply with the study protocol
- NRS anxiety score ≥ 4
- History of dementia
- Severe hearing/visual impairment not corrected
- Depression or anxiety disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method NRS anxiety Assessed at established moment right before start op procedure. Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety imaginable.
- Secondary Outcome Measures
Name Time Method Total finished VR sessions t5 10min after end of procedure Only taken in intervention group.
anxiolytics use At t2 20 minutes after t1 right before patients transfers to procedure room and t5 10min after end of procedure Use of benzodiazepines (yes/no) was registered for each patient
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 Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety
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 Both systolic and diastolic blood pressure will be measured
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 SDNN (standard deviation of the NN (R-R) intervals) is extracted
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 Igroup presence questionnaire t5 10min after end of procedure Assesses the presence in the virtual environment, only taken in intervention group.
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 STAI-trait At t0 baseline State-Trait Anxiety Inventory - trait section - 20 item. Score range 20-80. Higher score is higher anxiety.
Patient satisfaction At t5 10min after end of procedure Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied
complexity of procedure At t5 10min after end of procedure Reported by cardiologist in categories: less complex than anticipated - as anticipated - more complex than anticipated.
STAI-state short form At t0 baseline and t5 10min after end of procedure State-Trait Anxiety Inventory - state section - 6 item. Score range 6-24. Higher score is higher anxiety.
Perceived stress questionnaire At t0 baseline 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.
Pain during arterial punction At t4 during procedure (directly after arterial access) Measured using NRS score, with 0 representing no pain and 10 worst pain imaginable
Cardiologist satisfaction with procedure At t5 10min after end of procedure Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied
Radial artery spasm yes/no At t5 10min after end of procedure As reported by cardiologist
Total duration of VR use t5 10min after end of procedure Only taken in intervention group.
Trial Locations
- Locations (1)
Radboud university medical center
🇳🇱Nijmegen, Gelderland, Netherlands
Radboud university medical center🇳🇱Nijmegen, Gelderland, NetherlandsGroenveld, MDContacttjitske.groenveld@radboudumc.nl