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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Radboud university medical center
Nijmegen, Gelderland, Netherlands
RECRUITINGNRS anxiety
Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety imaginable.
Time frame: Assessed at established moment right before start op procedure.
NRS anxiety
Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At t0 baseline
Pain during arterial punction
Measured using NRS score, with 0 representing no pain and 10 worst pain imaginable
Time frame: At t4 during procedure (directly after arterial access)
Patient satisfaction
Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied
Time frame: At t5 10min after end of procedure
Cardiologist satisfaction with procedure
Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied
Time frame: At t5 10min after end of procedure
Radial artery spasm yes/no
As reported by cardiologist
Time frame: 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.
Time frame: At t5 10min after end of procedure
anxiolytics use
Use of benzodiazepines (yes/no) was registered for each patient
Time frame: 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.
Time frame: t5 10min after end of procedure
Total finished VR sessions
Only taken in intervention group.
Time frame: t5 10min after end of procedure
Total duration of VR use
Only taken in intervention group.
Time frame: t5 10min after end of procedure
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