Anxiety Clinical Trial
— VR InCardOfficial title:
Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography: Rationale and Design of the VR InCard Trial
Verified date | December 2023 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud university medical center | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
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 |
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