The goal of this prospective pilot study is to learn if the use of virtual reality and/or relaxing soundscapes can help lower anxiety in adult patients undergoing a scheduled coronary angiography or angioplasty as compared to the standard of care. The main questions it aims to answer are: * The use of non-pharmacological strategies reduces intraprocedural stress and anxiety compared to standard of care * Reducing anxiety limits the use of pharmacological agents, which increases patient safety. Researchers will compare the use of relaxing soundscapes or virtual reality to the standard of care to see the effects of these strategies on pain, anxiety and stress. Participants will: * listen to relaxing soundscapes, OR experience virtual reality including soundscapes OR standard of care during their procedure, * Answer pain, anxiety and recovery questionnaires, * Answer satisfaction questionnaires.
The EASY-HD project is a prospective, randomized, controlled pilot study to evaluate the effectiveness of immersive nonpharmacological strategies, soundscapes, and virtual reality (VR) on the reduction of intraprocedural anxiety and stress in patients undergoing a scheduled hemodynamic intervention (coronary angiography and/or angioplasty). Adult patients will be included and randomized into three parallel groups (1:1:1): standard of care alone (control group), standard of care combined with relaxing soundscapes via headphones, or standard of care combined with virtual reality immersion in a soothing environment including sound. The devices will be set up 5 to 10 minutes before the procedure and continued througout. This minimal-risk study aims to determine the feasibility and potential clinical benefit of these simple, reproducible non-pharmacological approaches to improve patient comfort and possibly reduce the need for hemodynamic sedation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Auditive distraction therapy
Virtual reality-lead audiovisual experience
IUCPQ
Québec, Quebec, Canada
Change in patient-reported anxiety
Change from baseline in patient reported anxiety evaluated by anxiety questionnaires Visual Analog Score for anxiety (0 = Not anxious at all - 10 = Extremely anxious)
Time frame: Baseline (preprocedural), periprocedural and at one-week follow-up
Change in patient-reported anxiety
Change from baseline in patient reported anxiety evaluated by anxiety questionnaires State-Trait Anxiety Invetory for Adults - 6 item short form
Time frame: Baseline, Periprocedural, and at one-week follow-up
Change in patient-reported pain
Change from baseline in patient reported pain evaluated by pain questionnaires Visual Analog Scale for pain (0=No pain - 10 = Worst pain possible)
Time frame: Baseline, periprocedural and at one-week follow-up
Use of analgesic and anxiolytic medications
Use vs no-use of analgesic (opioid/non-opioid) and/or anxiolytic medication. If analgesic and/or anxiolytic medication is used, its type, dose and frequency will be registered.
Time frame: Within 48 hours before and after the procedure
Change from baseline in physiological factors associated with pain and anxiety - Heart Rate
Heart rate (beats per minute)
Time frame: Baseline, periprocedural
Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate
Respiratory rate (breaths per minute)
Time frame: Baseline, periprocedural
Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure
Blood pressure (mmHg)
Time frame: Baseline, Periprocedural
Incidence of adverse events of interest
Patient-reported nausea, dizziness and increased anxiety will be collected
Time frame: Within 10 days of the procedure
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