An interventional study of Auditive experience and Audiovisual immersive experience in Cardiovascular Disease, Cardiovascular Care and Pain and Anxiety During Cardiac Catheterization, sponsored by Olivier F. Bertrand. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Olivier F. Bertrand · Not applicable, Interventional, and Supportive care
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:
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:
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Olivier F. Bertrand is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of care analgesic and anxiolytic therapy
A pre-defined non-invasive audio experience using relaxing soundscapes via headphones will be used along standard of care pain and anxiety-relief medication (on patient's demand).
Other: Auditive experience
A pre-defined virtual-reality led audiovisual experience will be used along standard of care pain and anxiety-relief medication (on patient's demand).
Other: Audiovisual immersive experience
Auditive distraction therapy
Virtual reality-lead audiovisual experience
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
Incidence of adverse cardiac events
Time frame: Within 10 days of the procedure
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Olivier F. Bertrand