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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard of care analgesic and anxiolytic therapy | |
| Auditive experience | Experimental | 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). |
|
| Immersion experience | Experimental | A pre-defined virtual-reality led audiovisual experience will be used along standard of care pain and anxiety-relief medication (on patient's demand). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditive experience | Other | Auditive distraction therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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) | Baseline, periprocedural and at one-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 48 hours before and after the procedure |
| Change from baseline in physiological factors associated with pain and anxiety - Heart Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse cardiac events | Within 10 days of the procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Jadin | Contact | 4186568711 | michele.jadin@criucpq.ulaval.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUCPQ | Québec | Quebec | G1V 4G5 | Canada |
|
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| Audiovisual immersive experience |
| Other |
Virtual reality-lead audiovisual experience |
|
Heart rate (beats per minute) |
| Baseline, periprocedural |
| Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate | Respiratory rate (breaths per minute) | Baseline, periprocedural |
| Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure | Blood pressure (mmHg) | Baseline, Periprocedural |
| Incidence of adverse events of interest | Patient-reported nausea, dizziness and increased anxiety will be collected | Within 10 days of the procedure |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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