Cardiovascular Care, Cardiovascular Disease, Pain and Anxiety During Cardiac Catheterization
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERAuditive experience
Auditive distraction therapy
OTHERAudiovisual immersive experience
Virtual reality-lead audiovisual experience
Sponsors
Olivier F. Bertrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults, 18 years or older * Scheduled hemodynamic intervention (coronary angiography and/or angioplasty) * Patient willing and able to understand the study * Signed informed consent
Exclusion criteria
* Scheduled complex procedure (CTO, structural) * Severe cognitive or psychiatric disorders * Major hearing/visual impairment * Severe motion sickness or history of malaise with Virtual Reality (VR) * Complaints of nausea or vomiting * History of epilepsy * Claustrophobia * Facial injuries * In clinical isolation (infection control)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported anxiety | Baseline (preprocedural), periprocedural and at one-week follow-up | Change from baseline in patient reported anxiety evaluated by anxiety questionnaires Visual Analog Score for anxiety (0 = Not anxious at all - 10 = Extremely anxious) |
| Change in patient-reported pain | Baseline, periprocedural and at one-week follow-up | Change from baseline in patient reported pain evaluated by pain questionnaires Visual Analog Scale for pain (0=No pain - 10 = Worst pain possible) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of analgesic and anxiolytic medications | Within 48 hours before and after the procedure | 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. |
| Change from baseline in physiological factors associated with pain and anxiety - Heart Rate | Baseline, periprocedural | Heart rate (beats per minute) |
| Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate | Baseline, periprocedural | Respiratory rate (breaths per minute) |
| Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure | Baseline, Periprocedural | Blood pressure (mmHg) |
| Incidence of adverse events of interest | Within 10 days of the procedure | Patient-reported nausea, dizziness and increased anxiety will be collected |
Countries
Canada
Contacts
CONTACTMichele Jadin
Outcome results
None listed