Cardiovascular DiseaseEASY-HDNCT07681180
Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies
A study testing Auditive experience and Audiovisual immersive experience in people with Cardiovascular Disease and Cardiovascular Care, run by Olivier F. Bertrand at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Cardiovascular Care, Pain and Anxiety During Cardiac Catheterization
- What is being tested?
- Auditive experience and Audiovisual immersive experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, 18 years or older
- Scheduled hemodynamic intervention (coronary angiography and/or angioplasty)
- Patient willing and able to understand the study
- Signed informed consent
Who cannot join
- 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
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- Claustrophobia
- Facial injuries
- In clinical isolation (infection control)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
IUCPQ
Québec, Quebec, G1V 4G5
Michele Jadin, 418-656-8711, michele.jadin@criucpq.ulaval.ca
Olivier F Bertrand, MD, PhD
About this study
Official title: Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies: EASY-HD Pilot Study
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.
Read more
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Cardiovascular Care, Pain and Anxiety During Cardiac Catheterization
- Being tested
- Auditive experience, Audiovisual immersive experience
- Medical subject headings
- Cardiovascular Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditive experienceOther
Auditive distraction therapy
Audiovisual immersive experienceOther
Virtual reality-lead audiovisual experience
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Auditive experience |
| 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). Receives: Other: Audiovisual immersive experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: Baseline, periprocedural and at one-week follow-up
Secondary outcomes (5)
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.
Measured: 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)
Measured: Baseline, periprocedural
Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate
Respiratory rate (breaths per minute)
Measured: Baseline, periprocedural
Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure
Blood pressure (mmHg)
Measured: Baseline, Periprocedural
Incidence of adverse events of interest
Patient-reported nausea, dizziness and increased anxiety will be collected
Measured: Within 10 days of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivier F. Bertrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olivier F. Bertrand, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681180
- Sponsor's protocol ID
- EASY-HD
- Acronym
- EASY-HD
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies: EASY-HD Pilot Study
- ClinicalTrials.gov ID
- NCT07681180
- Acronym / sponsor ID
- EASY-HD / EASY-HD
- Conditions
- Cardiovascular Disease, Cardiovascular Care, Pain and Anxiety During Cardiac Catheterization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Olivier F. BertrandUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care analgesic and anxiolytic therapy |
| Auditive experience | Experimental | Other: Auditive experienceA 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 | Other: Audiovisual immersive experienceA pre-defined virtual-reality led audiovisual experience will be used along standard of care pain and anxiety-relief medication (on patient's demand). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults, 18 years or older
- Scheduled hemodynamic intervention (coronary angiography and/or angioplasty)
- Patient willing and able to understand the study
- Signed informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditive experienceAuditive distraction therapy | Other | Auditive experience |
| Audiovisual immersive experienceVirtual reality-lead audiovisual experience | Other | Immersion experience |
Primary outcome
Change in patient-reported anxiety
Time frame: 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 anxiety
Time frame: Baseline, Periprocedural, and at one-week follow-up
Change from baseline in patient reported anxiety evaluated by anxiety questionnaires State-Trait Anxiety Invetory for Adults - 6 item short form
Change in patient-reported pain
Time frame: 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)
5 secondary outcomes
Use of analgesic and anxiolytic medications
Time frame: Within 48 hours before and after the procedure
Change from baseline in physiological factors associated with pain and anxiety - Heart Rate
Time frame: Baseline, periprocedural
Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate
Time frame: Baseline, periprocedural
Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure
Time frame: Baseline, Periprocedural
Incidence of adverse events of interest
Time frame: Within 10 days of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditive experience and Audiovisual immersive experience in people with Cardiovascular Disease and Cardiovascular Care, run by Olivier F. Bertrand at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Jadin (4186568711, michele.jadin@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported anxiety (time frame: Baseline (preprocedural), periprocedural and at one-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.