Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies (EASY-HD)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Disease; Cardiovascular Care; Pain and Anxiety During Cardiac Catheterization
• Intervention / Treatment: Other: Auditive experience; Other: Audiovisual immersive experience

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Jadin; Phone Number: 4186568711; Email: michele.jadin@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • IUCPQ
      • Principal Investigator: Olivier F Bertrand, MD, PhD
      • Contact: Michele Jadin; Phone Number: 418-656-8711; Email: michele.jadin@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care analgesic and anxiolytic therapy
Experimental: Auditive experience; 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; Auditive distraction therapy
Experimental: Immersion 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; Virtual reality-lead audiovisual experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse cardiac events	Within 10 days of the procedure

Collaborators and Investigators

• Sponsor: Olivier F. Bertrand

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Cardiovascular Diseases
• Other Study ID Numbers: EASY-HD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No