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NCT Number: NCT07681180

Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Care Cardiovascular Diseases Neurologic Manifestations Pain Pain and Anxiety During Cardiac Catheterization Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location contact

Michele Jadin

CONTACT

[email protected]

418-656-8711

Olivier F Bertrand, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Auditive experience

Other

Auditive distraction therapy

Audiovisual immersive experience

Other

Virtual reality-lead audiovisual experience

Primary outcomes

  1. 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)

  2. 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

  3. 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)

Secondary outcomes

  1. Use of analgesic and anxiolytic medications

    Time frame: 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.

  2. Change from baseline in physiological factors associated with pain and anxiety - Heart Rate

    Time frame: Baseline, periprocedural

    Heart rate (beats per minute)

  3. Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate

    Time frame: Baseline, periprocedural

    Respiratory rate (breaths per minute)

  4. Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure

    Time frame: Baseline, Periprocedural

    Blood pressure (mmHg)

  5. Incidence of adverse events of interest

    Time frame: Within 10 days of the procedure

    Patient-reported nausea, dizziness and increased anxiety will be collected

Other outcomes

  1. Incidence of adverse cardiac events

    Time frame: Within 10 days of the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Jadin

CONTACT

[email protected]

4186568711

Sponsors and collaborators

Lead sponsor

Olivier F. Bertrand

Other

Registry information

Official study title

Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies: EASY-HD Pilot Study

Acronym: EASY-HD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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