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Not yet recruiting NCT07681180

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

No phase Interventional Cardiovascular Disease Cardiovascular Care Pain and Anxiety During Cardiac Catheterization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auditive experience, Audiovisual immersive experience.
Who it may be relevant to
Registry conditions: Cardiovascular Disease, Cardiovascular Care, Pain and Anxiety During Cardiac Catheterization. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Auditive experience
    Auditive distraction therapy
  • Other Audiovisual immersive experience
    Virtual reality-lead audiovisual experience

Primary outcome measures

  • Change in patient-reported anxiety [Time frame: Baseline (preprocedural), periprocedural and at one-week follow-up]
  • Change in patient-reported anxiety [Time frame: Baseline, Periprocedural, and at one-week follow-up]
  • Change in patient-reported pain [Time frame: Baseline, periprocedural and at one-week follow-up]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • IUCPQ — Québec

Identifiers

NCT: NCT07681180 · EASY-HD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗