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

NCT07681180 | Not Yet Recruiting

• 1 other identifier: EASY-HD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Cardiovascular Care; Pain and Anxiety During Cardiac Catheterization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Use of analgesic and anxiolytic medications

  Within 48 hours before and after the procedure

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

  Baseline, periprocedural

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

  Baseline, periprocedural

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

  Baseline, Periprocedural

• Incidence of adverse events of interest

  Within 10 days of the procedure

Other Outcomes (1)

• Incidence of adverse cardiac events

  Within 10 days of the procedure

Study Arms (3)

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).

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).

Other: Audiovisual immersive experience

Interventions

Auditive experience OTHER

Auditive distraction therapy

Auditive experience

Audiovisual immersive experience OTHER

Virtual reality-lead audiovisual experience

Immersion experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 18 years or older
• Scheduled hemodynamic intervention (coronary angiography and/or angioplasty)
• Patient willing and able to understand the study
• Signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Olivier F. Bertrand: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michele Jadin

CONTACT

4186568711; michele.jadin@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: July 2, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

CA (1)