Relaxing Soundscapes + Virtual Reality for Catheterization Anxiety

(EASY-HD Trial)

MJ
Overseen ByMichele Jadin
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Olivier F. Bertrand
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults scheduled to have a coronary angiography or angioplasty (heart procedures). Participants should be able to answer questionnaires and not have conditions that would prevent them from using headphones or virtual reality devices.

Inclusion Criteria

Signed informed consent
I am 18 years old or older.
I am scheduled for a heart procedure like angiography or angioplasty.
See 1 more

Exclusion Criteria

Major hearing or visual impairment
Severe motion sickness or history of malaise with Virtual Reality (VR)
I have a history of epilepsy.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • Relaxing Soundscapes
  • Virtual Reality with Soundscapes

Trial Overview

The study compares two non-drug methods—listening to relaxing sounds or experiencing immersive virtual reality with soundscapes—against standard care, to see if they help reduce anxiety and stress during heart procedures.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Immersion experienceExperimental Treatment1 Intervention
Group II: Auditive experienceExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Olivier F. Bertrand

Lead Sponsor

Trials
3
Recruited
600+