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

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.

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.

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)