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

Sponsor
Olivier F. Bertrand
Study ID
NCT07681180
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 2, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Control
    Standard of care analgesic and anxiolytic therapy
  • Experimental: Auditive experience
    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).
  • Experimental: Immersion experience
    A pre-defined virtual-reality led audiovisual experience will be used along standard of care pain and anxiety-relief medication (on patient's demand).

Primary Outcome Measure

Change in patient-reported anxiety [ Time Frame: Baseline (preprocedural), periprocedural and at one-week follow-up ]

Central Contacts

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