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

ConditionsCardiovascular DiseaseCardiovascular CarePain and Anxiety During Cardiac Catheterization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlivier F. Bertrand

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults, 18 years or older

Scheduled hemodynamic intervention (coronary angiography and/or angioplasty)

Patient willing and able to understand the study

Signed informed consent

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Auditive experience

    Other intervention

    Auditive distraction therapy

  • Audiovisual immersive experience

    Other intervention

    Virtual reality-lead audiovisual experience

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Auditive experienceExperimental treatment 1 intervention
Group C: Immersion experienceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline (preprocedural), periprocedural and at one-week follow-up
2

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

Time frame
Baseline, Periprocedural, and at one-week follow-up
3

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)

Time frame
Baseline, periprocedural and at one-week follow-up

Secondary outcomes

1

Use of analgesic and anxiolytic medications

Use vs no-use of analgesic (opioid/non-opioid) and/or anxiolytic medication. If analgesic and/or anxiolytic medication is used, its type, dose and frequency will be registered.

Time frame
Within 48 hours before and after the procedure
2

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

Heart rate (beats per minute)

Time frame
Baseline, periprocedural
3

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

Respiratory rate (breaths per minute)

Time frame
Baseline, periprocedural
4

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

Blood pressure (mmHg)

Time frame
Baseline, Periprocedural

Other outcomes

1

Incidence of adverse cardiac events

Time frame
Within 10 days of the procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olivier F. Bertrand

Lead sponsor

Laval University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: