Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies (EASY-HD)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Michele Jadin
- Telefonnummer: 4186568711
- E-post: michele.jadin@criucpq.ulaval.ca
Studiesteder
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Quebec
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Québec, Quebec, Canada, G1V 4G5
- IUCPQ
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Hovedetterforsker:
- Olivier F Bertrand, MD, PhD
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Ta kontakt med:
- Michele Jadin
- Telefonnummer: 418-656-8711
- E-post: michele.jadin@criucpq.ulaval.ca
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control
Standard of care analgesic and anxiolytic therapy
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|
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Eksperimentell: 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).
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Auditive distraction therapy
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Eksperimentell: 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).
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Virtual reality-lead audiovisual experience
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in patient-reported anxiety
Tidsramme: Baseline (preprocedural), periprocedural and at one-week follow-up
|
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
Tidsramme: Baseline, Periprocedural, and at one-week follow-up
|
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
Tidsramme: Baseline, periprocedural and at one-week follow-up
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Use of analgesic and anxiolytic medications
Tidsramme: Within 48 hours before and after the procedure
|
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. |
Within 48 hours before and after the procedure
|
|
Change from baseline in physiological factors associated with pain and anxiety - Heart Rate
Tidsramme: Baseline, periprocedural
|
Heart rate (beats per minute)
|
Baseline, periprocedural
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|
Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate
Tidsramme: Baseline, periprocedural
|
Respiratory rate (breaths per minute)
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Baseline, periprocedural
|
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Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure
Tidsramme: Baseline, Periprocedural
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Blood pressure (mmHg)
|
Baseline, Periprocedural
|
|
Incidence of adverse events of interest
Tidsramme: Within 10 days of the procedure
|
Patient-reported nausea, dizziness and increased anxiety will be collected
|
Within 10 days of the procedure
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of adverse cardiac events
Tidsramme: Within 10 days of the procedure
|
Within 10 days of the procedure
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EASY-HD
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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