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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Michele Jadin
- Número de telefone: 4186568711
- E-mail: michele.jadin@criucpq.ulaval.ca
Locais de estudo
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Quebec
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Québec, Quebec, Canadá, G1V 4G5
- IUCPQ
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Investigador principal:
- Olivier F Bertrand, MD, PhD
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Contato:
- Michele Jadin
- Número de telefone: 418-656-8711
- E-mail: michele.jadin@criucpq.ulaval.ca
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control
Standard of care analgesic and anxiolytic therapy
|
|
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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).
|
Auditive distraction therapy
|
|
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).
|
Virtual reality-lead audiovisual experience
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in patient-reported anxiety
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Use of analgesic and anxiolytic medications
Prazo: 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
Prazo: Baseline, periprocedural
|
Heart rate (beats per minute)
|
Baseline, periprocedural
|
|
Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate
Prazo: Baseline, periprocedural
|
Respiratory rate (breaths per minute)
|
Baseline, periprocedural
|
|
Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure
Prazo: Baseline, Periprocedural
|
Blood pressure (mmHg)
|
Baseline, Periprocedural
|
|
Incidence of adverse events of interest
Prazo: Within 10 days of the procedure
|
Patient-reported nausea, dizziness and increased anxiety will be collected
|
Within 10 days of the procedure
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
Incidence of adverse cardiac events
Prazo: Within 10 days of the procedure
|
Within 10 days of the procedure
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EASY-HD
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