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Набор скоро начнётся NCT07681180

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

Без фазы С лечением Cardiovascular Disease Cardiovascular Care Pain and Anxiety During Cardiac Catheterization

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Auditive experience, Audiovisual immersive experience.
Кому может быть актуально
Состояния в реестре: Cardiovascular Disease, Cardiovascular Care, Pain and Anxiety During Cardiac Catheterization. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies: EASY-HD Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Change in patient-reported anxiety [Срок оценки: Baseline (preprocedural), periprocedural and at one-week follow-up]
  • Change in patient-reported anxiety [Срок оценки: Baseline, Periprocedural, and at one-week follow-up]
  • Change in patient-reported pain [Срок оценки: Baseline, periprocedural and at one-week follow-up]
Вторичные конечные точки (5)
  • Use of analgesic and anxiolytic medications [Срок оценки: Within 48 hours before and after the procedure]
  • Change from baseline in physiological factors associated with pain and anxiety - Heart Rate [Срок оценки: Baseline, periprocedural]
  • Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate [Срок оценки: Baseline, periprocedural]
  • Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure [Срок оценки: Baseline, Periprocedural]
  • Incidence of adverse events of interest [Срок оценки: Within 10 days of the procedure]

Критерии участия

Критерии включения

  • Adults, 18 years or older
  • Scheduled hemodynamic intervention (coronary angiography and/or angioplasty)
  • Patient willing and able to understand the study
  • Signed informed consent

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Канада · 1 центр
  • IUCPQ — Québec

Идентификаторы

NCT: NCT07681180 · EASY-HD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗