Меню
Идёт набор NCT05876117

Premedication for Claustrophobic Patients for MRI Scan

— Наблюдательное Claustrophobia

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Claustrophobia. Базовые параметры: 20 лет — 99 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Clonidine and Lorazepam Premedication for Claustrophobic Patients During MRI Scan

Обзор

Claustrophobia is an irrational fear of restriction and suffocation. It is a specific phobia, according to DSM 5. Claustrophobic patients may fear that restriction of their limbs will hinder their ability to move quickly towards safety. MRI may trigger claustrophobia, because this diagnostic procedure involves a patient laying in a narrow tube. Premedication before MRI scan may occasionally reduce claustrophobia. Prospective observational crossover study of claustrophobic patients who are undergoing MRI scan. At alternate MRI scan sessions, each patient receives rotational premedication using Lorazepam 1mg; or Clonidine tablet 0.2mg; or combined Clonidine 0.2mg + Lorazepam 1mg. Patient will use Claustrophobia Questionnaire, a validated tool, to collect data on the days before and after each MRI scan. CLQ is a patient-administered tool used to assess claustrophobia. In addition, patient will use General Anxiety Disorder Questionnaire, a validated tool, to collect data on the days before and after each MRI scan. GAD-7 is a patient-administered tool that is used to assess anxiety.

Подробное описание

Claustrophobia is an irrational fear of constraint, restriction, immobility, smothering and suffocation. Claustrophobia is a specific phobia, according to the Diagnostic and Statistical Manual 5 (DSM 5). The disorder affects 5% of the general population. Claustrophobic patients may fear that the restriction of their limbs will hinder their ability to move quickly towards perceived safety. Magnetic resonance imaging (MRI) may trigger claustrophobia, because this diagnostic procedure involves a patient staying immobile in a narrow and noisy tube. Anxiolytic premedication before MRI scan, using Lorazepam, may occasionally help to reduce claustrophobia.

This is a prospective observational crossover study of claustrophobic adult patients who are undergoing MRI scan as part of chronic pain management. At alternate MRI scan sessions, each patient receives rotational premedication using Lorazepam 1mg; or Clonidine tablet 0.2mg; or combined Clonidine 0.2mg + Lorazepam 1mg.

The patient will use the Claustrophobia Questionnaire (CLQ), a special validated tool, to collect data on the days before and after each MRI scan. The CLQ is a patient-administered tool that is used to record the severity and presence of claustrophobia symptoms, on a measurement range of 0 to 104. A change in the CLQ scores by 12-points is considered significant. In addition, the patient will use the General Anxiety Disorder Questionnaire (GAD-7), a special validated tool, to collect data on the days before and after each MRI scan. The GAD-7 is a patient-administered tool that is used to record the severity and presence of anxiety symptoms, on a measurement range of 0 to 21. A change in the GAD-7 scores by 3-points is considered significant.

Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 is considered significant.

Первичные конечные точки

  • Rate of completion of MRI scan [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • diagnosed with claustrophobia
  • previous incomplete MRI because of claustrophobia
  • adult patients
  • good treatment compliance
  • reliable Claustrophobia Questionnaire (CLQ) diary
  • reliable General Anxiety Disorder Questionnaire (GAD) diary
  • informed consent for diary review
  • consent for clinical record quality assurance review

Критерии исключения

  • poor treatment compliance
  • cognitive disorder
  • inability to provide consent
  • major neuropsychiatric disorder
  • unreliable diary
  • cannabis use
  • excessive alcohol intake
  • previous adverse/allergic reactions to clonidine
  • previous adverse/allergic reactions to lorazepam

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-кроссовер

Центры проведения

Канада · 1 центр
  • Salem Anaesthesia Pain Clinic — Surrey

Идентификаторы

NCT: NCT05876117 · SalemAnes2022 MRI Premedicate

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗