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临床试验/NL-OMON47028
NL-OMON47028已完成不适用

Feasibility and clinical relevance of Virtual Reality Exposure Therapy in sepsis survivors - Virtual Reality among sepsis survivors

Sint Franciscus Gasthuis0 个研究点目标入组 70 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Healthy volunteers
  • - 18-75 years
  • - no previous history of ICU admission
  • - no previous VR experience
  • - no pregnant woman will be included
  • - no history of mental illness
  • - signed informed consent;2. Survivors of sepsis staying at the ICU
  • Patients with prolonged mechanical ventilation (>24 hours) and understanding of the
  • Dutch language are eligible for study participation if they are fulfilling the following criteria:
  • - Sepsis or septic shock according to the recent guidelines
  • - Patients between 18-75 years of age.
  • - Patients must be awake during VR-application
  • - Maximal Glasgow coma score.
  • - No clinical suspicion for an untreatable delirium. Delirium is defined as a positive CAM-ICU >1, or if a screening tool is not used, pragmatically defined as 1) new administration of haloperidol >1mg/day or other antipsychotic drug; or 2) delirium reported by a physician or ICU nurse in the patient record, as confirmed by a designated research nurse on site.
  • - Signed informed consent;3. Survivors of sepsis admitted to the hospital ward after ICU discharge
  • Patients with prolonged mechanical ventilation (>24 hours) and understanding of the
  • Dutch language are eligible for study participation if they are fulfilling the following criteria:
  • - Sepsis or septic shock according to the recent guidelines
  • - Patients between 18-75 years of age.
  • - Patients must be awake during VR-application
  • - Maximal Glasgow coma score.
  • - No clinical suspicion for an untreatable delirium. Delirium is defined as a positive CAM-ICU >1, or if a screening tool is not used, pragmatically defined as 1) new administration of haloperidol >1mg/day or other antipsychotic drug; or 2) delirium reported by a physician or ICU nurse in the patient record, as confirmed by a designated research nurse on site.
  • - Signed informed consent

排除标准

  • 1. Healthy volunteers
  • - Volunteers with established schizophrenia.
  • - Volunteers known with epilepsy;2. Survivors of sepsis staying at the ICU / 3. Survivors of sepsis admitted to the hospital ward after ICU discharge
  • The key exclusion criterion was cognitive impairment, as determined by the Telephone Interview of Cognitive Status (score <=27). The TICS is a brief, standardized test of cognitive functioning that was developed for use in situations where in-person cognitive screening is impractical or inefficient, i.e. an ICU ward in which there is high turnover of critically ill patients. Moreover TICS can be used in participants with visual or motor impairments and is proven to be useful in older patients. Although the TICS is designed to be administered using the telephone, it also may be administered face-to-face. We therefore will use the TICS in the current study.
  • Furthermore the following patients will be excluded:
  • - Patients who are pregnant
  • - Patients with established schizophrenia.
  • - Patients admitted for status epilepticus
  • - Patients known with epilepsy
  • - Patients with documented epileptic seizures the year prior to ICU admission
  • - Patients admitted after stroke, cerebral vascular accident, known hemiplegia or traumatic brain injury
  • - Patients admitted after drowning or drug overdose
  • - No signed informed consent

研究者

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