Feasibility and clinical relevance of Virtual Reality Exposure Therapy in sepsis survivors
- Conditions
- psychischische ervaring /onduidelijkheid na IC opnamePTSDVirtual Reality
- Registration Number
- NL-OMON47028
- Lead Sponsor
- Sint Franciscus Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the feasibility and clinical relevance of Virtual Reality Exposure<br /><br>Therapy among survivors of sepsis</p><br>
- Secondary Outcome Measures
Name Time Method