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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47028
Enrollment
70
Registered
2017-02-22
Start date
2017-11-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychischische ervaring /onduidelijkheid na IC opname PTSD Virtual Reality

Interventions

Therapy with VR is based on exposure-based therapy (VR-EBT or VRET: virtual reality exposure therapy). VRET effectively circumvents the natural tendency to avoid traumatic memories by directly deliv
if this is not possible then the therapy operates exclusively within the unseen world of the patient*s imagination. VRET is extensively used in the psychology for treatment.

Sponsors

Sint Franciscus Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To evaluate the feasibility and clinical relevance of Virtual Reality Exposure Therapy among survivors of sepsis

Secondary

MeasureTime frame
1. To determine if adaptation (pre-exposure) is accompanied with a reduction of cybersickness during the VR-ICU application Treatment related information for healthy volunteers and patients - Age - Sex - BMI - Race - Heart rate - Saturation - Respiratory rate Treatment related information only in patients. - Biochemical data - Source of infection, No. (%) (Community acquired vs nosocomial) - Recent surgical history, No. (%) - Sputum cultures - Blood cultures - Wound cultures - ICU stay (days) - Hospital stay (days) - APACHE II / APACHE IV / SOFA score. - Days of mechanical ventilation (endotracheal vs tracheotomy) - Noninvasive ventilation - Renal replacement therapy - Use of vasopressors - Use of (analgo)-sedatives (remifentanil/ propofol etc) - Use of analgetics (morfine / paracetamol / sufentanyl / fentanyl) - Scoring of delirium - Use of Haldol - RASS score - VAS score - CAM ICU score - TICS score

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)