To evaluate the feasibility and clinical application of Virtual Reality (headmounted display and software) among sepsis survivors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychischische ervaring /onduidelijkheid na IC opname
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the feasibility and clinical relevance of Virtual Reality Exposure
Therapy among survivors of sepsis
Secondary outcome
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
Background summary
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 delivering multisensory and contextual
cues that help the patient retrieve, confront, and process these experiences.
VR also provides the therapist with an objective and consistent format for
documenting the sensory stimuli to which a patient is exposed and the resulting
reactions; if this is not possible then the therapy operates exclusively
within the unseen world of the patient*s imagination
VR typically refers to computer technologies that use software to generate
realistic images, sounds and other sensations that replicate a real environment
(or create an imaginary setting), and simulate a user's physical presence in
this environment, by enabling the user to interact with this space and any
objects depicted therein using specialized display projectors. Most 2016-era
virtual realities are displayed with a virtual reality headset (also called
head-mounted display or HMD). Virtual realities artificially create sensory
experiences, which can include sight, touch, and hearing.
Medical therapies might benefit from becoming integrated in future exciting
technical innovations, such as VR. VR is still far from mainstream in the
medical world, but its tri-dimensional environment has potential to influence
multiple areas that can immediately impact both patients and physicians.
VR-training has already been shown to improve operating room performance in
surgeons6 and in ophthalmologists , and helps training of general practitioners
in prescribing antibiotics.
In addition, several recent studies showed beneficial effects of VRET for
patients with several mental health disorders such as panic disorders, social
anxiety, fear of public speaking, for the management of psychological stress,
and in patients with post-traumatic stress disorder. From a psychological point
of view VRET may help to modify behaviors, thoughts, and emotions through
virtual experiences designed for and adapted to the person*s needs, in order to
facilitate and enhance a process of change. Besides improving cognitive and
psychological performance, recent research demonstrated that VRET may also have
a beneficial effect on physical function. For instance VR has a positive impact
in alleviating pain after burn injury, improves motor function in older
patients, and improves balance and gait after stroke. Moreover, a recent trial
demonstrated that VR is a non-invasive, non-pharmacological, and engaging
treatment with no identified side-effects after critical illness.
In conclusion, VR is a highly potential technique which concurrently may have
beneficial value in different aspects of treating mental disorders and might
improve rehabilitation.
Critically ill patients admitted to the ICU often experience long term ICU
related physical and psychological complications, such as post-traumatic stress
disorders, depression, memory and attention deficit and pulmonary and
neuromusculair impairments. These impairments are part of the *post-ICU
syndrome* (PICS) which is associated with a decreased quality of life and a
significant socioeconomic burden.
All of these problems are prominently present in survivors of sepsis who are
mechanically ventilated >48 hours. Sepsis is de*ned as a powerful in*ammatory
response to severe infection. The annual total cost of sepsis syndromes in the
USA is $16.7 billion nationally. As the incidence is projected to increase by
1.5% per year, sepsis possess a major public health concern. The risk of dying
from sepsis has decreased in recent decades, owing to earlier detection and
more effective treatment. Sepsis patients demonstrate a sharp decline of
quality of life during ICU stay, which slightly improves at the ward but may
persist until 6 months after discharge. Because more patients survive sepsis
and are increasingly discharged from the hospital, it is to expect that more
patients have sequelae of the post-ICU syndrome and have declined of quality of
life. Several interventions to ameliorate post-ICU syndrome have been
implemented in the ICU, and in the hospital ward.
The effect of timing on different aspects of the post-ICU syndrome are however
still undetermined
Until now there is hardly any treatment to improve psychological recovery
after discharge from the ICU. VRET can provide patients with detailed/visual
information about their ICU admission and illness, we hypothesized that a VRET
in sepsis survivors is able to reduce post-ICU syndrome related impairments
irrespective of implementation at the ICU or at the ward.
The primary aim of the present pilot study is to determine whether VRET among
sepsis survivors on is feasible and could influence sequelea of the post-ICU
syndrome. A part of this VRET is pre-exposure, we will incorporate this as part
of the study
Study objective
To evaluate the feasibility and clinical application of Virtual Reality
(headmounted display and software) among sepsis survivors.
Study design
A multi center, randomized, placebo-controlled pilot study
Intervention
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 delivering multisensory and contextual
cues that help the patient retrieve, confront, and process these experiences.
VR also provides the therapist with an objective and consistent format for
documenting the sensory stimuli to which a patient is exposed and the resulting
reactions; 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.
Study burden and risks
No additional burden for the patient is expected. The VR technique is non*
invasive and the patient does not have to undergo extra invasive interventions.
No risks of VRET are currently known. Moreover several future studies showed
that VRET can be easily applied in elderly patients and does no harm nor had
side-effects.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL57641.101.16 |
OMON | NL-OMON27123 |