About this trial
90% of colonoscopies are performed with general anesthesia (GA). GA carries risks and requires a prior anesthesia consultation, a dedicated team and technical platform on the day of the examination. These constraints increase the time it takes to organize examinations. This was particularly highlighted during the recent health crisis. The success of colonoscopy without GA varies depending on the patient's experience of the examination. Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA. A 2017 meta-analysis showed that the use of virtual reality (VR) reduced pain and anxiety during care for burn victims, in trauma and oncology. In upper digestive endoscopy, retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia. Thus, if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability, more examinations without GA could be considered. It could also have an economic impact.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Hearing problems or low vision
Psychiatric or cognitive disorders hindering communication
History of epilepsy
Claustrophobia which can lead to a rejection of the virtual reality mask
Trial design
Parallel
Treatments tested in this trial
Use of a VR mask
DeviceVirtual reality mask
Standard of care
Other interventionWithout any premedication or anesthesia
Treatment groups
Trial outcomes
Primary outcomes
Rate of cecal intubation
Success of a total colonoscopy defined by the rate of cecal intubation (visualization of the ileocecal valve and the appendicular orifice with the endoscope located near the appendicular orifice) or visualization of the ileocecal anastomosis in case of history of surgery removing the ileocaecal valve
Secondary outcomes
Maximum pain assessed by the patient by numerical scale
The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain
Maximum pain assessed by the patient by numerical scale
The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain
Maximum anxiety assessed by the patient by numerical scale
The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety
Maximum anxiety assessed by the patient by numerical scale
The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: