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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
240
Virtual reality mask
Without any premedication or anesthesia
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
Time frame: At day 0
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
Time frame: At day 0
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
Time frame: At 1 month
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
Time frame: At day 0
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
Time frame: At 1 month
Patient's opinion to repeat the examination under the same conditions
It will be assesses by the Likert scale
Time frame: At day 0
Patient's opinion to repeat the examination under the same conditions
It will be assesses by the Likert scale
Time frame: At 1 month
Duration of the examination
Time between introduction and removal of the colonoscope
Time frame: At day 0
Total duration of the procedure
time between entering and leaving the room
Time frame: At day 0
Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum
Between the introduction of the colonoscope and 30 minutes maximum. It can be the ileum in the event of a history of surgery removing the valve.
Time frame: At day 0
Proportion of procedures where the VR mask is removed at the patient's request
Time frame: Up to 30 months
Proportion of colonoscopies with detection of at least one adenoma
Time frame: Up to 30 months
Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group
Time frame: Up to 30 months
Operator satisfaction
Assessed by the Analogue Visual Scale examination
Time frame: Up to 30 months
Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success
Time frame: Up to 30 months
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