Use of a VR mask
DeviceVirtual reality mask
NCT Number: NCT06414239
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.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia
Exclusion criteria
Virtual reality mask
Without any premedication or anesthesia
Time frame: At day 0
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
The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain
Time frame: At 1 month
The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain
Time frame: At day 0
The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety
Time frame: At 1 month
The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety
Time frame: At day 0
It will be assesses by the Likert scale
Time frame: At 1 month
It will be assesses by the Likert scale
Time frame: At day 0
Time between introduction and removal of the colonoscope
Time frame: At day 0
time between entering and leaving the room
Time frame: At day 0
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: Up to 30 months
Time frame: Up to 30 months
Time frame: Up to 30 months
Time frame: Up to 30 months
Assessed by the Analogue Visual Scale examination
Time frame: Up to 30 months
Contact information is provided by the study sponsor or research team.
Jérôme Lambert, Pr
CONTACT
My-Linh TRAN-MINH, Dr
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle
Acronym: REVENDO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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