Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Use of a VR mask

    Device

    Virtual reality mask

  • Standard of care

    Other intervention

    Without any premedication or anesthesia

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Interventional groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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