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Not yet recruiting NCT06414239

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

No phase Interventional Digestive System Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Use of a VR mask, Standard of care.
Who it may be relevant to
Registry conditions: Digestive System Disease. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle

Overview

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.

Interventions

  • Device Use of a VR mask
    Virtual reality mask
  • Other Standard of care
    Without any premedication or anesthesia

Primary outcome measures

  • Rate of cecal intubation [Time frame: At day 0]
Secondary outcome measures (12)
  • Maximum pain assessed by the patient by numerical scale [Time frame: At day 0]
  • Maximum pain assessed by the patient by numerical scale [Time frame: At 1 month]
  • Maximum anxiety assessed by the patient by numerical scale [Time frame: At day 0]
  • Maximum anxiety assessed by the patient by numerical scale [Time frame: At 1 month]
  • Patient's opinion to repeat the examination under the same conditions [Time frame: At day 0]
  • Patient's opinion to repeat the examination under the same conditions [Time frame: At 1 month]
  • Duration of the examination [Time frame: At day 0]
  • Total duration of the procedure [Time frame: At day 0]
  • Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum [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]

Eligibility criteria

Inclusion criteria

Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia

Exclusion criteria

  • 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
  • History of cybercynetosis during previous use of VR
  • Chronic abdominal pain with baseline Visual analogue scale (VAS) > 5
  • Emergency examination
  • Patient participating in another interventional research on digestive endoscopy
  • Patient not speaking French
  • Patient under guardianship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06414239 · APHP220675

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗