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NCT Number: NCT06414239

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

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

  • 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

Treatment and study plan

Use of a VR mask

Device

Virtual reality mask

Standard of care

Other

Without any premedication or anesthesia

Primary outcomes

  1. Rate of cecal intubation

    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

Secondary outcomes

  1. Maximum pain assessed by the patient by numerical scale

    Time frame: At day 0

    The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain

  2. Maximum pain assessed by the patient by numerical scale

    Time frame: At 1 month

    The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain

  3. Maximum anxiety assessed by the patient by numerical scale

    Time frame: At day 0

    The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety

  4. Maximum anxiety assessed by the patient by numerical scale

    Time frame: At 1 month

    The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety

  5. Patient's opinion to repeat the examination under the same conditions

    Time frame: At day 0

    It will be assesses by the Likert scale

  6. Patient's opinion to repeat the examination under the same conditions

    Time frame: At 1 month

    It will be assesses by the Likert scale

  7. Duration of the examination

    Time frame: At day 0

    Time between introduction and removal of the colonoscope

  8. Total duration of the procedure

    Time frame: At day 0

    time between entering and leaving the room

  9. Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum

    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.

  10. Proportion of procedures where the VR mask is removed at the patient's request

    Time frame: Up to 30 months

  11. Proportion of colonoscopies with detection of at least one adenoma

    Time frame: Up to 30 months

  12. Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group

    Time frame: Up to 30 months

  13. Operator satisfaction

    Time frame: Up to 30 months

    Assessed by the Analogue Visual Scale examination

  14. Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success

    Time frame: Up to 30 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, Pr

CONTACT

[email protected]

+33142499742

My-Linh TRAN-MINH, Dr

CONTACT

[email protected]

+33142499597

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: REVENDO

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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