Use of Virtual Reality Technologies in Management of Anxiety and Discomfort During Endoscopy Procedure

NCT06999525 | Not Yet Recruiting

• 2 other identifiers: APHP2313042025-A00550-49
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Digestive endoscopies are performed either for diagnostic purposes (e.g. suspicion of cancer or monitoring of chronic diseases) or for therapeutic purposes (treatment of digestive haemorrhage, removal of polyps, etc.). Some endoscopies are performed under local anaesthetic, which can cause considerable anxiety in anticipation of the procedure and considerable discomfort during the procedure. Other endoscopies are performed under general anaesthetic for more extensive procedures on outpatients or inpatients. Anxiety prior to anaesthesia is likely to increase the perception of pain, increase the need for anaesthetic products and thus increase the time to complete awakening. Complementary techniques such as hypnotherapy can be used before the operation, with proven effectiveness. But these techniques require dedicated and specifically trained staff, as well as additional time. Virtual reality technologies, and in particular virtual reality headsets, allow instant immersion in a relaxing world. Therapeutic virtual reality headsets (TRVH) have been shown to be effective in reducing pre-operative anxiety and pain perception. Our hypothesis is that the use of a CRVT could reduce the consumption of anaesthetic products, reduce anxiety, improve overall satisfaction and reduce the length of outpatient hospitalisation during digestive endoscopy procedures.

Conditions

Endoscopy

Keywords

Endoscopy; Virtual reality technologies

Outcome Measures

Primary Outcomes (1)

• total propofol consumption

  To compare total propofol consumption between patients who received CRVT immersion and control patients.

  at day 1

Secondary Outcomes (4)

• Time of awakening

  at day 1

• patient satisfaction

  at day 1

• post-endoscopy anxiety assessement

  at baseline and at day 1

• Duration of hospitalization

  at day 1

Study Arms (2)

With virtual reality technologies

EXPERIMENTAL

Patients with virtual reality technologies during endoscopy procedure

Device: Therapeutic virtual reality headset (CRVT)

Without virtual reality technologies

NO INTERVENTION

Routine procedure of endoscopy

Interventions

Therapeutic virtual reality headset (CRVT) DEVICE

Contribution of the use of a Therapeutic Virtual Reality Headset in the management of anxiety and discomfort in digestive endoscopy

With virtual reality technologies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years (adult patients)
• Affiliated with a French social security system
• No legal protection measures (e.g., guardianship, curatorship)
• Scheduled for outpatient digestive endoscopy (upper or lower) under general anesthesia, level 1 (excluding biliary or interventional procedures)
• Medical indication for the endoscopic procedure established by a clinician

You may not qualify if:

• History of epilepsy
• Claustrophobia

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Thomas BAZIN, MD, PhD

  CHU Ambroise Paré, APHP, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas BAZIN, MD, PhD

CONTACT

33 + 01 40 87 57 95; thomas.bazin@aphp.fr

Paul Dessaint, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 31, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05