Clinical trial NCT06999525: Use of Virtual Reality Technologies in Management of Anxiety and Discomfort During Endoscopy Procedure
Official title: Use of Virtual Reality Technologies in Management of Anxiety and Discomfort During Endoscopy Procedure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endoscopy
Keywords: Endoscopy
Virtual reality technologies
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a single-centre randomised controlled trial. The aim is to compare total propofol consumption between patients who have benefited from CRVT immersion and control patients.

All consecutive eligible patients will be informed of the study and invited to participate, by the prescribing physicians, in consultation or during hospitalisation as part of their care. The presentation of the research will also include a demonstration of the use of the CRVT in the digestive endoscopy department.

Patients who agree to take part will be included on the day of the procedure and randomised immediately afterwards by the doctor performing the endoscopy, in a 1:1 ratio, using a secure web server.

Patients randomised to the experimental arm will receive CRVT pre-operatively. Pre-operative anxiety (STAI) will be measured on two occasions: on arrival in the endoscopy department (at reception) and before the endoscopic procedure (in the endoscopy room).

Sedation will be provided by IV propofol only, by AIVOC. The depth of sedation will be monitored by measuring the bispectral index (BIS), with the aim of achieving a score of ≤ 75. Maintenance of sedation in the target zone will be achieved by adjusting the target concentration of AIVOC, with a BIS target of between 65 and 75. The time between the end of the procedure and actual awakening will be recorded in the endoscopy room.

Patient satisfaction (quantitative scale from 0 to 100) will be assessed in the outpatient department (during the pre-discharge visit). The time elapsed between the end of the procedure and discharge from the outpatient department will be recorded at the time of discharge.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of epilepsy
* Claustrophobia

Primary outcomes:
measure: total propofol consumption
timeFrame: at day 1
Secondary outcomes:
measure: Time of awakening
timeFrame: at day 1
measure: patient satisfaction
timeFrame: at day 1
measure: post-endoscopy anxiety assessement
timeFrame: at baseline and at day 1
measure: Duration of hospitalization
timeFrame: at day 1
Other outcomes:
Locations:
Study officials:
affiliation: CHU Ambroise Paré, APHP, France
name: Thomas BAZIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: