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

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

History of epilepsy

Claustrophobia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: With virtual reality technologiesExperimental treatment 1 intervention
Group B: Without virtual reality technologiesNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

total propofol consumption

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

Time frame
at day 1

Secondary outcomes

1

Time of awakening

To compare the time to awakening after the end of the procedure between patients who received CRVT immersion and control patients.

Time frame
at day 1
2

patient satisfaction

To compare patient satisfaction with CRVT immersion with that of control patients. Questionnaire: Visual Analog Scale Patient satisfaction assessed using a 0-100 Visual Analog Scale (VAS) Patient satisfaction will be assessed using a visual analog scale ranging from 0 to 100, where higher scores indicate greater satisfaction (better outcome). This scale will evaluate the patient's experience regarding: * Pain * Nausea * Anxiety * Overall satisfaction The questionnaire will be administered in the outpatient unit prior to discharge

Time frame
at day 1
3

post-endoscopy anxiety assessement

To compare pre- and post-endoscopy anxiety in CRVT-immersion patients with that in control patients. Outcome Measure Description: Anxiety will be evaluated using the State-Trait Anxiety Inventory - State subscale (STAI-YA), a validated self-report questionnaire composed of 20 items rated on a 4-point Likert scale. * Score range: 20 (low anxiety) to 80 (high anxiety) * Interpretation: Higher scores indicate greater anxiety (worse outcome) The questionnaire will be administered twice: * Timepoint 1 - Upon arrival in the endoscopy unit (baseline) * Timepoint 2 - Immediately after the endoscopic procedure (Day 1) The difference in STAI-YA scores before and after the procedure will be compared between patients in the CRVT group and those in the control group

Time frame
at baseline and at day 1
4

Duration of hospitalization

To compare the duration of outpatient hospitalisation between the end of the procedure and discharge of patients who had undergone CRVT immersion with that of control patients

Time frame
at day 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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