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NCT Number: NCT06999525

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

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.

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Key information

Conditions

Endoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. total propofol consumption

    Time frame: at day 1

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

Secondary outcomes

  1. Time of awakening

    Time frame: at day 1

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

  2. patient satisfaction

    Time frame: at day 1

    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

  3. post-endoscopy anxiety assessement

    Time frame: at baseline and at day 1

    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

  4. Duration of hospitalization

    Time frame: at day 1

    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

Study contacts

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

Paul Dessaint, MD

CONTACT

Thomas BAZIN, MD, PhD

CONTACT

[email protected]

33 + 01 40 87 57 95

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CARVENDO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 31, 2025
Registry last updated
May 31, 2025

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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