Evaluation of Virtual Reality to Reduce Anxiety, Pain and Duration of Non-emergency Vigile Bronchial Fibroscopy (AVATAR)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be useful either for the diagnosis of the causal pathology of respiratory distress or for the diagnosis of lung infection, sometimes nosocomial. In patients in spontaneous and conscious ventilation, BF are performed vigil after local anesthesia according to the recommendations of the Société de Pneumologie de langue Française. The good tolerance of the examination and its good conduct may require the use of anxiolytics, sedatives or analgesics to limit the traumatic experience of a highly anxiety-provoking examination. Virtual reality (VR) combines a set of paramedical techniques (hypnosis, music therapy, sophrology) and is now a non-drug alternative to improve the tolerance of certain invasive gestures.VR has been shown to reduce pain and anxiety during first pathways placement or digestive endoscopies. To date, there is no evidence of the benefit of VR when performing semi-urgent BF in critical care areas.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (over 18 years of age)

Hospitalized in a critical care unit (intensive care and intensive care)

Conscious (Glasgow score >13)

Spontaneous ventilation

Disqualifiers

Non-French-speaking patient

Protected minors or adults who cannot consent to participate

People with major neurocognitive impairment

Patient refusing to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality headset

    Device

    A HEALTHY MIND® brand VR headset is dedicated to the study. The kit includes a noise-reducing audio headset, a face mask diffusing the visual part, a touchscreen tablet connected to the two VR headset systems, and a microphone connected to the tablet. The available software allows patients to choose between 5 natural environments in which a hypnotic speech is broadcast, available in several languages (French, English, Spanish, Russian, Arabic).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: interventional armExperimental treatment 1 intervention
Group B: Conventional armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF

The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.

Time frame
Immediately after BF

Secondary outcomes

1

The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale)

The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 1 to 4 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. The state scale has 10 reverse-scored items, the trait scale has 7. Scores of both scales ranges from 20 to 80.

Time frame
Immediately after BF
2

Patient's anxiety when leaving the intensive care unit (or on the 7th day at the latest, after BF) assessed by the visual analogue scale (VAS)

The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.

Time frame
When leaving the intensive care unit or on the 7th day at the latest, post BF
3

Maximum value of patient's pain experienced during BF assessed by the visual analogue scale (VAS) immediately after the FB

The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of pain" and the other to "maximum pain imaginable". The patient must then place the cursor where he locates his pain. VAS ranges from 0 to 100 mm.

Time frame
Immediately after BF
4

Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB

The ALGOPLUS scale was specifically developed to evaluate and manage acute pain in the elderly in all situations in which reliable self-assessment is not feasible. The scale is composed of 5 items (observational areas/domains). Each item checked "yes" is accorded 1 point and the sum of checked items gives a total score ranging from 1 to 5.

Time frame
Immediately after BF

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Ministry of Health, France

Collaborator