Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05973201

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-04

120

Participants Needed

5

Research Sites

105 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

M

Ministry of Health, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (over 18 years of age)
  • Hospitalized in a critical care unit (intensive care and intensive care)
  • Conscious (Glasgow score >13)
  • Spontaneous ventilation
  • Requiring the realization of a bronchial fibroscopy
  • First bronchial fibroscopy during hospitalization
  • Having signed a consent to participate in the study
  • Affiliation to social security
Not Eligible

You will not qualify if you...

  • 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
  • Patient on State medical aid
  • Patient under guardianship or curatorship or under judicial protection
  • Bronchial fibroscopy for a vital emergency
  • Prior inclusion in the study
  • Pregnant or breastfeeding women
  • Presence of a tracheostomy
  • Participation in other intervention research
  • Epilepsy
  • Visual impairment (blindness) or severe hearing impairment preventing helmet use
  • Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia
  • Autism spectrum disorders
  • Patient sensitive to motion sickness
  • Refractory migraine under treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

CHI Aix en Provence

Aix-en-Provence, France, 13100

Actively Recruiting

2

CHU Dijon

Dijon, France, 21079

Actively Recruiting

3

Hôpital Le Kremlin Bicêtre

Le Kremlin-Bicêtre, France, 94270

Withdrawn

4

Hôpital européen Georges Pompidou - AP-HP

Paris, France, 75015

Actively Recruiting

5

Hôpital Foch

Suresnes, France, 92150

Not Yet Recruiting

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Research Team

A

Aurélie ZINDJIRDJIAN

CONTACT

Y

Youcef SEKOUR

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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