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

NCT ID: NCT05973201

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2025-10-26

Brief Summary

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.

Detailed Description

Bronchial fibroscopy (BF) is an invasive examination mainly performed in vigilant patients under local anesthesia very regularly performed in patients hospitalized in critical care. Despite local anesthesia, and paradoxically also because of local anesthesia that makes the airflow in the upper airway imperceptible, BF is an anxiety-provoking and sometimes uncomfortable examination. Drug options are offered by physicians on a case-by-case basis and in response to patients' discomfort or anxiety. We believe that a preventive, non-drug strategy would improve comfort, reduce anxiety and improve patients' experience during BF. To reduce anxiety and improve patient comfort, there are non-drug alternatives such as hypnosis, music therapy or virtual reality. Hypnosis requires the availability of previously trained caregivers and a calm environment. Music therapy is difficult to apply in IS because of pre-existing noise pollution. We hypothesize that virtual reality would reduce patient anxiety during a bronchial fibroscopy in bed in critical care, improve the patient and caregiver experience and optimize its realization. Virtual reality (VR) is a technology that allows the patient to be projected, via a computer system, into an immersive virtual world. The patient's immersion in the virtual environment is accompanied by the feeling of "presence" which can be defined as the authentic feeling of existing in a world other than the one where the body is physically located.This specificity, coupled with the ability to isolate the patient's visual and auditory field, make this tool a promising solution to improve the well-being of patients during the care offer. VR is distributed by a set of devices to digitally simulate an environment mobilizing the different senses of its user: sight most often but possibly also touch, hearing or smell. VR, most often distributed via video and audio headset, is a complete immersive experience that can bring together hypnotic scenario and music therapy.

HEALTHY MIND® has designed a VR headset to relieve pain and anxiety in patients in healthcare facilities in a non-drug way. Indeed, this helmet has been developed to exercise analgesic and anxiolytic actions through specific virtual environments by combining different principles such as medical hypnosis, music therapy, light therapy and cardiac coherence. The proposed immersion themes combined with breathing exercises in the initial phase, generate better stress management.

Conditions

Respiratory Disorder; Lung Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

interventional arm

Fibroscopy performed under local anesthesia with immersion in a virtual reality scenario

Group Type: EXPERIMENTAL

Virtual reality headset

Intervention Type: 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).

Conventional arm

Fibroscopy performed under local anesthesia without immersion in a virtual reality scenario

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality headset

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 FB
• First BF during hospitalization
• Having signed a consent to participate in the study
• Affiliation to social security

Exclusion Criteria

• 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
• BF for a vital emergency
• Prior inclusion in the study
• Pregnant or breastfeeding women
• Presence of a tracheostomy or tracheostomy
• Participation in other intervention research
• Epilepsy
• Visual impairment (blindness) or severe hearing impairment (hearing loss, deafness) that does not allow the use of the helmet
• Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
• Autism spectrum disorders
• Patient sensitive to motion sickness
• Refractory migraine under treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra GOMES, Nurse

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

CHI Aix en Provence

Aix-en-Provence, , France

Site Status: RECRUITING

CHU Dijon

Dijon, , France

Site Status: RECRUITING

Hôpital Le Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Site Status: WITHDRAWN

Hôpital européen Georges Pompidou - AP-HP

Paris, , France

Site Status: RECRUITING

Hôpital Foch

Suresnes, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Aurélie ZINDJIRDJIAN

Role: CONTACT

aurelie.zindjirdjian@aphp.fr

+33 1 44 84 17 64

Youcef SEKOUR

Role: CONTACT

youcef.sekour@aphp.fr

+33 1 56 09 58 23

Facility Contacts

Youssef TRIGUI, MD

Role: primary

ytrigui@ch-aix.fr

+334 42 33 90 33

Youssef TRIGUI, MD

Role: backup

Marjolaine GEORGES, MD

Role: primary

marjolaine.georges@chu-dijon.fr

+333 80 29 37 72

Marjolaine GEORGES, MD

Role: backup

Alexandra GOMES, Nurse

Role: primary

alexandra.gomes@aphp.fr

+331 56 09 25 64

Anaïs RASTELLO, Nurse

Role: backup

Floriane Costani, Nurse

Role: primary

f.costani@hopital-foch.com

+33 1 46 25 29 07

Floriane Costani, Nurse

Role: backup

Other Identifiers

PHRIP-21-0055

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-A00163-42

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220834

Identifier Type: -

Identifier Source: org_study_id