Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05973201 En recrutement IDF

Titre

Evaluation De La Réalité Virtuelle Pour Réduire L'anxiété, La Douleur Et De La Durée D'une Fibroscopie Bronchique Vigile Non Urgente En Soins Critiques

Type

Interventional

Pathologie

Troubles respiratoires
Maladies de l'appareil respiratoire

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

octobre 2023

Date de fin

octobre 2025

Dernière mise à jour

13 septembre 2025

Résumé

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.

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH	RASTELLO Anaïs	En recrutement IDF	27/12/2025 07:45:34	Contacter
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	27/12/2025 07:45:35	Contacter
	AP-HP - Hôpital Bicêtre
	AP-HP - Hôpital Europeen Georges Pompidou
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Foch - 92150 - Suresnes - France	Floriane Costani, Nurse	Recrutement non commencé	27/12/2025 07:45:34	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHI Aix en Provence - 13100 - Aix-en-Provence - France	Youssef TRIGUI, MD	En recrutement		Contact (sur clinicalTrials)
CHU Dijon - 21079 - Dijon - France	Marjolaine GEORGES, MD	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT05973201 - Evaluation De La Réalité Virtuelle Pour Réduire L'anxiété, La Douleur Et De La Durée D'une Fibroscopie Bronchique Vigile Non Urgente En Soins Critiques

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