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

NCT05973201 | Recruiting

• 3 other identifiers: APHP220834PHRIP-21-00552023-A00163-42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Respiratory Disorder; Lung Infection

Keywords

Virtual reality; Pulmonary fibroscopy; Anxiety; Pain; Intensive care

Outcome Measures

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.

  Immediately after BF

Secondary Outcomes (13)

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

  Immediately after BF

• 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)

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

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

  Immediately after BF

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

  Immediately after BF

• The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF

  Immediately after BF

Study Arms (2)

interventional arm

EXPERIMENTAL

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

Device: Virtual reality headset

Conventional arm

NO INTERVENTION

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

Interventions

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).

interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (5)

CHI Aix en Provence

Aix-en-Provence, 13100, France

RECRUITING

CHU Dijon

Dijon, 21079, France

RECRUITING

Hôpital Le Kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

WITHDRAWN

Hôpital européen Georges Pompidou - AP-HP

Paris, 75015, France

RECRUITING

Hôpital Foch

Suresnes, 92150, France

NOT YET RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra GOMES, Nurse

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie ZINDJIRDJIAN

CONTACT

+33 1 44 84 17 64; aurelie.zindjirdjian@aphp.fr

Youcef SEKOUR

CONTACT

+33 1 56 09 58 23; youcef.sekour@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients in whom elective BF has been scheduled and who have given consent to the study will be randomised (1:1) to either the control group (BF after local anaesthesia (LA)) or the experimental group (BF after AL and VR immersion). Randomization will be done 30 minutes before BF, after an initial assessment of anxiety (pre-BF VAS) and will be stratified according to whether or not a psychotropic drug and/or a level II analgesic is taken the day before or on the day of BF. The randomization list will be programmed in advance by the study statistician using SAS software and will be generated and edited by another statistician independent of the study from the HEGP clinical research unit. The randomization list will be kept by the study sponsor (AP-HP). It will be available to users via web-based software (CleanWeb software (Telemedicine Technologies, http: //www.tentelemed.com/la-solution-cleanweb/)\].

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 2, 2023
• Study Start: October 19, 2023
• Primary Completion: October 19, 2025
• Study Completion: October 26, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR)

Locations

FR (5)