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

November 29, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France, 13100
        • Recruiting
        • CHI Aix en Provence
        • Contact:
        • Contact:
          • Youssef TRIGUI, MD
      • Dijon, France, 21079
        • Recruiting
        • CHU Dijon
        • Contact:
        • Contact:
          • Marjolaine GEORGES, MD
      • Le Kremlin-Bicêtre, France, 94270
        • Withdrawn
        • Hôpital Le Kremlin Bicêtre
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou - AP-HP
        • Contact:
          • Anaïs RASTELLO, Nurse
        • Contact:
      • Suresnes, France, 92150
        • Not yet recruiting
        • Hopital Foch
        • Contact:
        • Contact:
          • Floriane Costani, Nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: interventional arm
Fibroscopy performed under local anesthesia with immersion in a virtual reality scenario
Device: 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).
No Intervention: Conventional arm
Fibroscopy performed under local anesthesia without immersion in a virtual reality scenario

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF
Time Frame: Immediately after 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale)
Time Frame: Immediately after BF
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.
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)
Time Frame: When leaving the intensive care unit or on the 7th day at the latest, post 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.
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
Time Frame: Immediately after 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 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.
Immediately after BF
Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB
Time Frame: Immediately after BF
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.
Immediately after BF
The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF
Time Frame: Immediately after BF
The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF
Immediately after BF
The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF
Time Frame: Immediately after BF
The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF
Immediately after BF
The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF
Time Frame: Immediately after BF
The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF
Immediately after BF
The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy
Time Frame: Immediately after BF
The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy
Immediately after BF
Tolerance to the VR assessed by a questionnaire measuring the side effects of the VR
Time Frame: 1 day post BF
The questionnaire items lists the side effects of the VR (8 items with 3 answer categories: yes, no and do not know).
1 day post BF
Patient anxiety experienced before BF evaluated by the nursing staff assessed by Hamilton scale
Time Frame: Before BF
The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.The scale consists of 14 items designed to assess the severity of a patient's anxiety.
Before BF
The total dose of sedative and anxiolytic drugs administered during BF
Time Frame: Immediately after BF
The total dose of midazolam, alprazolam, hydroxyzine, diprivan, stage II or III analgesics administered during BF
Immediately after BF
The quality of FB (specific questionnaire completed by the physician describing the quality of exploration, the possibility of taking samples and the satisfaction VAS).
Time Frame: Immediately after BF
A specific questionnaire completed by the physician in charge of the BF will be used describing the quality of the exploration and the possibility of taking samples
Immediately after BF
Remote patient satisfaction with FB measured using the e-SATIS ?questionnaire (Haute Autorité de Santé "prise en charge" section), and the answer to the single question: "Would you have a bronchial fibroscopy again in the future)
Time Frame: 7 days post BF
E-SATIS is an experience and satisfaction questionnaire, in which all patients are invited to participate, following treatment in a health establishment, hospital or clinic. The questionnaire is validated by the French Haute autorité de santé. The "patient care" section of the questionnaire was used to assess remote patient's satisfaction on the BF procedure. For each responding patient, a score ranging from 1 [bad experience] to 5 [excellent experience] (transformed into a value from 0 to 100) is given to each of his answers.
7 days post BF

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandra GOMES, Nurse, Assistance Publique - Hopitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP220834
  • 2023-A00163-42 (Other Identifier: IDRCB)
  • PHRIP-21-0055 (Other Grant/Funding Number: French ministry of health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

One year after the last publication

IPD Sharing 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)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Infection

Clinical Trials on Virtual reality headset

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings