Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05973201

Evaluation of Virtual Reality to Reduce Anxiety, Pain, and Duration of Non-emergency Bronchial Fibroscopy in Critical Care

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

120

Participants Needed

5

Research Sites

1 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

This research aims to evaluate whether virtual reality (VR) can reduce anxiety, pain, and the duration of bronchial fibroscopy (BF), a common invasive procedure performed in critical care patients under local anesthesia. BF can cause discomfort and anxiety despite local anesthesia, and current drug treatments are given only when needed. VR, combining hypnosis, music therapy, and other techniques, is being studied as a non-drug way to improve patient comfort during BF in critical care settings. The study compares two groups: one undergoing BF with immersion in a VR scenario using a HEALTHY MIND4 brand VR headset, and the other undergoing BF with local anesthesia alone. The VR headset offers immersive natural environments with hypnotic speech and music therapy, aiming to reduce patient stress. The procedure is performed while the patient is conscious and spontaneously breathing, with the VR intervention applied during the fibroscopy. Participants will be monitored for their anxiety and pain levels using visual analogue scales and other assessments immediately after BF, as well as at follow-up times including ICU discharge or up to 7 days later. Clinical measures such as pulse, respiratory rate, and blood pressure will be recorded before and during BF. Additional questionnaires will evaluate VR tolerance, drug use during BF, procedure quality, and patient satisfaction. The entire participation includes observation during BF and follow-up assessments for safety and experience.

CONDITIONS

Brief 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
  • Conscious with Glasgow score above 13
  • Spontaneous ventilation
  • Require bronchial fibroscopy
  • First bronchial fibroscopy during hospitalization
  • Signed consent to participate
  • Affiliated to social security
Not Eligible

You will not qualify if you...

  • Non-French-speaking patients
  • Protected minors or adults unable to consent
  • Major neurocognitive impairment
  • Refusal to participate
  • Patients on state medical aid
  • Under guardianship, curatorship, or judicial protection
  • Bronchial fibroscopy for vital emergency
  • Prior inclusion in the study
  • Pregnant or breastfeeding women
  • Presence of tracheostomy
  • Participation in other intervention research
  • Epilepsy
  • Visual or severe hearing impairment preventing VR use
  • Psychiatric conditions like delusions, hallucinations, or schizophrenia
  • Autism spectrum disorders
  • Motion sickness sensitivity
  • Refractory migraine under treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure day

Participants undergo bronchial fibroscopy under local anesthesia. Those in the experimental arm will experience immersion in a virtual reality scenario during the procedure to reduce anxiety and pain.

1 procedure visit (in-person)

Follow-up

Duration - Up to 7 days post-procedure

Participants complete questionnaires assessing tolerance to the virtual reality headset and satisfaction with the bronchial fibroscopy procedure up to 7 days after the procedure.

1 follow-up visit or remote assessment

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

Y

Youcef SEKOUR

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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