Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here