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NCT04731792 Clinical Trial

Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.

Pain Clinical Trial

— REVDOU  

Official title:
Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04731792
Other study ID # 2020-A00658-31
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 14, 2021
Est. completion date February 14, 2024

Study information
Verified date January 2021
Source Centre Chirurgical Marie Lannelongue
Contact Cécile DEGOULET
Phone 01 40 94 25 98
Email c.degoulet@ghpsj.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. These patients take many medications (immunosuppressants, antibiotics....) that may interact with analgesic or anxiolytic drugs. The objective is to propose to HML lung transplant patients a virtual reality solution containing visual and auditory 3D experiences to fight against anxiety and pain during repetitive and anxiogenic examinations such as bronchial fibroscopies. Translated with www.DeepL.com/Translator (free version)

Recruitment information / eligibility
Status Recruiting
Enrollment 152
Est. completion date February 14, 2024
Est. primary completion date January 14, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with a lung or cardio-pulmonary transplant - Adults (age > 18 years old) - Patient who give their informed consent for the protocol - Patient requiring a bronchial fibroscopy and having already had at least one - bronchial fibroscopy without virtual reality Exclusion Criteria: - children

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Virtual Reality
a bronchial fibroscopy with a virtual reality helmet

Locations
Country Name City State
France Centre Chirurgical Marie Lannelongue Le Plessis Robinson

Sponsors (1)
Lead Sponsor Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified). 1 day
Secondary Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain) 1 day
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