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Trial record 4 of 98 for:    Marie Lannelongue | France
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Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients. (REVDOU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04731792
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Study Description
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Brief 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.

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Condition or disease Intervention/treatment Phase
Anxiety Stress Pain Bronchial Fibroscopy Pulmonary Transplantation Other: Virtual Reality Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.
Actual Study Start Date : January 14, 2021
Estimated Primary Completion Date : January 14, 2024
Estimated Study Completion Date : February 14, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Virtual Reality group Other: Virtual Reality
a bronchial fibroscopy with a virtual reality helmet
No Intervention: control group


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified). [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain) [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04731792


Contacts
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Contact: Cécile DEGOULET 01 40 94 25 98 c.degoulet@ghpsj.fr

Locations
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France
Centre Chirurgical Marie Lannelongue Recruiting
Le Plessis Robinson, France, 92350
Contact: cecile Degoulet    01.40.94.25.98    c.degoulet@ghpsj.fr   
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
More Information
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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT04731792    
Other Study ID Numbers: 2020-A00658-31
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders