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

January 26, 2021 updated by: Centre Chirurgical Marie Lannelongue

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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Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

152

Phase

  • 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 Locations

  • France
      • Le Plessis Robinson, France, 92350
        • Recruiting
        • Centre chirurgical Marie Lannelongue
        • Contact:

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
EXPERIMENTAL: Virtual Reality group
Other: Virtual Reality
a bronchial fibroscopy with a virtual reality helmet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Centre Chirurgical Marie Lannelongue

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)

January 14, 2021

Primary Completion (ANTICIPATED)

January 14, 2024

Study Completion (ANTICIPATED)

February 14, 2024

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (ACTUAL)

February 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00658-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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