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

Primary Purpose

Anxiety, Stress, Pain

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Virtual Reality

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Chirurgical Marie LannelongueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality group

control group

Arm Description

Outcomes

Primary Outcome Measures

Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified).

Secondary Outcome Measures

Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain)

Full Information

NCT ID

NCT04731792

First Posted

January 21, 2021

Last Updated

January 26, 2021

Sponsor

Centre Chirurgical Marie Lannelongue

1. Study Identification

Unique Protocol Identification Number

NCT04731792

Brief Title

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

Acronym

REVDOU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 14, 2021 (Actual)

Primary Completion Date

January 14, 2024 (Anticipated)

Study Completion Date

February 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Chirurgical Marie Lannelongue

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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. Translated with www.DeepL.com/Translator (free version)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Stress, Pain, Bronchial Fibroscopy, Pulmonary Transplantation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Virtual Reality group

Arm Type

Experimental

Arm Title

control group

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Virtual Reality

Intervention Description

a bronchial fibroscopy with a virtual reality helmet

Primary Outcome Measure Information:

Title

Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified).

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain)

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cécile DEGOULET

Phone

01 40 94 25 98

c.degoulet@ghpsj.fr

Facility Information:

Facility Name

Centre Chirurgical Marie Lannelongue

City

Le Plessis Robinson

ZIP/Postal Code

92350

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

cecile Degoulet

Phone

01.40.94.25.98

c.degoulet@ghpsj.fr

12. IPD Sharing Statement

Learn more about this trial

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

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