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Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study (PIRAT)

Primary Purpose

Transplantation, Lung, Depression, Anxiety, PTSD

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exposure therapy with Virtual Reality.
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Transplantation, Lung

Eligibility Criteria

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

Inclusion Criteria:

  • Age above 18 years
  • Registration on the lung transplant waiting list
  • Signature of consent

Exclusion Criteria:

  • Minor patient, pregnant or breastfeeding woman, or not affiliated to the social security scheme
  • Patient under guardianship or curatorship
  • Patient with a history of mental illness
  • Patient not mastering the French language
  • Patient deprived of liberty
  • Patient carrying a transplanted organ (liver, kidney, heart ...)
  • Lung re-transplantation

Sites / Locations

  • Assistance Publique Des Hôpitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exposure therapy using Virtual Reality (ETVR)

No exposure therapy with Virtual Reality.

Arm Description

Outcomes

Primary Outcome Measures

Spielberger state trait anxiety inventory for adults
The State-Trait Anxiety Inventory (STAI) has been used extensively in research and clinical practice. It comprises separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment." The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how people generally feel.

Secondary Outcome Measures

Hospital Anxiety and Depression scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) measure anxiety and depression in a general medical population of patients.
The Impact of Event Scale -Revised
The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.
Post-traumatic stress disorder Checklist Scale (PCLS)
The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.

Full Information

First Posted
November 8, 2021
Last Updated
November 8, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05125406
Brief Title
Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study
Acronym
PIRAT
Official Title
Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
February 8, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
ICU patients frequently face complicated recovery processes, including long-term anxiety disorders. Lung transplantation (LTx) offers people with terminal respiratory conditions both the hope of prolonged survival and a better quality of life related to health. Among the disorders usually encountered in the postoperative period of LTx are anxio-depressive disorders. These anxiety disorders affect the quality of life related to health and compromise the follow-up of the patient by phenomenon of psychological disinvestment. Other psychological disorders are also anchored in the patient's experience of this post-surgical ICU period (ie, depressive episodes and/or, at a distance, post-traumatic stress disorder (PTSD). Various models of management of anxio-depressive disorders and PTSD are proposed in the literature. To our knowledge, while many of them have shown their efficiency in the curative management of disorders, few have demonstrated their effectiveness in preventing them. Exposure therapies using virtual reality (ETVR) have in the past demonstrated their effectiveness in many areas of psychiatry. In our study, experimental arm patients will be offered ETRV support with a virtual reality headset. A scenario with progressively increasing stress levels linked to the ICU environment and different situational contexts (alarms, etc.) will be presented to patients. This habituation to the potentially anxiety context of ICU will reduce the occurrence of psycho-cognitive disorders by progressive extinction phenomenon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplantation, Lung, Depression, Anxiety, PTSD

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure therapy using Virtual Reality (ETVR)
Arm Type
Experimental
Arm Title
No exposure therapy with Virtual Reality.
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exposure therapy with Virtual Reality.
Intervention Description
Experimental arm patients will be offered Exposure therapy with Virtual Reality (ETRV) support with a virtual reality headset. A scenario with progressively increasing stress levels linked to the ICU environment and different situational contexts (alarms, etc.) will be presented to patients. This habituation to the potentially anxiety context of ICU will reduce the occurrence of psycho-cognitive disorders by progressive extinction phenomenon.
Primary Outcome Measure Information:
Title
Spielberger state trait anxiety inventory for adults
Description
The State-Trait Anxiety Inventory (STAI) has been used extensively in research and clinical practice. It comprises separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment." The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how people generally feel.
Time Frame
3 months post lung transplantation
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression scale (HADS)
Description
The Hospital Anxiety and Depression Scale (HADS) measure anxiety and depression in a general medical population of patients.
Time Frame
3 and 6 months post lung transplantation
Title
The Impact of Event Scale -Revised
Description
The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.
Time Frame
3 and 6 months post lung transplantation
Title
Post-traumatic stress disorder Checklist Scale (PCLS)
Description
The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.
Time Frame
3 and 6 months post lung transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age above 18 years Registration on the lung transplant waiting list Signature of consent Exclusion Criteria: Minor patient, pregnant or breastfeeding woman, or not affiliated to the social security scheme Patient under guardianship or curatorship Patient with a history of mental illness Patient not mastering the French language Patient deprived of liberty Patient carrying a transplanted organ (liver, kidney, heart ...) Lung re-transplantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BENJAMIN COIFFARD, MD
Phone
+33 491964355
Email
Benjamin.COIFFARD@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
EMILIE GARRIDO-PRADALIE, Study Director
Facility Information:
Facility Name
Assistance Publique Des Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BENJAMIN COIFFARD, MD
Phone
+33 491964355
Email
Benjamin.coiffard@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study

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