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

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Depression, Anxiety; Transplantation, Lung
• Intervention / Treatment: Behavioral: Exposure therapy with Virtual Reality.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Des Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure therapy using Virtual Reality (ETVR)	Behavioral: Exposure therapy with Virtual Reality.; 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.
No Intervention: No exposure therapy with Virtual Reality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-transplant

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): June 17, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Behavior; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Desensitization, Psychologic; Implosive Therapy
• Other Study ID Numbers: 2019-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No