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

NCT05125406 | Completed

• 1 other identifier: 2019-16
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplantation, Lung; Depression, Anxiety; PTSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospital Anxiety and Depression scale (HADS)

  Post-transplant

• The Impact of Event Scale -Revised

  Post-transplant

• Post-traumatic stress disorder Checklist Scale (PCLS)

  Post-transplant

Study Arms (2)

Exposure therapy using Virtual Reality (ETVR)

EXPERIMENTAL

Behavioral: Exposure therapy with Virtual Reality.

No exposure therapy with Virtual Reality.

NO INTERVENTION

Interventions

Exposure therapy with Virtual Reality. BEHAVIORAL

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.

Exposure therapy using Virtual Reality (ETVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: February 8, 2021
• Primary Completion: February 2, 2024
• Study Completion: June 17, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

FR (1)