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

PTSD Clinical Trial

— PIRAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125406
• Other study ID #: 2019-16
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: BENJAMIN COIFFARD, MD
• Phone: +33 491964355
• Email: Benjamin.COIFFARD[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2024
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression, Anxiety
• PTSD
• Transplantation, Lung

Intervention

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.

Locations

Country	Name	City	State
France	Assistance Publique Des Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months post lung transplantation
Secondary	Hospital Anxiety and Depression scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) measure anxiety and depression in a general medical population of patients.	3 and 6 months post lung transplantation
Secondary	The Impact of Event Scale -Revised	The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.	3 and 6 months post lung transplantation
Secondary	Post-traumatic stress disorder Checklist Scale (PCLS)	The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.	3 and 6 months post lung transplantation