Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study
- Conditions
- Depression, AnxietyTransplantation, LungPTSD
- Interventions
- Behavioral: Exposure therapy with Virtual Reality.
- Registration Number
- NCT05125406
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Age above 18 years
- Registration on the lung transplant waiting list
- Signature of consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exposure therapy using Virtual Reality (ETVR) Exposure therapy with Virtual Reality. -
- Primary Outcome Measures
Name Time Method Spielberger state trait anxiety inventory for adults 3 months post lung transplantation 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
Name Time Method Post-traumatic stress disorder Checklist Scale (PCLS) 3 and 6 months post lung transplantation The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.
The Impact of Event Scale -Revised 3 and 6 months post lung transplantation The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.
Hospital Anxiety and Depression scale (HADS) 3 and 6 months post lung transplantation The Hospital Anxiety and Depression Scale (HADS) measure anxiety and depression in a general medical population of patients.
Trial Locations
- Locations (1)
Assistance Publique Des Hôpitaux de Marseille
🇫🇷Marseille, France