Clinical trial NCT05125406: Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study
Official title: Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transplantation, Lung
Depression, Anxiety
PTSD
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Spielberger state trait anxiety inventory for adults
timeFrame: 3 months post lung transplantation
Secondary outcomes:
measure: Hospital Anxiety and Depression scale (HADS)
timeFrame: 3 and 6 months post lung transplantation
measure: The Impact of Event Scale -Revised
timeFrame: 3 and 6 months post lung transplantation
measure: Post-traumatic stress disorder Checklist Scale (PCLS)
timeFrame: 3 and 6 months post lung transplantation
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Des Hôpitaux de Marseille
Study officials:
References: