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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05125406
Acronym
PIRAT
Enrollment
62
Registered
2021-11-18
Start date
2021-02-08
Completion date
2024-06-17
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Anxiety, PTSD, Transplantation, Lung

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.

Interventions

BEHAVIORALExposure 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.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spielberger state trait anxiety inventory for adultsPost-transplantThe 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

MeasureTime frameDescription
Hospital Anxiety and Depression scale (HADS)Post-transplantThe Hospital Anxiety and Depression Scale (HADS) measure anxiety and depression in a general medical population of patients.
The Impact of Event Scale -RevisedPost-transplantThe IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.
Post-traumatic stress disorder Checklist Scale (PCLS)Post-transplantThe IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026