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NCT05125406: PIRAT
Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study
NA trial testing Exposure therapy with Virtual Reality. in Transplantation, Lung in 62 participants. Completed in 17 June 2024.
2 February 2024
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 62 |
| Start date | 8 February 2021 |
| Primary completion | 2 February 2024 |
| Estimated completion | 17 June 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Exposure therapy with Virtual Reality.
Conditions studied
- Transplantation, Lung — all drugs for Transplantation, Lung →
- Depression, Anxiety — all drugs for Depression, Anxiety →
- PTSD — all drugs for PTSD →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
18 and older, any sex, with Transplantation, Lung or Depression, Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05125406
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05125406 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille
- Last refreshed: 1 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05125406.
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