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Completed

NCT Number: NCT05125406

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Des Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure therapy with Virtual Reality.

Behavioral

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.

Primary outcomes

  1. Spielberger state trait anxiety inventory for adults

    Time frame: Post-transplant

    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 outcomes

  1. Hospital Anxiety and Depression scale (HADS)

    Time frame: Post-transplant

    The Hospital Anxiety and Depression Scale (HADS) measure anxiety and depression in a general medical population of patients.

  2. The Impact of Event Scale -Revised

    Time frame: Post-transplant

    The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.

  3. Post-traumatic stress disorder Checklist Scale (PCLS)

    Time frame: Post-transplant

    The IES-R is a solid measure of post-trauma phenomena and Posttraumatic Stress Disorder.

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: PIRAT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2021
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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