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

NCT ID: NCT05125406

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2024-06-17

Brief Summary

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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

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Conditions

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Transplantation, Lung Depression, Anxiety PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exposure therapy using Virtual Reality (ETVR)

Group Type EXPERIMENTAL

Exposure therapy with Virtual Reality.

Intervention Type 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.

No exposure therapy with Virtual Reality.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exposure 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assistance Publique Des Hôpitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2019-16

Identifier Type: -

Identifier Source: org_study_id

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