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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Transplantation, Lung
PTSD
Depression, Anxiety

Treatments

Behavioral: Exposure therapy with Virtual Reality.

Study type

Interventional

Funder types

Other

Identifiers

NCT05125406
2019-16

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Exposure therapy using Virtual Reality (ETVR)
Experimental group
Treatment:
Behavioral: Exposure therapy with Virtual Reality.
No exposure therapy with Virtual Reality.
No Intervention group

Trial contacts and locations

1

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Central trial contact

BENJAMIN COIFFARD, MD; EMILIE GARRIDO-PRADALIE, Study Director

Data sourced from clinicaltrials.gov

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