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临床试验/NCT05125406
NCT05125406已完成不适用

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

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Spielberger state trait anxiety inventory for adults

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 years
  • Registration on the lung transplant waiting list
  • Signature of consent

排除标准

  • 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

结局指标

主要结局

Spielberger state trait anxiety inventory for adults

时间窗: 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.

次要结局

  • Hospital Anxiety and Depression scale (HADS)(Post-transplant)
  • Post-traumatic stress disorder Checklist Scale (PCLS)(Post-transplant)
  • The Impact of Event Scale -Revised(Post-transplant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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