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临床试验/NCT03721770
NCT03721770已完成不适用

Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation: an Observational, Prospective Study

frederic ADNET1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2015年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Score ≥ 33 on the Impact of Event Scale - Revised.

研究概览

简要总结

The fight against the scarcity of grafts is a major public health issue in France. Despite a very good success rate of transplants from brain-dead donors or living donors, the waiting time for transplantation continues to increase, leading to morbidity and mortality, as well as medical costs. Since 2005, the BioMedicine Agency has implemented a protocol authorizing kidney and liver samples taken from deceased donors after cardiac arrest (DDAC). This type of sampling has become a common practice in several regions of France and Europe. In case of DDAC, the sampling protocol poses a significant temporal constraint, since the patient must be taken within 6 hours after the cardiac arrest. This constraint leads to a specific organization of the announcement of the death and the request for non-opposition to the levy.

The brutal loss of a loved one is a potentially traumatic experience for family members. The manifestations of the pathological components of mourning such as post-traumatic stress disorder, anxio-depressive syndrome, pathological bereavement, are often expressed early in the first year after the death of the loved one. Families of organ donor patients probably represent a population at high risk for the expression of psychiatric conditions such as post-traumatic stress disorder or pathological bereavement. The limited time available to prepare relatives to make a decision could promote the expression of psychiatric morbidity in the short or medium term. The data on this new transplantation procedure and its psychological consequences are insufficient, and we consider that if a state of post-traumatic stress occurred in more than 50% of parents, the procedure of announcement would be reviewed. The purpose of this study is to test this hypothesis.

Most of the work on relatives of potential organ donors has focused on procedures for brain death. Most of this work has focused on characterizing the determinants of acceptance or refusal of organ donation in the family. The literature relating to the follow-up of relatives of a patient after organ donation is very poor: very few studies have focused on the psychological consequences and / or the psychological state of this population in the period post-death. In addition, very few qualitative and quantitative studies make it possible to evaluate the appearance of psychopathological manifestations related to the announcement of death simultaneously with a request for organ removal. This research, therefore, will make it possible to estimate the possible psychological impact on the bereaved family as well as an assessment of the psychological state. A mixed methodology (quantitative and qualitative) will make it possible to highlight explanatory factors of the quantitative results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Parent or adult companion of a patient who died of cardiac arrest after organ removal (Inclusion order of priority is husband-wife / father-mother / son-daughter)
  • Only one loved one is included per patient.

排除标准

  • Age < 18 years
  • Refusal to participate in the study
  • Difficulty in communication (foreign, language, etc)

结局指标

主要结局

Score ≥ 33 on the Impact of Event Scale - Revised.

时间窗: 3 months

Percentage of relatives with post-traumatic stress disorder at 3 months with a score ≥ 33 on the Impact of Event Scale - Revised. The Impact of Event Scale - Revised measures symptoms of intrusion, avoidance, numbing and hyperarousal with respect to a particular life-threatening event. Subscales of the scale: Intrusion scale (range 0-24 score); avoidance scale (range 0-26 score); hyperarousal scale (range 0-18 score. Range of the scale 0-88 scores. Score 24 and more: PTSD is a clinical concern. Score 33 and above : This represents the best cutoff for a probable diagnosis of PTSD Score 37 and more : This is high enough to suppress the immune system's functioning (even 10 years after an impact event).

次要结局

  • Post Traumatic Stress Disorder Diagnosis And Major Depressive Episode Diagnosis (Mini International Neuropsychiatric Interview - Version 5.0.0 Module I. Post Traumatic Stress Disorder and Module A. Major Depressive Episode)(3 months et 1 year)
  • Score of depression and anxiety (Hospital of Anxiety and Depression Scale).(3 months and 1 year)
  • Score of pathological mourning (Inventory of Complicated Grief)(1 year)

研究者

发起方
frederic ADNET
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

frederic ADNET

MD, PhD

Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence

研究点 (1)

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