跳至主要内容
临床试验/NCT03149952
NCT03149952撤回不适用

A Pilot Study of the Feasibility of Setting up a Logbook for Allogeneic Haematopoietic Stem Cell Patients at the University Hospital of Amiens

Centre Hospitalier Universitaire, Amiens0 个研究点开始时间: 2017年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Analysis of the effectiveness of the logbook made available to hospitalized patients in hematology to limit the psychological complications related to the allograft.

研究概览

简要总结

Hospitalization for allogeneic haematopoietic stem cell transplantation constitutes a particular time in the management of patients with malignant hemopathies both for the patient, for his entourage or for the nursing staff. For the patient, the strict protective isolation set up during this period is a source of isolation in the broad sense and is associated with an escape from external events and society. It also constitutes a physical barrier (mask, charlotte, surblouse and overshoes worn by caregivers or visitors) and even psychological in relations with relatives. Moreover, this period is also difficult because of the possible complications of conditioning (mucositis, transit disorders, fever ...) and allograft itself (graft versus host disease, no transplant, relapse disease…). The patient may be weakened and diminished, which can give a feeling of helplessness and uselessness to the family. Finally, this therapy can have serious physical and psychological consequences for the patient and his entourage (especially in the case of family allograft) who do not always have the possibility to express themselves verbally. Published studies in hematology report depressive, anxious and post-traumatic stress disorders in patients and relatives during allogeneic haematopoietic stem cell transplantation. It is therefore important to reduce these symptoms, particularly those related to the cut-off during hospitalization for allogeneic haematopoietic stem cells.

Over the last decade or so, the logbook has been used in some resuscitation services in intubated patients, with the main objective of filling the "memory gap" mentioned by the intubated patients when they woke up and limiting the trauma associated with this Cut in the world corresponding to the sedation period. For this purpose, the use of a logbook in Hematology, by analogy with what is used in the resuscitation services, could be a means of limiting the psychological complications related to the allograft.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
否

入选标准

  • •Major hospitalized patient for allogeneic haematopoietic stem cells
  • •Patient agreeing to participate

排除标准

  • •Patient refusing to participate
  • •Patient hospitalized for reasons other than allogeneic haematopoietic stem cells

研究组 & 干预措施

Patient hospitalized for allogeneic haematopoietic stem cells

Other

干预措施: Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells (Other)

结局指标

主要结局

Analysis of the effectiveness of the logbook made available to hospitalized patients in hematology to limit the psychological complications related to the allograft.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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