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临床试验/NCT03736954
NCT03736954已完成不适用

Pilot Study of ICU Doulas Providing Psychological Support Based on Positive Suggestions to Mitigate Psychological and Cognitive Sequelae of Critical Illness

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年11月12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
Mayo Clinic
入组人数
42
试验地点
2
主要终点
feasibility of integration of trained doulas into the ICU

研究概览

简要总结

Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. Research on the formation of fear and associated memories shows that if mitigating information about a traumatic event is introduced during the time between memory formation and its recall, the emotional experience of the memory can be modified in a positive manner. This means that in order to prevent mental health problems in critical illness survivors, psychological support needs to take place in parallel with medical treatment in the ICU. The Researchers hypothesize that early psychological support for the critically ill can decrease mental health morbidity in critical illness survivors. However, providing consistent psychological support intervention is a challenge for busy ICU clinicians. It is not feasible to hire behavioral medicine trained psychologists to become permanent ICU staff nationwide. Doulas, trained lay health care providers who provide emotional support to women in labor, have been identified as reliable yet affordable alternative. Given common elements of their services and our intervention, doulas are in an ideal position to administer early psychological support. The objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the ICU. This will be accomplished by training doulas in providing standardized psychological support intervention and refining the intervention based on stakeholder feedback

研究设计

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

  • adults (age >18) admitted to the ICU requiring intubation or vasopressors and expected to stay >48 hours.

排除标准

  • history of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy;
  • patients on comfort care;
  • patients not expected to survive the hospital stay
  • non-English speaking, deaf or mute
  • prisoners

结局指标

主要结局

feasibility of integration of trained doulas into the ICU

时间窗: 6 months

pilot feasibility study. Feasibility defined as ICU doulas being able to perform study intervention on 30 recruited patients for at least 10 minutes daily throughout patient's ICU course.

次要结局

  • Patient scores on Impact of Events Scale - Revised(6 months)
  • Patient scores on Hospital Anxiety and Depression Scale(6 months)
  • Patient scores on Montreal Cognitive Assessment-blind(6 months)
  • Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients(6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lioudmila Karnatovskaia

assistant professor

Mayo Clinic

研究点 (2)

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