跳至主要内容
临床试验/NCT02357680
NCT02357680已完成不适用

Dagbøger Til Kritisk Syge Patienter Skrevet af pårørende: Betydning for Patient og pårørende Samt Effekt i Forhold Til Udvikling af Symptomer på Posttraumatisk Stress

Hospitalsenheden Vest4 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2015年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
189
试验地点
4
主要终点
PTSS-14 (Post Traumatic Stress Symptoms)

研究概览

简要总结

This study will investigate the effect of diaries written by relatives for critically ill patients on the risk of posttraumatic stress symptoms.

Utilizing a randomized controlled design pairs of one patient and one relative will be assigned to either diary intervention or standard care. The effect of the diary will be evaluated using a questionnaire 3 months post charge.

The results of this study will add to the body of knowledge on how diaries may help critical care survivors and their relatives to proceed with their lives.

详细描述

Diaries written for critically ill patients has previously been shown to protect patient and relatives from new cases of post traumatic stress (Jones et al. 2010, Jones et al. 2012, Garrouste-Orgeas 2012). Furthermore it has been described how relatives and patients use diaries written by nurses to process the time they stayed in the intensive care unit (Egerod et al. 2011). This study will investigate if there is a similar effect, when relatives write the diary for the critically ill patient instead of nurses doing it as patients find it very valuable when relatives has contributed to the diary or when relatives presence has been documented in the diary (Engström et al. 2009).

The investigators hypothesis is that a diary written by relatives for critically ill patients will reduce the risk of developing symptoms of post traumatic stress in relatives and patients.

Design: randomized controlled study. Relative and patient are randomized as a pair to either intervention group (diary intervention) or control group (standard care). Relatives will be recruited to the study while the patient is critically ill in the ICU, the patient will be recruited when he or she is able to receive information about the study.

Intervention: Nurses guide the nearest relative (spouse, partner, child, parent or friend) to write a diary during the patients stay in the ICU and up to a month post discharge. The diary is a notebook which also contains a written instruction on how to write and use the diary during and after the time in the intensive care unit. At least two photographs of the patient is taken by the staff and added to the diary upon the patients consent.

Blinding: Due to the nature of the intervention neither caregivers nor participants can be blinded to the intervention. However, steps will be taken to ensure that the outcomes assessor is blinded.

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
Single (Outcomes Assessor)

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

  • Expected to stay in ICU > 48 hours
  • Expected to be on ventilator > 24 hours
  • Has a close relative > 18 years old
  • Speaking and understanding Danish.
  • Expected to be able to deliver an informed consent later
  • *Speaking and understanding Danish
  • Relative and patient are included in the study as a pair.

排除标准

  • Patient staying less than 48 hours in ICU
  • Patient less than 24 hours on ventilator
  • Patient not able to give an informed consent to participate in study or patient dies in ICU (both relative and patient are excluded).

研究组 & 干预措施

Intervention group

Experimental

Relatives randomized to the intervention group is provied with a diary. Nurses advice relatives on how to write and use the diary under and after the patients stay in the ICU. A written description on how to use the diary is also provided.

At least two photographs of the patient is taken by nurses. Photographs will first be included in the diary when full consent from the patient has been obtained.

Patients and relatives recieve a questionaire 3 months after the patient has been dismissed from the ICU.

干预措施: Diary (Other)

Control group

No Intervention

Standard Care. Patients and relatives recieve a questionaire 3 months after the patient has been dismissed from the ICU.

结局指标

主要结局

PTSS-14 (Post Traumatic Stress Symptoms)

时间窗: 3 months post discharge from ICU

14 items inventory covering all symptoms of PTSD.

次要结局

  • HADS (Hospital Anxiety and Depression Scale)(3 months post discharge from ICU)
  • SF-36(3 months post discharge from ICU)

研究者

发起方
Hospitalsenheden Vest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Højager Nielsen

RN, MCN, ph.d. student

Hospitalsenheden Vest

研究点 (4)

Loading locations...

相似试验