Dagbøger Til Kritisk Syge Patienter Skrevet af pårørende: Betydning for Patient og pårørende Samt Effekt i Forhold Til Udvikling af Symptomer på Posttraumatisk Stress
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
- 否
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
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
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
Anne Højager Nielsen
RN, MCN, ph.d. student
Hospitalsenheden Vest
