Bad News- Diagnosis: Epilepsy in Childhood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- perception of physicians advisory skills with respect to actual distress
研究概览
简要总结
"Bad news" are defined as"any information which adversely and seriously affects an individuals' view of future. Families of chronic ill children are exposed to a high stress load. This project is to investigate the stress burden directly after diagnosis of epilepsy in childhood and coping capabilities in the course of time and how quality of communication at the time of diagnosis effects stress perception and coping behaviour in the following 12 months.
Perceived/ experienced advisory skills of the physician will be assessed by parents and children (older than eleven) on the basis of SPIKES - a Six-Step Protocol for Delivering Bad News.
The subjective perception regarding quality of dialogue in relationship to childrens and their parents quality of life and their coping strategies will be assessed.
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
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed epilepsy (according to International League Against Epilepsy (ILAE) criteria):
- •at least two unprovoked epileptic fits at intervals of at least 24 hours or
- •one unprovoked epileptic fit and a recurrence risk of at least 60% or
- •epilepsy syndrome
排除标准
- •children with intensive care treatment as inpatients
- •parents with insufficient German language capabilities
- •parents and children with exposure to traumatic events in the past three months that could probably lead to post traumatic distress (loss of a loved person, severe traffic accident, raid, violence, sexual assault, war)
结局指标
主要结局
perception of physicians advisory skills with respect to actual distress
时间窗: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Evaluation with Six-Step Protocol for Delivering Bad News (SPIKES); enables the physician to fulfill the four most important objectives of the interview disclosing bad news: gathering information from the patient, transmitting the medical information, providing support to the patient, and eliciting the patient's collaboration in developing a strategy or treatment plan for the future.
次要结局
- Change in Stress and Coping Inventory (SCI)(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)
- Change in Stress Coping Style Questionnaire (SVF) 78/78-S(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)
- Change in Parenting Stress Index (PSI)(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)
- Change in National Comprehensive Cancer Network (NCCN) thermometer(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)
- Change in Adult-Self-Report for Ages 18- 59 (ASR 18-59)(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)
- Change in Pediatric Quality of Life Inventory (Peds-QL)(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)
- Questionnaire on the assessment of stress and stress management in Childhood and Adolescence Revision (SSKJ 3-8 R)(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)
- Child behaviour checklist (CBCL)(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)
- Pediatric Quality of Life Inventory (PedsQL 4.0)(1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child)