Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Quality of life before and after transcatheter ablation
研究概览
简要总结
The goal of this clinical trial is to evaluate the improvement in the quality of life after the transcatheter ablation in children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation (according to PACES recommendations). The main question is how to evaluate an improvement in the quality of life in these children, according to different questionnaires?
Participants will answer some questionnaires to get a global evaluation of the quality of life:
- Peds QL 4.0
- Peds QL 4.0 by proxy, which will be completed by the parents
- Ricci and Gagnon questionnaire
- Child Depression Index
- State and Trait Anxiety Inventory
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 5 to 17
- •Patients with a rhythm disorder,
- •Patients with indication for catheter ablation according to PACES (Pediatric and Congenital Electrophysiology Society) recommendations,
- •Patients and/or their parents/legal guardians who have given their non-objection to the study.
排除标准
- •Refusal of child or parents/legal guardians
- •Unability to understand and/or fill the quality of life questionnaire
研究组 & 干预措施
Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation
干预措施: Peds QL 4.0 (Pediatric Quality of Life) (Other)
Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation
干预措施: Ricci and Gagnon questionnaire (Other)
Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation
干预措施: State and Trait Inventory (Other)
Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation
干预措施: Child Depression Inventory (Other)
Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation
干预措施: PEDS QL 4.0 parents-child (Other)
结局指标
主要结局
Quality of life before and after transcatheter ablation
时间窗: One day before transcatheter ablation
Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire. The questionnaire consists of 23 questions covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is used for the young child self-report (ages 5 to 7) (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate a better assessment of health-related quality of life.
Quality of life before and after transcatheter ablation
时间窗: 12 months after transcatheter ablation
Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire. The questionnaire consists of 23 questions covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is used for the young child self-report (ages 5 to 7) (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate a better assessment of health-related quality of life.
Quality of life before and after transcatheter ablation
时间窗: 6 months after transcatheter ablation
Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire. The questionnaire consists of 23 questions covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is used for the young child self-report (ages 5 to 7) (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate a better assessment of health-related quality of life.
Quality of life before and after transcatheter ablation
时间窗: 3 months after transcatheter ablation
Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire. The questionnaire consists of 23 questions covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is used for the young child self-report (ages 5 to 7) (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate a better assessment of health-related quality of life.
次要结局
- Comparing level of activity before and after transcatheter ablation(One day before transcatheter ablation)
- Comparing level of activity before and after transcatheter ablation(3 months after transcatheter ablation)
- Comparing level of activity before and after transcatheter ablation(6 months after transcatheter ablation)
- Comparing level of activity before and after transcatheter ablation(12 months after transcatheter ablation)
- Comparing level of anxiety before and after transcatheter ablation(One day before transcatheter ablation)
- Comparing level of anxiety before and after transcatheter ablation(3 months after transcatheter ablation)
- Comparing level of anxiety before and after transcatheter ablation(6 months after transcatheter ablation)
- Comparing level of anxiety before and after transcatheter ablation(12 months after transcatheter ablation)
- Comparing level of depression before and after transcatheter ablation(One day before transcatheter ablation)
- Comparing level of depression before and after transcatheter ablation(3 months after transcatheter ablation)
- Comparing level of depression before and after transcatheter ablation(6 months after transcatheter ablation)
- Comparing level of depression before and after transcatheter ablation(12 months after transcatheter ablation)
- Quality of life of parents before and after transcatheter ablation(One day before transcatheter ablation)
- Quality of life of parents before and after transcatheter ablation(12 months after transcatheter ablation)
- Quality of life of parents before and after transcatheter ablation(6 months after transcatheter ablation)
- Quality of life of parents before and after transcatheter ablation(3 months after transcatheter ablation)