Arrhythmia
Conditions
Keywords
children, arrythmia, transcatheter ablation, quality of life
Brief summary
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
Interventions
OTHERPeds QL 4.0 (Pediatric Quality of Life)
Quality of life questionnaire
OTHERRicci and Gagnon questionnaire
Physical activity level questionnaire
OTHERState and Trait Inventory
Anxiety questionnaire
OTHERChild Depression Inventory
Depression questionnaire
OTHERPEDS QL 4.0 parents-child
For parents before and after transcatheter ablation. Quality of life questionnaire.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Refusal of child or parents/legal guardians * Unability to understand and/or fill the quality of life questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life before and after transcatheter ablation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing level of activity before and after transcatheter ablation | One day before transcatheter ablation | Level of activity before and after transcatheter ablation according to to the Ricci and Gagnon questionnaire. The self-assessment questionnaire is used to determine the patient's activity profile: inactive, active or very active. It consists of 9 questions with 5 suggested answers (giving a score from 1 to 5 for each answer given). The higher the score, the more active the profile (Less than 18 points in total: Inactive, Between 18 and 35 points in total: Active, More than 35 points in total: Very active). |
| Comparing level of anxiety before and after transcatheter ablation | One day before transcatheter ablation | Level of anxiety before and after transcatheter ablation according to the State-Trait Anxiety Inventory for Children (STAIC) questionnaire. The STAIC comprises 2 series of 20 items each: one concerns anxiety as a 'personality trait'; the other series concerns the subject's 'state of anxiety' at the time of completing the questionnaire, which may fluctuate over time. Each item is rated on a scale of 1 to 3. The overall score is obtained by a simple sum. The overall score varies between 20 and 60. The threshold score defining pathological anxiety is 34. The higher the score, the more anxious the patient. |
| Comparing level of depression before and after transcatheter ablation | One day before transcatheter ablation | Level of depression before and after transcatheter ablation according to the Child Depression Inventory (CDI) questionnaire. This questionnaire measures the intensity of depression in children and adolescents aged 7 to 17. Each item is scored from 0 (normal behaviour for age or absent) to 2 (severe). Adding the items together gives a total score of between 0 and 54. The higher the score, the more pathological the condition. |
| Quality of life of parents before and after transcatheter ablation | One day before transcatheter ablation | Quality of life before and after transcatheter ablation according to PedsQL version 4.0 parents-kid 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. |
Countries
France
Contacts
CONTACTFrancis BESSIERE, PU-PH
CONTACTNawel BABOURI
PRINCIPAL_INVESTIGATORFrancis BESSIERE, PU-PH
Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie
Outcome results
None listed