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Livskvalitet før og efter transcatheterablation hos børn med arrythmier (QUALICATRYTHM)

15. maj 2026 opdateret af: Hospices Civils de Lyon

Målet med dette kliniske forsøg er at evaluere forbedringen i livskvaliteten efter transcatheterablationen hos børn fra 5 til 17 år gammel lidelse for arrythmia, der har brug for en transcatheterablation (i henhold til PACES -anbefalinger). Det vigtigste spørgsmål er:

• At evaluere en forbedring af livskvaliteten hos disse børn ifølge forskellige spørgeskemaer?

Deltagerne vil besvare nogle spørgeskemaer for at få en global evaluering af livskvaliteten:

  • PEDS QL 4.0
  • PEDS QL 4.0 af proxy, som vil blive afsluttet af forældrene
  • Ricci og Gagnon spørgeskema
  • Børnepression indeks
  • Stat og egenskabsangstbeholdning

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Bron, Frankrig, 69500
        • Rekruttering
        • Hôpital cardiologique Louis Pradel
        • Kontakt:
        • Ledende efterforsker:
          • Francis BESSIERE, PU-PH
      • Le Plessis-Robinson, Frankrig, 92350
        • Rekruttering
        • Hôpital Marie Lannelongue
        • Kontakt:
        • Ledende efterforsker:
          • Alice MALTRET, M.D.
      • Marseille, Frankrig, 13385
        • Rekruttering
        • Hopital De La Timone
        • Kontakt:
        • Ledende efterforsker:
          • Linda KOUTBI, M.D.
      • Paris, Frankrig, 75015
        • Ikke rekrutterer endnu
        • Hopital Necker Enfants Malades
        • Kontakt:
        • Ledende efterforsker:
          • Victor WALDMANN, M.D.
      • Pessac, Frankrig, 33604
        • Ikke rekrutterer endnu
        • Hôpital Cardiologique du Haut Lévêque - Service de cardiologie-électrophysiologie et stimulation cardiaque
        • Kontakt:
        • Ledende efterforsker:
          • Nicolas DERVAL, M.D.
      • Pessac, Frankrig, 33604
        • Ikke rekrutterer endnu
        • Hôpital Cardiologique du Haut Lévêque - Service des maladies cardio-vasculaires congénitales
        • Kontakt:
        • Ledende efterforsker:
          • Marion AUDIE, M.D.
      • Toulouse, Frankrig, 31076
        • Rekruttering
        • Clinique Pasteur
        • Kontakt:
        • Ledende efterforsker:
          • Nicolas COMBES, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Children from 5 to 17 years old suffering from arrythmias with transcathter ablation needed according to PACES recommendation, with medical care in one of the following center :

  • Lyon - HCL - Hôpital cardiologique Louis Pradel
  • Paris - AP HP - Necker enfant malades
  • Plessis Robinson - Hôpital Marie Lannelongue
  • Bordeaux - CHU Bordeaux - Haut Lévesque - Pessac
  • Toulouse - Clinique Pasteur
  • Marseille - AP HM - La Timone

Beskrivelse

Inkluderingskriterier:

  • Patienter i alderen 8 til 17 år
  • Patienter med en rytmeforstyrrelse,
  • Patienter med indikation for kateterablation i henhold til tempo (pædiatriske og medfødte elektrofysiologiske samfund) anbefalinger,
  • Patienter og/eller deres forældre/juridiske værger, der har givet deres ikke-objektion til undersøgelsen.

Ekskluderingskriterier:

  • Afvisning af barn eller forældre/juridiske værger
  • Fantastisk til at forstå og/eller udfylde livskvalitetsspørgeskemaet

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation
Andet: Peds QL 4.0 (Pediatric Quality of Life)
Quality of life questionnaire
Andet: Ricci and Gagnon questionnaire
Physical activity level questionnaire
Andet: State and Trait Inventory
Anxiety questionnaire
Andet: Child Depression Inventory
Depression questionnaire
Andet: PEDS QL 4.0 parents-child
For parents before and after transcatheter ablation. Quality of life questionnaire.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Livskvalitet før og efter transcatheterablation
Tidsramme: 3 måneder efter transcatheterablation

Livskvalitet før og efter transcatheterablation i henhold til livskvalitetsinventar paediatrics (PEDSQL) version 4.0 spørgeskema.

Spørgeskemaet består af 23 spørgsmål, der dækker 4 forskellige områder: fysisk funktion (8 poster), følelsesmæssig funktion (5 poster), social funktion (5 poster) og akademisk funktion (5 poster).

En 5-punkts svarskala bruges på tværs af barnets selvrapport (i alderen 8 til 18) og forælderproxy-rapporter (0 = aldrig et problem; 1 = næsten aldrig et problem; 2 = nogle gange et problem; 3 = ofte et problem; 4 = næsten altid et problem). En 3-punkts skala bruges til det lille barns selvrapportering (i alderen 5 til 7) (0 = slet ikke et problem; 2 = nogle gange et problem; 4 = meget af et problem).

Elementer er omvendt-scorede og transformeres lineært til en 0-100 skala (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), så højere score indikerer en bedre vurdering af sundhedsrelateret livskvalitet.
3 måneder efter transcatheterablation
Livskvalitet før og efter transcatheterablation
Tidsramme: 6 måneder efter transcatheterablation

Livskvalitet før og efter transcatheterablation i henhold til livskvalitetsinventar paediatrics (PEDSQL) version 4.0 spørgeskema.

Spørgeskemaet består af 23 spørgsmål, der dækker 4 forskellige områder: fysisk funktion (8 poster), følelsesmæssig funktion (5 poster), social funktion (5 poster) og akademisk funktion (5 poster).

En 5-punkts svarskala bruges på tværs af barnets selvrapport (i alderen 8 til 18) og forælderproxy-rapporter (0 = aldrig et problem; 1 = næsten aldrig et problem; 2 = nogle gange et problem; 3 = ofte et problem; 4 = næsten altid et problem). En 3-punkts skala bruges til det lille barns selvrapportering (i alderen 5 til 7) (0 = slet ikke et problem; 2 = nogle gange et problem; 4 = meget af et problem).

Elementer er omvendt-scorede og transformeres lineært til en 0-100 skala (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), så højere score indikerer en bedre vurdering af sundhedsrelateret livskvalitet.
6 måneder efter transcatheterablation
Quality of life before and after transcatheter ablation
Tidsramme: 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.
One day before transcatheter ablation
Quality of life before and after transcatheter ablation
Tidsramme: 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.
12 months after transcatheter ablation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Livskvalitet for forældres før og efter transcatheterablation
Tidsramme: 3 måneder efter transcatheterablation

Livskvalitet før og efter transcatheterablation i henhold til PEDSQL version 4.0 forældre-kid spørgeskema

Spørgeskemaet består af 23 spørgsmål, der dækker 4 forskellige områder: fysisk funktion (8 poster), følelsesmæssig funktion (5 poster), social funktion (5 poster) og akademisk funktion (5 poster).

En 5-punkts svarskala bruges på tværs af barnets selvrapport (i alderen 8 til 18) og forælderproxy-rapporter (0 = aldrig et problem; 1 = næsten aldrig et problem; 2 = nogle gange et problem; 3 = ofte et problem; 4 = næsten altid et problem). En 3-punkts skala bruges til det lille barns selvrapportering (i alderen 5 til 7) (0 = slet ikke et problem; 2 = nogle gange et problem; 4 = meget af et problem).

Elementer er omvendt-scorede og transformeres lineært til en 0-100 skala (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), så højere score indikerer en bedre vurdering af sundhedsrelateret livskvalitet.
3 måneder efter transcatheterablation
Livskvalitet for forældres før og efter transcatheterablation
Tidsramme: 6 måneder efter transcatheterablation

Livskvalitet før og efter transcatheterablation i henhold til PEDSQL version 4.0 forældre-kid spørgeskema

Spørgeskemaet består af 23 spørgsmål, der dækker 4 forskellige områder: fysisk funktion (8 poster), følelsesmæssig funktion (5 poster), social funktion (5 poster) og akademisk funktion (5 poster).

En 5-punkts svarskala bruges på tværs af barnets selvrapport (i alderen 8 til 18) og forælderproxy-rapporter (0 = aldrig et problem; 1 = næsten aldrig et problem; 2 = nogle gange et problem; 3 = ofte et problem; 4 = næsten altid et problem). En 3-punkts skala bruges til det lille barns selvrapportering (i alderen 5 til 7) (0 = slet ikke et problem; 2 = nogle gange et problem; 4 = meget af et problem).

Elementer er omvendt-scorede og transformeres lineært til en 0-100 skala (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), så højere score indikerer en bedre vurdering af sundhedsrelateret livskvalitet.
6 måneder efter transcatheterablation
Comparing level of activity before and after transcatheter ablation
Tidsramme: 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).
One day before transcatheter ablation
Comparing level of activity before and after transcatheter ablation
Tidsramme: 3 months after 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).
3 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation
Tidsramme: 6 months after 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).
6 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation
Tidsramme: 12 months after 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).
12 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
Tidsramme: 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.
One day before transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
Tidsramme: 3 months after 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.
3 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
Tidsramme: 6 months after 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.
6 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
Tidsramme: 12 months after 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.
12 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation
Tidsramme: 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.
One day before transcatheter ablation
Comparing level of depression before and after transcatheter ablation
Tidsramme: 3 months after 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.
3 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation
Tidsramme: 6 months after 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.
6 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation
Tidsramme: 12 months after 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.
12 months after transcatheter ablation
Quality of life of parents before and after transcatheter ablation
Tidsramme: 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.
One day before transcatheter ablation
Quality of life of parents before and after transcatheter ablation
Tidsramme: 12 months after 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.
12 months after transcatheter ablation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospices Civils de Lyon

Efterforskere

  • Ledende efterforsker: Francis BESSIERE, PU-PH, Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. september 2025

Primær færdiggørelse (Anslået)

23. marts 2027

Studieafslutning (Anslået)

23. marts 2027

Datoer for studieregistrering

Først indsendt

29. januar 2025

Først indsendt, der opfyldte QC-kriterier

29. januar 2025

Først opslået (Faktiske)

5. februar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 69HCL24_0830
  • 2024-A02568-39 (Anden identifikator: ID-RCB)

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Kliniske forsøg med Peds QL 4.0 (Pediatric Quality of Life)

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