Arrythmiasの子供たちの経カテーテルアブレーションの前後の生活の質 (QUALICATRYTHM)
この臨床試験の目標は、経カテーテルのアブレーションを必要とするアリスミアの5〜17歳の子供の経カテーテルアブレーション後の生活の質の改善を評価することです(ペースの推奨に従って)。 主な質問は次のとおりです。
•さまざまなアンケートに従って、これらの子供たちの生活の質の改善を評価するために?
参加者は、生活の質のグローバルな評価を得るためにいくつかのアンケートに答えます。
- PEDS QL 4.0
- PED QL 4.0は、両親によって完成されます。
- リッチとガニョンのアンケート
- 児童うつ病指数
- 状態および特性不安インベントリ
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Francis BESSIERE, PU-PH
- 電話番号:+33 04 72 35 75 65
- メール:francis.bessiere@chu-lyon.fr
研究連絡先のバックアップ
- 名前:Nawel BABOURI
- 電話番号:+33 04 26 73 93 83
- メール:nawel.babouri@chu-lyon.fr
研究場所
-
-
-
Bron、フランス、69500
- 募集
- Hôpital Cardiologique Louis Pradel
-
コンタクト:
- Francis BESSIERE, PU-PH
- 電話番号:+33 04 72 35 75 65
- メール:francis.bessiere@chu-lyon.fr
-
主任研究者:
- Francis BESSIERE, PU-PH
-
Le Plessis-Robinson、フランス、92350
- 募集
- Hôpital Marie Lannelongue
-
コンタクト:
- Alice MALTRET, M.D
- 電話番号:+33 01 40 94 25 45
- メール:alice.maltret@gmail.com
-
主任研究者:
- Alice MALTRET, M.D.
-
Marseille、フランス、13385
- 募集
- Hôpital de la Timone
-
コンタクト:
- Linda KOUTBI, M.D.
- 電話番号:+33 04 91 38 65 75
- メール:Rita.KOUTBI@ap-hm.fr
-
主任研究者:
- Linda KOUTBI, M.D.
-
Paris、フランス、75015
- まだ募集していません
- Hôpital Necker Enfants malades
-
コンタクト:
- Victor WALDMANN, M.D.
- 電話番号:+33 01 44 49 43 44
- メール:victor.waldmann@aphp.fr
-
主任研究者:
- Victor WALDMANN, M.D.
-
Pessac、フランス、33604
- まだ募集していません
- Hôpital Cardiologique du Haut Lévêque - Service de cardiologie-électrophysiologie et stimulation cardiaque
-
コンタクト:
- Nicolas DERVAL, M.D.
- メール:nicolas.derval@chu-bordeaux.fr
-
主任研究者:
- Nicolas DERVAL, M.D.
-
Pessac、フランス、33604
- まだ募集していません
- Hôpital Cardiologique du Haut Lévêque - Service des maladies cardio-vasculaires congénitales
-
コンタクト:
- Marion AUDIE, M.D.
- メール:marion.audie@chu-bordeaux.fr
-
主任研究者:
- Marion AUDIE, M.D.
-
Toulouse、フランス、31076
- 募集
- Clinique Pasteur
-
コンタクト:
- Nicolas COMBES, M.D.
- 電話番号:+33 05 62 21 16 45
- メール:ncombes@clinique-pasteur.com
-
主任研究者:
- Nicolas COMBES, M.D.
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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
説明
包含基準:
- 8〜17歳の患者
- リズム障害のある患者、
- ペース(小児および先天性電気生理学協会)の推奨に応じたカテーテルアブレーションの適応患者、推奨
- 患者および/またはその研究に非拒否を与えた両親/法的保護者。
除外基準:
- 子供または両親/法的保護者の拒否
- 生活の質のアンケートを理解および/または埋める不可能
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation
|
Quality of life questionnaire
Physical activity level questionnaire
Anxiety questionnaire
Depression questionnaire
For parents before and after transcatheter ablation.
Quality of life questionnaire.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
経カテーターアブレーションの前後の生活の質
時間枠:経カテーテルアブレーションの3か月後
|
life of Life inventory Paediatrics(PEDSQL)バージョン4.0アンケートに従って、経カテーテルのアブレーション前後の生活の質。 アンケートは、4つの異なる領域をカバーする23の質問で構成されています:物理機能(8項目)、感情機能(5項目)、社会的機能(5項目)、および学術機能(5項目)。 5ポイントの応答スケールは、子供の自己報告(8〜18歳)および親代理レポート(0 =決して問題ではない; 1 =ほとんど問題にならない; 2 =時々問題、3 =多くの場合問題; 4 =ほとんど常に問題)。 3ポイントスケールは、幼い子供の自己報告(5〜7歳)に使用されます(0 =まったく問題ではありません; 2 =時々問題、4 =多くの問題)。 アイテムはリバーススコアであり、0-100スケール(0 = 100、1 = 75、2 = 50、3 = 25、4 = 0)に直線的に変換されるため、より高いスコアは健康関連の生活の質のより良い評価を示しています。 |
経カテーテルアブレーションの3か月後
|
|
経カテーターアブレーションの前後の生活の質
時間枠:経カテーテルアブレーションの6か月後
|
life of Life inventory Paediatrics(PEDSQL)バージョン4.0アンケートに従って、経カテーテルのアブレーション前後の生活の質。 アンケートは、4つの異なる領域をカバーする23の質問で構成されています:物理機能(8項目)、感情機能(5項目)、社会的機能(5項目)、および学術機能(5項目)。 5ポイントの応答スケールは、子供の自己報告(8〜18歳)および親代理レポート(0 =決して問題ではない; 1 =ほとんど問題にならない; 2 =時々問題、3 =多くの場合問題; 4 =ほとんど常に問題)。 3ポイントスケールは、幼い子供の自己報告(5〜7歳)に使用されます(0 =まったく問題ではありません; 2 =時々問題、4 =多くの問題)。 アイテムはリバーススコアであり、0-100スケール(0 = 100、1 = 75、2 = 50、3 = 25、4 = 0)に直線的に変換されるため、より高いスコアは健康関連の生活の質のより良い評価を示しています。 |
経カテーテルアブレーションの6か月後
|
|
Quality of life before and after transcatheter ablation
時間枠: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
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
経カテーテルアブレーションの前後の親の生活の質
時間枠:経カテーテルアブレーションの3か月後
|
PEDSQLバージョン4.0親KIDアンケートに従って、経カテーテルのアブレーション前後の生活の質 アンケートは、4つの異なる領域をカバーする23の質問で構成されています:物理機能(8項目)、感情機能(5項目)、社会的機能(5項目)、および学術機能(5項目)。 5ポイントの応答スケールは、子供の自己報告(8〜18歳)および親代理レポート(0 =決して問題ではない; 1 =ほとんど問題にならない; 2 =時々問題、3 =多くの場合問題; 4 =ほとんど常に問題)。 3ポイントスケールは、幼い子供の自己報告(5〜7歳)に使用されます(0 =まったく問題ではありません; 2 =時々問題、4 =多くの問題)。 アイテムはリバーススコアであり、0-100スケール(0 = 100、1 = 75、2 = 50、3 = 25、4 = 0)に直線的に変換されるため、より高いスコアは健康関連の生活の質のより良い評価を示しています。 |
経カテーテルアブレーションの3か月後
|
|
経カテーテルアブレーションの前後の親の生活の質
時間枠:経カテーテルアブレーションの6か月後
|
PEDSQLバージョン4.0親KIDアンケートに従って、経カテーテルのアブレーション前後の生活の質 アンケートは、4つの異なる領域をカバーする23の質問で構成されています:物理機能(8項目)、感情機能(5項目)、社会的機能(5項目)、および学術機能(5項目)。 5ポイントの応答スケールは、子供の自己報告(8〜18歳)および親代理レポート(0 =決して問題ではない; 1 =ほとんど問題にならない; 2 =時々問題、3 =多くの場合問題; 4 =ほとんど常に問題)。 3ポイントスケールは、幼い子供の自己報告(5〜7歳)に使用されます(0 =まったく問題ではありません; 2 =時々問題、4 =多くの問題)。 アイテムはリバーススコアであり、0-100スケール(0 = 100、1 = 75、2 = 50、3 = 25、4 = 0)に直線的に変換されるため、より高いスコアは健康関連の生活の質のより良い評価を示しています。 |
経カテーテルアブレーションの6か月後
|
|
Comparing level of activity before and after transcatheter ablation
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Francis BESSIERE, PU-PH、Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 69HCL24_0830
- 2024-A02568-39 (その他の識別子:ID-RCB)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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