Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit (CessataEl'ansi)
調査の概要
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：Julie Oncle, MD
- 電話番号：33+03 22 45 64 43
- メール：Oncle.julie@chu-amiens.fr
研究場所
-
-
-
Amiens、フランス、80480
- CHRU Amiens
-
主任研究者：
- Brassaint, MD
-
主任研究者：
- Anne VANBESIEN, MD
-
主任研究者：
- Sophie RIVENQ, MD
-
主任研究者：
- Isabelle QUENTIN, MD
-
主任研究者：
- Laurence BIRKUI, MD
-
主任研究者：
- MEROT, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age > 18 years
- Patient hospitalized in palliative care unit for oncological pathology
- Presenting an anxiety score > 46 (according to the STAI-Y State scale)
- Whose subsequent hospitalization is estimated to last more than three weeks
- No deafness likely to interfere with a receptive music therapy session (no difficulty in understanding whispered speech).
- Affiliated with a social security scheme
- Have signed the consent form for the study
Exclusion Criteria:
- Deafness without hearing aids
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding
- Not affiliated to a social security scheme
- Patient with an aversion to the sounds produced by the Kigonki
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
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Group without music therapy
|
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Assessment of PANAS questionnaire, TSAI test, digital scale measurement, physiological constants (pulse, blood pressure, respiratory rate) 3 times a week for 2 weeks, then 7 days after the last of these 6 assessments.
|
|
実験的：Music therapy group
Tri-weekly assessments will be repeated 30 minutes after each ISM session. - Evaluation of quality of life at last assessment |
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Assessment of PANAS questionnaire, TSAI test, digital scale measurement, physiological constants (pulse, blood pressure, respiratory rate) 3 times a week for 2 weeks, then 7 days after the last of these 6 assessments.
Six 30-minute sessions of receptive ISM with Kigonki according to study protocol
|
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 |
|---|---|---|
|
change in anxiety score obtained using the STAI-Y State scale
時間枠：1 week
|
The State-Trait Anxiety Inventory (STAI), specifically Form Y (STAI-Y), stands as one of the most widely utilized self-report measures in psychological and medical research for the quantitative assessment of anxiety. The STAI-Y operationalizes the psychological construct of anxiety as having two independent dimensions, each measured by 20 items for a total of 40 items in the complete inventory. State Anxiety (A-State) is defined as a transient emotional response characterized by immediate, subjective feelings of tension, apprehension, worry, and physiological activation of the autonomic nervous system. Respondents assess their feelings "right now, at this moment" using a 4-point intensity scale. In contrast, Trait Anxiety (A-Trait) refers to stable individual differences in anxiety proneness. Individuals scoring high in A-Trait are predisposed to perceive a broader range of situations as threatening and are likely to react to these situations with elevated A-State responses. A-Trait |
1 week
|
|
change in anxiety score obtained using the STAI-Y State scale
時間枠：2 weeks
|
The State-Trait Anxiety Inventory (STAI), specifically Form Y (STAI-Y), stands as one of the most widely utilized self-report measures in psychological and medical research for the quantitative assessment of anxiety. The STAI-Y operationalizes the psychological construct of anxiety as having two independent dimensions, each measured by 20 items for a total of 40 items in the complete inventory. State Anxiety (A-State) is defined as a transient emotional response characterized by immediate, subjective feelings of tension, apprehension, worry, and physiological activation of the autonomic nervous system. Respondents assess their feelings "right now, at this moment" using a 4-point intensity scale. In contrast, Trait Anxiety (A-Trait) refers to stable individual differences in anxiety proneness. Individuals scoring high in A-Trait are predisposed to perceive a broader range of situations as threatening and are likely to react to these situations with elevated A-State responses. A-Trait |
2 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
PANAS questionnaire (Positive and Negative Affect Scale)
時間枠：30 minutes after the session
|
30 minutes after the session
|
|
Variations in scores of the STAI-Y ETAT scale
時間枠：30 minutes after the session
|
30 minutes after the session
|
|
pulse variation
時間枠：30 minutes after the session
|
30 minutes after the session
|
|
BP variation
時間枠：30 minutes after the session
|
30 minutes after the session
|
|
respiratory rate
時間枠：30 minutes after the session
|
30 minutes after the session
|
|
PANAS questionnaire (Positive and Negative Affect Scale)
時間枠：one week after the 6th session
|
one week after the 6th session
|
|
Variations in scores of the STAI-Y ETAT scale
時間枠：one week after the 6th session
|
one week after the 6th session
|
|
pulse variation
時間枠：one week after the 6th session
|
one week after the 6th session
|
|
BP variation
時間枠：one week after the 6th session
|
one week after the 6th session
|
|
respiratory rate
時間枠：one week after the 6th session
|
one week after the 6th session
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。