Assessment of Pain in People With Thalassemia (Pain)
調査の概要
状態
条件
詳細な説明
Thalassemia is an inherited blood disorder in which the body makes an abnormal form of hemoglobin-the protein in red blood cells that carries oxygen. People with thalassemia often experience fatigue, shortness of breath, and pain. Recent medical advances in treating people with thalassemia who receive regular blood transfusions-a standard procedure that refreshes the healthy red blood supply-have resulted in increased life spans for these people. However, with the extended life spans have come additional issues, including pain. There have been no previous research studies that have examined pain levels in people with thalassemia, and as a result, the sources and prevalence of pain remain unknown. The purpose of this study is to assess the prevalence and severity of pain, common pain sites, and the impact of pain on functioning and well-being in people with thalassemia who receive regular blood transfusions and people with thalassemia who do not receive regular blood transfusions.
This study will enroll people with transfusion-dependant thalassemia and people with non-transfusion-dependant thalassemia. At a baseline study visit, participants will complete a demographic questionnaire and a pain assessment questionnaire. At Months 3, 6, and 9, study researchers will telephone participants to go over the same pain assessment questionnaire again.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Oakland、California、アメリカ、94609
- Children's Hospital and Research Institute at Oakland
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Georgia
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Atlanta、Georgia、アメリカ、30342
- Children's Healthcare of Atlanta
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Illinois
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Chicago、Illinois、アメリカ、60614
- Children's Memorial Hospital of Chicago
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Children's Hospital of Boston
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New York
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New York、New York、アメリカ、10065
- Weill Medical College
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Children's Hospital of Philadelphia
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Texas
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Houston、Texas、アメリカ、77030
- Baylor College of Medicine
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-
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Ontario
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Toronto、Ontario、カナダ、M5G 2C4
- Toronto General Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
Thalassemia, as documented by clinical diagnosis, including the following:
- B-thalassemia (intermedia or major)
- Hgb H disease
- Hgb H with non-deletional mutations (e.g., Hgb H Constant Spring)
- E-B-thalassemia
- Homozygous alpha thalassemia
- Other thalassemic conditions not explicitly excluded
- Thalassemia intermedia due to heterozygous B mutation with an alpha excess
- Participants can be of any race, ethnicity, and either gender.
Exclusion Criteria:
- Thalassemia trait (i.e., single recessive B gene mutation, 2 gene alpha mutation) and thalassemia Hgb S, C, or D compound heterozygotes
- Unwillingness or inability to complete the Brief Pain Inventory (BPI) on a quarterly basis
- Has had a successful bone marrow transplant
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
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
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transfusion-dependant
People with transfusion-dependant thalassemia who received at least 8 transfusions in the past year.
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non-transfusion-dependant
People with non-transfusion-dependant thalassemia who received no transfusions in the past year.
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intermittently transfused
Intermittently transfused patients- individuals who received at least one but fewer than eight transfusions in the last year
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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 |
時間枠 |
---|---|
Prevalence of Pain
時間枠:Measured at Month 9
|
Measured at Month 9
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Common Sites of Pain
時間枠:Measured at Month 9
|
Measured at Month 9
|
Pain Occurrence by Age
時間枠:Measured at Month 9
|
Measured at Month 9
|
Impact of Pain on Functioning and Well-being
時間枠:Measured at Month 9
|
Measured at Month 9
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Jeanne Boudreeaux, MD、Children's Healthcare of Atlanta
- 主任研究者:Brigitta Mueller, MD、Baylor College of Medicine at Houston
- スタディチェア:Dru Foote, RN, NP、Children's Hospital and Research Institute of Oakland
- 主任研究者:Patricia Giardina, MD、Weill Medical College of Cornell
- 主任研究者:Janet Kwiatkowski, MD、Children's Hospital of Philadelphia
- 主任研究者:Nancy Olivieri, MD、Toronto General Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 639
- U01HL065238 (米国 NIH グラント/契約)
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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