Assessment of Pain in People With Thalassemia (Pain)
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G 2C4
- Toronto General Hospital
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California
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Oakland、California、美国、94609
- Children's Hospital and Research Institute at Oakland
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Georgia
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Atlanta、Georgia、美国、30342
- Children's Healthcare of Atlanta
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Illinois
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Chicago、Illinois、美国、60614
- Children's Memorial Hospital of Chicago
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Massachusetts
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Boston、Massachusetts、美国、02115
- Children's Hospital of Boston
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New York
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New York、New York、美国、10065
- Weill Medical College
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Children's Hospital of Philadelphia
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Texas
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Houston、Texas、美国、77030
- Baylor College of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Prevalence of Pain
大体时间:Measured at Month 9
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Measured at Month 9
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次要结果测量
结果测量 |
大体时间 |
---|---|
Common Sites of Pain
大体时间:Measured at Month 9
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Measured at Month 9
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Pain Occurrence by Age
大体时间:Measured at Month 9
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Measured at Month 9
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Impact of Pain on Functioning and Well-being
大体时间:Measured at Month 9
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Measured at Month 9
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合作者和调查者
调查人员
- 首席研究员:Jeanne Boudreeaux, MD、Children's Healthcare of Atlanta
- 首席研究员:Brigitta Mueller, MD、Baylor College of Medicine at Houston
- 学习椅:Dru Foote, RN, NP、Children's Hospital and Research Institute of Oakland
- 首席研究员:Patricia Giardina, MD、Weill Medical College of Cornell
- 首席研究员:Janet Kwiatkowski, MD、Children's Hospital of Philadelphia
- 首席研究员:Nancy Olivieri, MD、Toronto General Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 639
- U01HL065238 (美国 NIH 拨款/合同)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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