痉挛性发声困难访谈
痉挛性发声困难患者的社会经济影响和肉毒杆菌毒素的作用
Previous research has shown that patients with voice disorders often have a lower quality of life and struggle with employment. Spasmodic Dysphonia (SD) is a voice disorder that causes abrupt and uncontrollable spasms of the voice box, often resulting in the person having lifelong changes in their voice and speech pattern. The current mainstay of treatment is injecting botulinum toxin (BT) injections into the vocal cord to ease the spasms. The same research team conducted a pilot study in April 2021 on patients with SD. The pilot study used questionnaires and short interviews to understand the livelihood of 10 SD patients. It displayed that SD may impact patients' quality of life. The investigators now aim to run an official research project, ethically approved, to explore the following questions further:
- Does SD impact the socio-economic lives of its patients? If so, how?
- What role does BT play in the socio-economic livelihood of SD patients?
To answer these questions, the investigators aim to interview 20 patients with Spasmodic Dysphonia.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Manchester、英国
- Manchester University NHS Foundation Trust
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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
Adult patients with diagnosed Spasmodic Dysphonia
描述
Inclusion Criteria:
- Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection.
Exclusion Criteria:
- Below 18 years of age; additional laryngeal condition(s) severely affecting voice.
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Spasmodic Dysphonia patients
Adults diagnosed with Spasmodic Dysphonia who have received at least one botulinum toxin injection. |
Botulinum toxin injection to ease spasms of vocal cord |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Does Spasmodic Dysphonia impact the socio-economic lives of its patients? If so, how?
大体时间：Through study completion, which is expected to be a year
|
Outcome will be measured through qualitative analysis of participant answers regarding how the target condition, spasmodic dysphonia, affects the social and economic aspects of their livelihood. |
Through study completion, which is expected to be a year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
What role do botulinum toxin injections play in the socio-economic livelihood of Spasmodic Dysphonia patients?
大体时间：Through study completion, which is expected to be a year
|
Outcome will be measured through qualitative analysis of participant answers regarding how receiving Botulinum toxin injections may improve their livelihood. |
Through study completion, which is expected to be a year
|
合作者和调查者
调查人员
- 首席研究员：Sadie Khwaja, MBChB、Manchester University NHS Foundation Trust
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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
- B01796
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data will not be shared due to the sensitive nature of the study content and the interview study design
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
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