Randomized Controlled Trial of Voice Therapy on Children with Vocal Nodules

声带小结儿童声音治疗的随机对照试验

• 批准号: 8105190
• 负责人: CHRISTOPHER J HARTNICK
• 金额: $ 69.54万
• 依托单位: MASSACHUSETTS EYE AND EAR INFIRMARY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-05 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8105190
• 关键词: 10 year old; Address; Age; Agreement; Appearance; Applications Grants; Auditory; Blinded; Child; Childhood; Clinical Trials; Consensus; Controlled Study; Data; Evaluation; Evidence based treatment; Functional disorder; Future; General Population; Goals; Inferior; Instruction; Intervention; Investments; Language; Larynx; Lesion; Measures; Modality; Nodule; Noise; Otolaryngologist; Outcome; Outcome Measure; Parents; Pathologist; Patients; Performance; Phonation; Population; Populations at Risk; Problem behavior; Protocols documentation; Proxy; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Risk; School-Age Population; Schools; Social Development; Speech; Speech Pathologist; Stimulus; Testing; Time; Voice; Voice Disorders; Voice Quality; compliance behavior; control trial; cost; demographics; design; disease characteristic; follow-up; improved; insight; instrument; pressure; primary outcome; prospective; public health relevance; randomized placebo controlled trial; response; teacher; treatment planning; vocal cord; voice therapy

DESCRIPTION (provided by applicant): Voice disorders place over five million school-aged children at increased risk for inferior school performance, dysfunctional social development, and higher participation in criminal activities. The lesions most commonly associated with pediatric vocal dysfunction are reported to be vocal fold nodules, which are present in up to 21% of the general population, and are associated with behavioral problems and inferior quality of life. Voice therapy with a speech-language pathologist is recommended by 95% of otolaryngologists for management of vocal fold nodules. This most widely used treatment for the most common lesion associated with pediatric voice disorders has not been rigorously tested in prospective controlled trials to determine whether it truly has benefits that outweigh the associated risks. A prospective clinical trial addressing whether voice therapy improve voice-related quality of life for children with apparent vocal fold nodules is a logical step toward developing an evidence-based treatment plan to optimize outcomes for this sizable population of at-risk children. There are currently no well-powered, prospective, controlled studies which compare voice therapy versus control in children who present with apparent nodules. Our goal is to remedy this deficiency through the randomized, placebo controlled study outlined in the following grant proposal. PUBLIC HEALTH RELEVANCE: Voice disorders place over five million school-aged children at increased risk for inferior school performance, dysfunctional social development, and higher participation in criminal activities. The most widely used treatment for the most common lesion associated with pediatric voice disorders has not been rigorously tested in prospective controlled trials to determine whether it truly has benefits that outweigh the associated risks. A prospective clinical trial addressing whether voice therapy improves voice-related quality of life for children with apparent vocal fold nodules is a logical step toward developing an evidence-based treatment plan to optimize outcomes for this sizable population of at-risk children.

描述（由申请人提供）：声音障碍使500多万学龄儿童面临更大的风险，包括学习成绩差、社会发展功能障碍和更高的犯罪活动参与率。据报道，与小儿声带功能障碍相关的最常见病变是声带小结，其存在于高达21%的普通人群中，并与行为问题和生活质量低下相关。95%的耳鼻喉科医生建议在语音语言病理学家的指导下对声带小结进行语音治疗。这种最广泛使用的治疗与儿科嗓音障碍相关的最常见病变的方法尚未在前瞻性对照试验中进行严格测试，以确定它是否真正具有超过相关风险的益处。 一项前瞻性临床试验旨在探讨声音治疗是否能改善明显声带小结儿童的声音相关生活质量，这是制定循证治疗计划以优化这一相当大的高危儿童人群结局的合理步骤。目前还没有充分的，前瞻性的，对照研究，比较声音治疗与控制的儿童谁提出了明显的结节。我们的目标是通过随机、安慰剂对照研究来弥补这一缺陷，该研究概述于以下拨款申请中。 公共卫生关系：声音障碍使500多万学龄儿童面临更大的风险，包括学习成绩差、社会发展功能失调以及更高程度地参与犯罪活动。与小儿嗓音障碍相关的最常见病变的最广泛使用的治疗方法尚未在前瞻性对照试验中进行严格测试，以确定其是否真正具有超过相关风险的益处。 一项前瞻性的临床试验，探讨语音治疗是否能改善明显声带小结儿童的语音相关生活质量，是制定循证治疗计划以优化这一相当大的高危儿童人群结局的合理步骤。