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: 8685003
• 负责人: CHRISTOPHER J HARTNICK
• 金额: $ 67.52万
• 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 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8685003
• 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; 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.

描述（由申请人提供）：嗓音障碍使超过 500 万学龄儿童面临更高的学习成绩差、社会发展功能失调以及更多参与犯罪活动的风险。据报道，与儿童声带功能障碍最常见的病变是声带小结，其存在于高达 21% 的普通人群中，并且与行为问题和生活质量差有关。 95% 的耳鼻喉科医生建议由言语病理学家进行声音治疗来治疗声带小结。这种最广泛使用的治疗与儿科声音障碍相关的最常见病变的方法尚未经过前瞻性对照试验的严格测试，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可以改善患有明显声带小结的儿童与声音相关的生活质量，这是制定循证治疗计划以优化这一大量高危儿童的治疗结果的合理步骤。目前还没有强有力的、前瞻性的、对照研究来比较声音治疗与对照组对有明显结节的儿童的治疗效果。我们的目标是通过以下拨款提案中概述的随机、安慰剂对照研究来弥补这一缺陷。