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临床试验/NCT04563884
NCT04563884已完成不适用

Validity of the French Version of Deafness Questionnaires for Children and Adolescents

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2020年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Paired student t-test

研究概览

简要总结

The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.

Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.

Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.

The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group.

The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.

详细描述

Neonatal sensorineural hearing loss is a frequent pathology, affecting around 800 newborns per year in France, or an incidence of 0.8 to 1.3 per 1000 births, comparable to other industrialized countries. It can affect the development of speech and language and lead to impaired quality of life.

Studies have shown that children with hearing loss score lower on general quality-of-life measurement tools, compared to their normal-hearing peers. A poorer quality of life in patients with sensorineural hearing loss may also reflect physical, academic, social or emotional difficulties. They are also exposed to an increased risk of poor development of language and social skills, as well as an increased risk of developing psychiatric pathologies.

The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.

Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.

Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Months 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Minors aged 12 months to 17 years (inclusive)
  • •Patients followed in consultation at Necker Hospital in the Pediatric ENT department
  • •holders of parental authority not opposed to participation in the study
  • •Patients with deafness with mean tonal thresholds of at least 30dB, uni- or bilateral
  • •Perceptual or transmission deafness or mixed
  • •Patients not presenting a hearing disorder at the time of inclusion or in his or her history
  • •Examination of the normal eardrums
  • •No history of ear surgery

排除标准

  • •Psychomotor retardation
  • •Abnormal neurological examination
  • •Mother tongue of the child and parents other than French

研究组 & 干预措施

Patients with deafness

Patients aged 12 months to 17 years with deafness

干预措施: Questionnaires (Other)

Controls

Normal-hearing patients aged 12 months to 17 years

干预措施: Questionnaires (Other)

结局指标

主要结局

Paired student t-test

时间窗: 1 year

Reproducibility of the questionnaire completed by a subject at 15 days apart

Cronbach alpha test

时间窗: 1 year

Internal consistency

Item-total Pearson correlation

时间窗: 1 year

Measure of reliability

Principal components analysis

时间窗: 1 year

Measure of efficiency

Receiver Operating Characteristic (ROC) curve

时间窗: 1 year

Limit value of normality

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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