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临床试验/NCT06030583
NCT06030583已完成不适用

An Investigation of Vocal Hygiene, Vocal Behaviors, and Quality of Life Associated With Voice in Children With and Without Attention Deficit Hyperactivity Disorder

Hacettepe University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Inter-group Differences Associated with Vocal Hygiene Knowledge

研究概览

简要总结

The aim is to gain information about vocal hygiene knowledge level, phonotrauma behavior frequency, voice-related quality of life, and voice handicap index scores in children diagnosed with ADHD aged 8 to 11, through inter-group comparisons of scale and questionnaire data between children diagnosed with ADHD and control group participants aged 8 to 11.

详细描述

The study will include children aged 8 to 11 with and without a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). The study and control groups have been determined with age and gender matching.

Within the scope of the study, a comparison between groups will be conducted through the scores of the Vocal Hygiene Awareness form, Pediatric Phonotrauma Assessment Questions for Parents, Voice Related Quality of Life Survey, and the Teacher-Reported Pediatric Voice Handicap Index to examine whether there are any differences between the groups. The Vocal Hygiene Awareness form will be completed by the child. The Pediatric Phonotrauma Assessment Questions for Parents, Voice Related Quality of Life Survey, and the Pediatric Voice Handicap Index will be completed by the parents. The Teacher-Reported Pediatric Voice Handicap Index will be filled out by the child's teacher.

The number of participants to be included in the study has been calculated using G Power 3.1 program. Based on an analysis with a power of 0.80 and α (type 1 error) = 0.05 using an independent t-test, 42 participants for each group, totaling 84 participants, are planned to be included in the study. Data analysis will be carried out using IBM SPSS Statistics 23 program. Firstly, the normal distribution of ordinal variables will be tested. If the assumption of normality is met, parametric tests will be used; otherwise, non-parametric tests will be employed. A statistical significance value of p < 0.05 will be considered.

研究设计

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

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For study group
  • Having been diagnosed with ADHD according to DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnostic criteria
  • Being in the age range of 8-11
  • Having Turkish as the native language
  • To have a score below the cut-off score (<13) on the Turkish Pediatric Voice Handicap Index.
  • For the control group:
  • Not having any psychiatric diagnosis
  • Being in the age range of 8-11
  • Having Turkish as the native language
  • To have a score below the cut-off score (<13) on the Turkish Pediatric Voice Handicap Index.

排除标准

  • For the research group;
  • Having any history of upper respiratory tract infection in the period up to two weeks before the data collection date (one of the questionnaire requests considering the last two-week period as a reference).
  • Having any known neurological, systemic, or endocrinological diseases affecting the voice.
  • Having undergone vocal surgery or received voice therapy.
  • Having a diagnosis of current hearing loss.
  • Having comorbid autism spectrum disorder, intellectual disability, language, and speech disorders.
  • The family or the child not wanting to participate in the study.
  • For the control group;
  • Having any history of upper respiratory tract infection in the period up to two weeks before the data collection date.
  • Having any known neurological, systemic, or endocrinological diseases affecting the voice.
  • Having undergone vocal surgery or received voice therapy.
  • Having a diagnosis of current hearing loss.
  • Having a neurological or psychiatric diagnosis.
  • Having a diagnosis of language and speech disorders.
  • The family or the child not wanting to participate in the study.

结局指标

主要结局

Inter-group Differences Associated with Vocal Hygiene Knowledge

时间窗: The process of collecting data from participants once takes approximately 30 minutes

Scores Obtained from Questions on Vocal Hygiene Awareness

Inter-group Differences Associated with Phonotraumatic Behaviors

时间窗: The process of collecting data from participants once takes approximately 30 minutes

Scores Obtained from Pediatric Phonotrauma Assessment Questions for Parents

次要结局

  • Inter-group Differences Associated with Voice Related Quality of Life Survey(The process of collecting data from participants once takes approximately 30 minutes)
  • Inter-group Differences Associated with the Teacher-Reported Pediatric Voice Handicap Index(The process of collecting data from participants once takes approximately 30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Beşik Topçu

Principal Investigator

Hacettepe University

研究点 (1)

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