跳至主要内容
临床试验/NCT06124053
NCT06124053招募中不适用

Comparing Outcomes of Group Voice Therapy and Individual Voice Therapy in Children With Dysphonia Between the Ages of 7-11

Hacettepe University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
1
主要终点
Changes observed in the GRBAS score

研究概览

简要总结

This study aims to investigate whether there is a difference between groups receiving "group voice therapy" and "individual voice therapy" in pediatric populations diagnosed with dysphonia. In this context, the goal is to comprehensively examine the effectiveness of "group voice therapy" in pediatric populations compared to similar studies in the literature. In line with this objective, it is aimed to comprehensively test its effectiveness by including perceptual and acoustic evaluation findings, objective and subjective assessments, and incorporating comparison and control groups into the study, as compared to similar studies in the literature.

详细描述

There are three groups in total in the study: two research groups and one control group. The first research group will receive "group voice therapy". Group voice therapy sessions are arranged in groups of three. A total of eight sessions will be given, one session per week. The second research group will receive "individual voice therapy". In this context, participants will be given individual voice therapy for a total of eight sessions, one session per week. The voice therapy approach to be applied to participants receiving individual voice therapy and group voice therapy includes direct and indirect voice therapy methods.Control group participants will receive a one-session "vocal hygiene training".

Control group participants will be evaluated before and after vocal hygiene training. The first and second research groups will be evaluated four times in total: before therapy, after therapy, third month follow-up and sixth month follow-up. It is aimed to examine the effectiveness of "group voice therapy" by comparing the findings obtained from the approaches. Objective and subjective evaluation tools will be used in the evaluations. It is expected that Research Group 1, receiving "group voice therapy," and Research Group 2, receiving "individual voice therapy," will demonstrate a significant decrease in the primary outcome measure, the GRBAS score, and secondary outcome measures, including the Pediatric Voice Handicap Index score, the Teacher's Perception-Based Voice Handicap Index score, and a significant increase in the Pediatric Voice-Related Quality of Life Scale score when comparing pre-therapy and post-therapy assessments. It is anticipated that these significant changes will be sustained in the follow-up evaluations.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The allocation of participants to groups will be carried out through stratified sampling based on the Grade parameter of the GRBAS scoring. Accordingly, individuals conducting GRBAS scoring will listen to the recordings of participants in an anonymous manner.

入排标准

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

入选标准

  • Having been diagnosed with vocal fold lesions.
  • Being referred to Hacettepe University Speech and Language Therapy Department for a diagnosis of voice disorder by Hacettepe University Ear, Nose, and Throat Department.
  • Being in the age range of 7-
  • Having Turkish as the native language.

排除标准

  • Having a history of any upper respiratory tract infection up to two weeks before the date of data collection (it is requested to consider the last two weeks as a reference in one of the questionnaires to be filled out).
  • Having any known neurological, systemic, or endocrinological disease that affects one's voice.
  • Having undergone any surgical intervention related to the voice or received voice therapy before the research process.
  • Having a diagnosis of current hearing loss.
  • Having a neurological or psychiatric diagnosis.
  • The family or child not wanting to participate in the study.
  • Not having acquired reading and writing skills yet

结局指标

主要结局

Changes observed in the GRBAS score

时间窗: Change from the baseline to sixth month follow-up evaluation

The changes observed in the GRBAS parameters between pre-intervention and post-intervention evaluations.

次要结局

  • The change observed in the Pediatric Voice Related Quality of Life score(Change from the baseline to sixth month follow-up evaluation)
  • Change in Acoustic Voice Characteristics(Change from the baseline to sixth month follow-up evaluation)
  • The change observed in the Pediatric Voice Handicap Index score(Change from the baseline to sixth month follow-up evaluation)

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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