Investigation of the Effectiveness of Group Voice Therapy in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dysphonia

Intervention / Treatment
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* Behavioral: Group Voice Therapy
* Behavioral: Individual Voice Therapy
* Behavioral: Vocal Hygiene Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 7-11. Having Turkish as the native language. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be grouped based on the Grade scores on the GRBAS scale using a stratified sampling method.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Voice Therapy<br>In this research, a total of eight sessions of group voice therapy will be applied as the intervention approach. It is planned that each group will consist of three participants. Participants will be evaluated before the intervention, after the intervention, at the third-month follow-up assessment, and at the sixth-month follow-up assessment. Both formal and informal assessment tools have been preferred for the evaluation. Researchers will collect case histories and demographic information. For the acoustic assessment of the participants, voice recordings will be obtained through the ComputerizedSpeech Lab (CLS) program. GRBAS scores will be conducted by the researchers, while Pediatric Voice Handicap Index (pVHI) and Pediatric Voice Related Quality of Life (pVRQOL) scales will be filled out by parents. | Behavioral: Group Voice Therapy<br>* The group voice therapy intervention consists of a total of eight sessions. The session contents include both direct and indirect voice therapy approaches. Each group is composed of three participants. The session durations are planned to be 45-60 minutes each.<br>|
| Active Comparator: Individual Voice Therapy<br>In this research, a total of eight sessions of individual voice therapy will be implemented as the intervention approach. Participants will be evaluated before the intervention, after the intervention, at the third-month follow-up assessment, and at the sixth-month follow-up assessment. Both formal and informal assessment tools have been chosen for the evaluation. Researchers will collect case histories and demographic information. For the acoustic assessment of the participants, voice recordings will be obtained through the CLS program. GRBAS scores will be conducted by the researchers, while pVHI and pVRQOL scales will be filled out by parents or guardians. | Behavioral: Individual Voice Therapy<br>* The individual voice therapy intervention consists of a total of eight sessions. The session contents include both direct and indirect voice therapy approaches. The session durations are planned to be 45-60 minutes each.<br>|
| Active Comparator: Vocal Hygiene Education<br>Participants will receive a one-session vocal hygiene training. Participants will be evaluated twice: once before the vocal hygiene training and again 8 weeks after the vocal hygiene training. Both formal and informal assessment tools have been preferred for the evaluation. Researchers will collect case histories and demographic information. For the acoustic assessment of the participants, voice recordings will be obtained through the CLS program. GRBAS scores will be conducted by the researchers, while pVHI and pVRQOL scales will be filled out by parents. | Behavioral: Vocal Hygiene Education<br>* Regarding vocal hygiene training, information related to voice production and respiratory characteristics will be provided, and guidance on correct and incorrect voice use will be given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes observed in the GRBAS score | The changes observed in the GRBAS parameters between pre-intervention and post-intervention evaluations. | Change from the baseline to tenth week | 
| Changes observed in the GRBAS score | The changes observed in the GRBAS parameters between pre-intervention and post-intervention evaluations. | Change from the baseline to third month follow-up evaluation | 
| Changes observed in the GRBAS score | The changes observed in the GRBAS parameters between pre-intervention and post-intervention evaluations. | Change from the baseline to sixth month follow-up evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change observed in the Pediatric Voice Handicap Index score | The changes observed in the Pediatric Voice Handicap Index total score and subscale scores between pre-intervention and post-intervention evaluations. | Change from the baseline to tenth week | 
| The change observed in the Pediatric Voice Related Quality of Life score | The changes observed in the Pediatric Voice Quality of Life score and scores between pre-intervention and post-intervention evaluations. | Change from the baseline to tenth week | 
| Change in Acoustic Voice Characteristics | The changes observed in the F0, Jitter, Shimmer, and Noise to Harmonic Ratio values for the sustain /a/ phonation recording obtained through the Multi-Dimensional Voice Program (MDVP) by Kaypentax Computerized Speech Lab between pre-therapy and post-therapy evaluations. | Change from the baseline to tenth week | 
| The change observed in the Pediatric Voice Handicap Index score | The changes observed in the Pediatric Voice Handicap Index total score and subscale scores between pre-intervention and post-intervention evaluations. | Change from the baseline to third month follow-up evaluation | 
| The change observed in the Pediatric Voice Related Quality of Life score | The changes observed in the Pediatric Voice Quality of Life score and scores between pre-intervention and post-intervention evaluations. | Change from the baseline to third month follow-up evaluation | 
| Change in Acoustic Voice Characteristics | The changes observed in the F0, Jitter, Shimmer, and Noise to Harmonic Ratio values for the sustain /a/ phonation recording obtained through the Multi-Dimensional Voice Program (MDVP) by Kaypentax Computerized Speech Lab between pre-therapy and post-therapy evaluations. | Change from the baseline to third month follow-up evaluation | 
| The change observed in the Pediatric Voice Handicap Index score | The changes observed in the Pediatric Voice Handicap Index total score and subscale scores between pre-intervention and post-intervention evaluations. | Change from the baseline to sixth month follow-up evaluation | 
| The change observed in the Pediatric Voice Related Quality of Life score | The changes observed in the Pediatric Voice Quality of Life score and scores between pre-intervention and post-intervention evaluations. | Change from the baseline to sixth month follow-up evaluation | 
| Change in Acoustic Voice Characteristics | The changes observed in the F0, Jitter, Shimmer, and Noise to Harmonic Ratio values for the sustain /a/ phonation recording obtained through the Multi-Dimensional Voice Program (MDVP) by Kaypentax Computerized Speech Lab between pre-therapy and post-therapy evaluations. | Change from the baseline to sixth month follow-up evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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voice therapy, group voice therapy, pediatric voice disorders, pediatric voice therapy