Clinical trial NCT06124053: Investigation of the Effectiveness of Group Voice Therapy in Children
Official title: Comparing Outcomes of Group Voice Therapy and Individual Voice Therapy in Children With Dysphonia Between the Ages of 7-11
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphonia
Keywords: voice therapy
group voice therapy
pediatric voice disorders
pediatric voice therapy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 18
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be grouped based on the Grade scores on the GRBAS scale using a stratified sampling method.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes observed in the GRBAS score
timeFrame: Change from the baseline to tenth week
measure: Changes observed in the GRBAS score
timeFrame: Change from the baseline to third month follow-up evaluation
measure: Changes observed in the GRBAS score
timeFrame: Change from the baseline to sixth month follow-up evaluation
Secondary outcomes:
measure: The change observed in the Pediatric Voice Handicap Index score
timeFrame: Change from the baseline to tenth week
measure: The change observed in the Pediatric Voice Related Quality of Life score
timeFrame: Change from the baseline to tenth week
measure: Change in Acoustic Voice Characteristics
timeFrame: Change from the baseline to tenth week
measure: The change observed in the Pediatric Voice Handicap Index score
timeFrame: Change from the baseline to third month follow-up evaluation
measure: The change observed in the Pediatric Voice Related Quality of Life score
timeFrame: Change from the baseline to third month follow-up evaluation
measure: Change in Acoustic Voice Characteristics
timeFrame: Change from the baseline to third month follow-up evaluation
measure: The change observed in the Pediatric Voice Handicap Index score
timeFrame: Change from the baseline to sixth month follow-up evaluation
measure: The change observed in the Pediatric Voice Related Quality of Life score
timeFrame: Change from the baseline to sixth month follow-up evaluation
measure: Change in Acoustic Voice Characteristics
timeFrame: Change from the baseline to sixth month follow-up evaluation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Speech and Language Therapy
Study officials:
affiliation: Hacettepe University, Speech and Language Therapy Departmant
name: Fatma ESEN AYDINLI, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University, Speech and Language Therapy Departmant
name: Meltem Çiğdem KİRAZLI, Ph.D.
role: STUDY_CHAIR
affiliation: Hacettepe University, Department of Otorhinolaryngology
name: Taner Yılmaz, Prof.
role: STUDY_CHAIR
References: