Investigation of the Effectiveness of Group Voice Therapy in Children

NCT06124053 | Unknown

• 1 other identifier: HUSLP_GROUPVOICETHERAPY
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphonia

Keywords

voice therapy; group voice therapy; pediatric voice disorders; pediatric voice therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• The change observed in the Pediatric Voice Handicap Index score

  Change from the baseline to tenth week

• The change observed in the Pediatric Voice Related Quality of Life score

  Change from the baseline to tenth week

• Change in Acoustic Voice Characteristics

  Change from the baseline to tenth week

• The change observed in the Pediatric Voice Handicap Index score

  Change from the baseline to third month follow-up evaluation

• The change observed in the Pediatric Voice Related Quality of Life score

  Change from the baseline to third month follow-up evaluation

Study Arms (3)

Group Voice Therapy

EXPERIMENTAL

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

Individual Voice Therapy

ACTIVE COMPARATOR

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

Vocal Hygiene Education

ACTIVE COMPARATOR

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

Interventions

Group Voice Therapy BEHAVIORAL

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.

Group Voice Therapy

Individual Voice Therapy BEHAVIORAL

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.

Individual Voice Therapy

Vocal Hygiene Education BEHAVIORAL

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.

Vocal Hygiene Education

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Speech and Language Therapy

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatma ESEN AYDINLI, Assoc. Prof.

  Hacettepe University, Speech and Language Therapy Departmant

  STUDY CHAIR

• Meltem Çiğdem KİRAZLI, Ph.D.

  Hacettepe University, Speech and Language Therapy Departmant

  STUDY CHAIR

• Taner Yılmaz, Prof.

  Hacettepe University, Department of Otorhinolaryngology

  STUDY CHAIR

Central Study Contacts

Özlem BEŞİK TOPÇU, SLP

CONTACT

(+90)5385032233; ozlembesik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be grouped based on the Grade scores on the GRBAS scale using a stratified sampling method.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 9, 2023
• Study Start: November 15, 2023
• Primary Completion: November 30, 2024
• Study Completion: June 30, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)