Investigation of the Effectiveness of Group Voice Therapy in Children

November 18, 2023 updated by: Özlem Beşik Topçu, Hacettepe University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University, Speech and Language Therapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Voice Therapy
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
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.
Active Comparator: Individual Voice Therapy
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
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.
Active Comparator: Vocal Hygiene Education
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes observed in the GRBAS score
Time Frame: Change from the baseline to tenth week
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
Time Frame: Change from the baseline to third month follow-up evaluation
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
Time Frame: Change from the baseline to sixth month follow-up evaluation
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
Time Frame: Change from the baseline to tenth week
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
Time Frame: Change from the baseline to tenth week
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
Time Frame: Change from the baseline to tenth week
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
Time Frame: Change from the baseline to third month follow-up evaluation
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
Time Frame: Change from the baseline to third month follow-up evaluation
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
Time Frame: Change from the baseline to third month follow-up evaluation
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
Time Frame: Change from the baseline to sixth month follow-up evaluation
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
Time Frame: Change from the baseline to sixth month follow-up evaluation
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
Time Frame: Change from the baseline to sixth month follow-up evaluation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 18, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUSLP_GROUPVOICETHERAPY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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