Investigation of the Effectiveness of Group Voice Therapy in Children

Dysphonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124053
• Other study ID #: HUSLP_GROUPVOICETHERAPY
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Hacettepe University
• Contact: Özlem BESIK TOPÇU, SLP
• Phone: (+90)5385032233
• Email: ozlembesik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Speech and Language Therapy	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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