An interventional study of Group Voice Therapy and Individual Voice Therapy in Dysphonia, sponsored by Hacettepe University. Recruiting at 1 site in Turkey. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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.
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.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 18 is below the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
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
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
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
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.
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.
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.
Changes observed in the GRBAS score
The changes observed in the GRBAS parameters between pre-intervention and post-intervention evaluations.
Time frame: 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.
Time frame: 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.
Time frame: Change from the baseline to sixth 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from the baseline to sixth month follow-up evaluation
Plan to share: No
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