DysphoniaNCT06124053
Investigation of the Effectiveness of Group Voice Therapy in Children
A study testing Group Voice Therapy, Individual Voice Therapy and Vocal Hygiene Education in people with Dysphonia, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Dysphonia
- What is being tested?
- Group Voice Therapy, Individual Voice Therapy and Vocal Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University, Speech and Language Therapy
Ankara
Özlem Beşik Topçu, SLP, (+90)5385032233, ozlembesik@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysphonia
- Being tested
- Group Voice Therapy, Individual Voice Therapy, Vocal Hygiene Education
- Keywords
- voice therapy, group voice therapy, pediatric voice disorders, pediatric voice therapy
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Voice TherapyBehavioural
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 TherapyBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Vocal Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes observed in the GRBAS score
The changes observed in the GRBAS parameters between pre-intervention and post-intervention evaluations.
Measured: 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.
Measured: 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.
Measured: Change from the baseline to sixth month follow-up evaluation
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from the baseline to sixth month follow-up evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start15 Nov 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be grouped based on the Grade scores on the GRBAS scale using a stratified sampling method.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Beşik Topçu, Hacettepe University
- Investigators
- Fatma ESEN AYDINLI, Assoc. Prof., Study chair, Hacettepe University, Speech and Language Therapy DepartmantMeltem Çiğdem KİRAZLI, Ph.D., Study chair, Hacettepe University, Speech and Language Therapy DepartmantTaner Yılmaz, Prof., Study chair, Hacettepe University, Department of Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124053
- Sponsor's protocol ID
- HUSLP_GROUPVOICETHERAPY
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Outcomes of Group Voice Therapy and Individual Voice Therapy in Children With Dysphonia Between the Ages of 7-11
- ClinicalTrials.gov ID
- NCT06124053
- Acronym / sponsor ID
- HUSLP_GROUPVOICETHERAPY
- Conditions
- Dysphonia
- Keywords
- voice therapy, group voice therapy, pediatric voice disorders, pediatric voice therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be grouped based on the Grade scores on the GRBAS scale using a stratified sampling method.
| Arm | Type | Receives |
|---|---|---|
| Group Voice Therapy | Experimental | Behavioral: Group Voice TherapyIn 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. |
| Individual Voice Therapy | Active comparator | Behavioral: Individual Voice TherapyIn 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. |
| Vocal Hygiene Education | Active comparator | Behavioral: Vocal Hygiene EducationParticipants 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Voice TherapyThe "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. | Behavioural | Group Voice Therapy |
| Individual Voice TherapyThe "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. | Behavioural | Individual Voice Therapy |
| Vocal Hygiene EducationRegarding 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. | Behavioural | Vocal Hygiene Education |
Primary outcome
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.
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.
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.
9 secondary outcomes
The change observed in the Pediatric Voice Handicap Index score
Time frame: 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
Change in Acoustic Voice Characteristics
Time frame: 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 change observed in the Pediatric Voice Related Quality of Life score
Time frame: 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 change observed in the Pediatric Voice Handicap Index score
Time frame: 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
Change in Acoustic Voice Characteristics
Time frame: Change from the baseline to sixth month follow-up evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma ESEN AYDINLI, Assoc. Prof. study chair
Hacettepe University, Speech and Language Therapy Departmant
Meltem Çiğdem KİRAZLI, Ph.D. study chair
Hacettepe University, Speech and Language Therapy Departmant
Taner Yılmaz, Prof. study chair
Hacettepe University, Department of Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Voice Therapy, Individual Voice Therapy and Vocal Hygiene Education in people with Dysphonia, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özlem BEŞİK TOPÇU, SLP ((+90)5385032233, ozlembesik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes observed in the GRBAS score (time frame: Change from the baseline to tenth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.