Voice FatigueNCT05999045
Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)
An observational study of Voice Fatigue, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to translate and culturally adapt the Turkish version of the EASE (EASE-TR) scale and investigate its validity and reliability. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Fatigue
- What is being tested?
- Singing activity
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2023to 1 Oct 2023
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who sings in a professional or unprofessional choir
Who may be able to join
- Having Turkish as mother tongue
- Singing in choir at least 6 months
- Performing at least for an hour
Who cannot join
- Having previously received voice therapy or undergone voice surgery
- Having a systematic/or neurological disorder that may affect voice quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Validity And Reliability of the Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)
The aim of the study is to translate and culturally adapt the Turkish version of the EASE (EASE-TR) scale and investigate its validity and reliability.
Read the detailed description
The study consists of two phases. In the first phase of the study, the scale will be translated and culturally adapted into Turkish. The second phase involves assessing participants and validating the translated scale. In this phase, participants will complete the EASE-TR and the severity part of the Vocal Tract Discomfort Scale (VTDS) before and after a 1-hour performance. One hundred choir member between the ages of 18 and 65 will be included in the study.
Both construct and criterion validity procedures will be used.Within the scope of construct validity, the "Known Groups Validity" method will be used based on variables such as experience duration, vocal training status, and the presence or absence of current vocal complaints. A comparison of pre- and post-performance EASE-TR scores will be conducted. Regarding criterion validity, the correlation between EASE scores and the severity part of the VTDS will be examined. For reliability, Cronbach's alpha and test-retest reliability will be calculated. The questionnaire will be administered a second time to 30 participants after 14 days in order to measure test-retest reliability.
- Conditions
- Voice Fatigue
- Being tested
- Singing activity
- Keywords
- Singing voice, Professional voice users
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing activityOther
The singing activity will involve a 1-hour performance, rehearsal, or lesson.
| Study group | Role | What they receive |
|---|---|---|
| choir member | a person who sings in a choir Receives: Other: Singing activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Evaluation of the Ability to Sing Easily (EASE) Turkish Version score
Turkish Version of Evaluation of the Ability to Sing Easily score: scoring ranges from 22 to 88 with higher score meaning worse outcome
Measured: 1-hour singing activity
Secondary outcomes (1)
Vocal Tract Discomfort Scale (VTDS)
The severity part of the Vocal Tract Discomfort Scale (VTDS): scoring ranges from 0 to 48 with higher score meaning worse outcome
Measured: 1-hour singing activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 Aug 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Voice FatigueStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE OGULMUS UYSAL, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999045
- Sponsor's protocol ID
- EASE-TR
- Status last verified
- Jan 2024
- First submitted
- 3 Aug 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ogulmus Uysal M, Esen Aydinli F, Incebay O, Besik Topcu O, Dasdogen U. Cross-Cultural Adaptation and Validation of the Turkish Version of the Evaluation of the Ability to Sing Easily (EASE-TR). J Voice. 2024 Nov 22:S0892-1997(24)00358-8. doi: 10.1016/j.jvoice.2024.10.016. Online ahead of print.
PubMed 39580357
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity And Reliability of the Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)
- ClinicalTrials.gov ID
- NCT05999045
- Acronym / sponsor ID
- EASE-TR
- Conditions
- Voice Fatigue
- Keywords
- Singing voice, Professional voice users
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 21 Aug 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.
The aim of the study is to translate and culturally adapt the Turkish version of the EASE (EASE-TR) scale and investigate its validity and reliability.
Detailed description
The study consists of two phases. In the first phase of the study, the scale will be translated and culturally adapted into Turkish. The second phase involves assessing participants and validating the translated scale. In this phase, participants will complete the EASE-TR and the severity part of the Vocal Tract Discomfort Scale (VTDS) before and after a 1-hour performance. One hundred choir member between the ages of 18 and 65 will be included in the study.
Both construct and criterion validity procedures will be used.Within the scope of construct validity, the "Known Groups Validity" method will be used based on variables such as experience duration, vocal training status, and the presence or absence of current vocal complaints. A comparison of pre- and post-performance EASE-TR scores will be conducted. Regarding criterion validity, the correlation between EASE scores and the severity part of the VTDS will be examined. For reliability, Cronbach's alpha and test-retest reliability will be calculated. The questionnaire will be administered a second time to 30 participants after 14 days in order to measure test-retest reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| choir member | – | Other: Singing activitya person who sings in a choir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who sings in a professional or unprofessional choir
Key inclusion criteria (3 listed)
- Having Turkish as mother tongue
- Singing in choir at least 6 months
- Performing at least for an hour
Key exclusion criteria (2 listed)
- Having previously received voice therapy or undergone voice surgery
- Having a systematic/or neurological disorder that may affect voice quality
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 |
|---|---|---|
| Singing activityThe singing activity will involve a 1-hour performance, rehearsal, or lesson. | Other | choir member |
Primary outcome
Change in Evaluation of the Ability to Sing Easily (EASE) Turkish Version score
Time frame: 1-hour singing activity
Turkish Version of Evaluation of the Ability to Sing Easily score: scoring ranges from 22 to 88 with higher score meaning worse outcome
1 secondary outcome
Vocal Tract Discomfort Scale (VTDS)
Time frame: 1-hour singing activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 39580357Ogulmus Uysal M, Esen Aydinli F, Incebay O, Besik Topcu O, Dasdogen U. Cross-Cultural Adaptation and Validation of the Turkish Version of the Evaluation of the Ability to Sing Easily (EASE-TR). J Voice. 2024 Nov 22:S0892-1997(24)00358-8. doi: 10.1016/j.jvoice.2024.10.016. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Fatigue, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 11 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Evaluation of the Ability to Sing Easily (EASE) Turkish Version score (time frame: 1-hour singing activity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05999045, which also lists 1 linked publication.
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 11 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.