The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05999045
Recruitment Status : Completed
First Posted : August 21, 2023
Last Update Posted : January 11, 2024
Sponsor:
Information provided by (Responsible Party):
MERVE OGULMUS UYSAL, Hacettepe University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Voice Fatigue Other: Singing activity

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Investigation of the Validity And Reliability of the Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)
Actual Study Start Date : August 10, 2023
Actual Primary Completion Date : October 1, 2023
Actual Study Completion Date : October 1, 2023
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
choir member
a person who sings in a choir
 Other: Singing activity
The singing activity will involve a 1-hour performance, rehearsal, or lesson.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Vocal Tract Discomfort Scale (VTDS) [ Time Frame: 1-hour singing activity ]
    The severity part of the Vocal Tract Discomfort Scale (VTDS): scoring ranges from 0 to 48 with higher score meaning worse outcome


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who sings in a professional or unprofessional choir
Criteria

Inclusion Criteria:

  • Having Turkish as mother tongue
  • Singing in choir at least 6 months
  • Performing at least for an hour

Exclusion Criteria:

  • Having previously received voice therapy or undergone voice surgery
  • Having a systematic/or neurological disorder that may affect voice quality
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05999045


Locations
Layout table for location information
Turkey
Hacettepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: MERVE OGULMUS UYSAL, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT05999045    
Other Study ID Numbers: EASE-TR
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: January 11, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MERVE OGULMUS UYSAL, Hacettepe University:
Singing voice
Professional voice users
Additional relevant MeSH terms:
Layout table for MeSH terms
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases