Validation of the Turkish Translation of the London Speech Evaluation Scale

Validation and Cultural Adaptation of the Turkish Translation of the London Speech Evaluation Scale

Purpose of the study is the validation and cultual adaptation of the Turkish translation of the London Speech Evaluation Scale (LSE-T), so that it would be used as an assessment tool for Turkish head and neck cancer patients. There is no validated Turkish version of LSE to measure severity of perceptual speech in head and neck cancer patients.

Study Overview

Detailed Description

The speech function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as voice analysis computer programmes, scales, or well structured questionnaires. There are many scales for assessment of perceptual speech but there is no validated for head and neck patients. The study will assess the construct validity and adaptation of the Turkish translation of Speech Specific Perceptual Speech Evaluation as known as London Speech Evaluation Scale. The investigators developed the Turkish translation of this scale (LSE-T), according to the cross-cultural adaptation guidelines. Two translators translated the LSE into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The LSE scale consisted of 6 parameters and 4 scores related with perceptual speech in head and neck cancer patients.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34384
        • Prof Dr Cemil Tascioglu City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with oral, oropharyngeal cancer and healthy adults

Description

Inclusion Criteria:

  • Able to speak, read, understand and write in Turkish
  • History of oral, orofarengeal cancer
  • Volunteers who accept the informed consent

Exclusion Criteria:

  • Mental disorders
  • Cognitive limitations
  • Able not to speak, read, understand and write in Turkish
  • Underwent any surgery last six month
  • Permanent tracheostomy, total laryngectomy
  • Pregnancy
  • Out of age 18-70 years old
  • Adults who do not accept the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer Patients
In outpatients clinic, the first group consists of 60 head and neck cancer patients who were treated by ours. The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin. The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist). Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters. After the six weeks, the records were scored again as randomisely.
The document consists "bit, bet, but" words and Diyet passage. Volunteers will read the document in front of the microphone and also the speech will recorded by a computer.
Healty Control
In outpatients clinic, the control group consists of 60 patients who have not speech and hear impairments. The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin. The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist). Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters. After the six weeks, the records were scored again as randomisely.
The document consists "bit, bet, but" words and Diyet passage. Volunteers will read the document in front of the microphone and also the speech will recorded by a computer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the Turkish Translation of London Speech Evaluation Scale
Time Frame: Baseline
Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores.
Baseline
Validation of the Turkish Translation of London Speech Evaluation Scale
Time Frame: 6 weeks
Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ziya Salturk, Asso Prof,MD, Anadolu Medical Center, In Affiliation with Johns Hopkins Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2020

Primary Completion (ACTUAL)

May 21, 2021

Study Completion (ACTUAL)

May 21, 2021

Study Registration Dates

First Submitted

December 26, 2020

First Submitted That Met QC Criteria

December 26, 2020

First Posted (ACTUAL)

December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

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