The Validation of the Turkish Version of the LUMP Questionnaire

Study Overview
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Brief Summary
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Purpose of the study is the validity and reliability of the Turkish version of the Laryngopharyngeal Measure of Perceived Sensation (T-LUMP) Questionnaire, so that it would be used as an assessment tool for Turkish globus pharyngeus patients.

Detailed Description
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Globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. The study will assess the construct validity and reliability of the Turkish version of Laryngopharyngeal Measure of Perceived Sensation (T-LUMP) Questionnaire. The investigators developed the Turkish version of this questionnaire (T-LUMP), according to the cross-cultural adaptation guidelines. Two translators translated the LUMP 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 final version of the LUMP questionnaire consisted of 8 basic and understandable questions related with globus pharyngeus symptoms.

Official Title
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Validity and Reliability of the Turkish Version of the Laryngopharyngeal Measure of Perceived Sensation Questionnaire

Conditions
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Globus Pharyngeus, Validation

Intervention / Treatment
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* Other: Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with globus pharyngeus in study group Able to speak, read, understand and write in Turkish give a consent form Exclusion Criteria: patients with dysphagia or odynophagia laryngeal organic pathologies pharyngeal organic pathologies epiglottic retroversion malignancy pregnancy mental disorders neurological disorders major psychiatric disorders Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy Underwent any surgery last a year Cognitive limitations give not a consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Globus pharyngeus patients<br>The first group consists of 80 globus pharyngeus patients who have at least a year of globus sensation complaints. The participants will given the Turkish Version of the Laryngopharyngeal Measure of Perceived Sensation Questionnaire (T-LUMP), consist of 8 questions, Glasgow Edinburg Throat Scale, and Visual analog scale. After the two weeks, 80 participants will given the T-LUMP and Visual analog scale for sampling. | Other: Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire<br>* The Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms.<br>|
| Healty subjects<br>The second group consists of 80 healty participants will given the T-LUMP consist of 8 questions, Glasgow Edinburg Throat Scale, and Visual analog scale | Other: Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire<br>* The Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcomes of the Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire | Turkish version of the questionnaire consists of 8 questions about globus pharyngeus consequences during patients at least a year and healty subjects. The minimum score is 0 and maximum score is 32. The lower scores mean no problem, higher scores mean significant problem. | Baseline | 
| The outcomes of the Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire | Turkish version of the questionnaire consists of 8 questions about globus pharyngeus consequences during patients at least a year. The minimum score is 0 and maximum score is 32. The lower scores mean no problem, higher scores mean significant problem. | 2 weeks | 
| The outcomes of Glasgow Edinburg Throat Scale | It was assessed by Turkish validated Glasgow Edinburg Throat Scale that a self questionnaire in globus pharyngeus patients. The minimum score is 0 and maximum score is 7 per question. The high scores were worst low scores were good. | Baseline | 
| The outcomes of the visual analog scale | The globus sense was assessed by visual analog scale. The minimum score is 0 and maximum score is 100 on a line as 100 millimetres . The high scores were worst low scores were good. | Baseline | 
| The outcomes of the visual analog scale | The globus sense was assessed by visual analog scale. The minimum score is 0 and maximum score is 100 on a line as 100 millimetres . The high scores were worst low scores were good. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Assessment Tool | The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse. | Baseline | 
| Penetration and aspiration scale | The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse. | Baseline | 
| Yale pharyngeal residue severity rating scale | The scale consists of 5 assessment units for pharyngeal residue. The scores are from 1 to 5. Low score is better, higher score is worse. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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globus, sensation, pharyngeus, laryngopharyngeal, measure, perceived, Turkish