The Validation of the Turkish Version of the LUMP Questionnaire

Completed

• Conditions: Globus Pharyngeus; Validation
• Interventions: Other: Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire

• Registration Number: NCT04778007
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-02
• Study Start: 2021-03-15
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Globus pharyngeus patients	Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire	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.
Healty subjects	Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire	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

Primary Outcome Measures

Name	Time	Method
The outcomes of Glasgow Edinburg Throat Scale	Baseline	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.
The outcomes of the Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire	2 weeks	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.
The outcomes of the visual analog scale	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Eating Assessment Tool	Baseline	The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.
Penetration and aspiration scale	Baseline	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.
Yale pharyngeal residue severity rating scale	Baseline	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.

Trial Locations

Locations (1)

Yavuz Atar; 🇹🇷 Istanbul, Turkey