The Validation of the Turkish Version of the LUMP Questionnaire

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

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.

Study Overview

• Status: Completed
• Conditions: Globus Pharyngeus; Validation
• Intervention / Treatment: Other: Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire

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 Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34384
    • Yavuz Atar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients who diagnosed with Globus pharyngeus

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Globus pharyngeus patients; 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; The Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms.
Healty subjects; 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; The Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject demographics	The median values of age and ratio of gender, and education with profession profile in all groups	Baseline

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• Investigators: Study Chair: Yavuz Atar, Asso.Prof,MD, Prof. Dr. Cemil Taşçıoğlu City Hospital

Publications and helpful links

General Publications

• Melancon CC, Russell GB, Ruckart K, Persia S, Peterson M, Carter Wright S Jr,, Madden LL. The development and validation of the laryngopharyngeal measure of perceived sensation. Laryngoscope. 2020 Dec;130(12):2767-2772. doi: 10.1002/lary.28348. Epub 2019 Oct 23.
• Korkmaz MO, Tuzuner A, Bahcecitapar M, Karacaer C. Reliability and Validity of the Turkish Version of the Glasgow-Edinburgh Throat Scale: Use for a Symptom Scale of Globus Sensation in Turkish Population. Turk Arch Otorhinolaryngol. 2020 Mar;58(1):41-47. doi: 10.5152/tao.2020.4686. Epub 2019 Aug 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2021
• Primary Completion (ACTUAL): June 15, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (ACTUAL): March 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: sensation; globus; Turkish; pharyngeus; laryngopharyngeal; measure; perceived
• Additional Relevant MeSH Terms: Mental Disorders; Conversion Disorder; Somatoform Disorders; Globus Sensation
• Other Study ID Numbers: 90

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