The Validation of the Turkish Version of the LUMP Questionnaire

NCT04778007 | Completed

• 1 other identifier: 90
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Globus Pharyngeus; Validation

Keywords

globus; sensation; pharyngeus; laryngopharyngeal; measure; perceived; Turkish

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Eating Assessment Tool

  Baseline

• Penetration and aspiration scale

  Baseline

• Yale pharyngeal residue severity rating scale

  Baseline

Other Outcomes (1)

• Subject demographics

  Baseline

Study Arms (2)

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

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

Interventions

Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire OTHER

The Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms.

Globus pharyngeus patients; Healty subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients who diagnosed with Globus pharyngeus

You may qualify if:

• diagnosed with globus pharyngeus in study group
• Able to speak, read, understand and write in Turkish
• give a consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Yavuz Atar

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 31643076 BACKGROUND

• 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.

  PMID: 32313894 BACKGROUND

MeSH Terms

Conditions

Globus Sensation

Condition Hierarchy (Ancestors)

Conversion Disorder; Somatoform Disorders; Mental Disorders

Study Officials

• Yavuz Atar, Asso.Prof,MD

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., M.D.

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: March 15, 2021
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)