The Validation of the Turkish Version of the LUMP Questionnaire

Validation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778007
• Other study ID #: 90
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: July 2021
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Globus Pharyngeus
• Validation

Intervention

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.

Locations

Country	Name	City	State
Turkey	Yavuz Atar	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Korkmaz MÖ, Tüzüner A, Bahçecitapar 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject demographics	The median values of age and ratio of gender, and education with profession profile in all groups	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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