Clinical trial NCT04778007: The Validation of the Turkish Version of the LUMP Questionnaire
Official title: Validity and Reliability of the Turkish Version of the Laryngopharyngeal Measure of Perceived Sensation Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Globus Pharyngeus
Validation
Keywords: globus
sensation
pharyngeus
laryngopharyngeal
measure
perceived
Turkish
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who diagnosed with Globus pharyngeus

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.

Eligibility criteria: 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

Primary outcomes:
measure: The outcomes of the Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire
timeFrame: Baseline
measure: The outcomes of the Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire
timeFrame: 2 weeks
measure: The outcomes of Glasgow Edinburg Throat Scale
timeFrame: Baseline
measure: The outcomes of the visual analog scale
timeFrame: Baseline
measure: The outcomes of the visual analog scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Eating Assessment Tool
timeFrame: Baseline
measure: Penetration and aspiration scale
timeFrame: Baseline
measure: Yale pharyngeal residue severity rating scale
timeFrame: Baseline
Other outcomes:
measure: Subject demographics
timeFrame: Baseline
Locations:
city: Istanbul
country: Turkey
facility: Yavuz Atar
Study officials:
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
name: Yavuz Atar, Asso.Prof,MD
role: STUDY_CHAIR
References:
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.
citation: 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.