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Completed

NCT Number: NCT04778007

The Validation of the Turkish Version of the LUMP 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.

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Key information

Conditions

Globus Pharyngeus Conversion Disorder Globus Sensation Mental Disorders Somatoform Disorders Validation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yavuz Atar

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The outcomes of the Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire

    Time frame: Baseline

    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.

  2. The outcomes of the Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire

    Time frame: 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.

  3. The outcomes of Glasgow Edinburg Throat Scale

    Time frame: 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.

  4. The outcomes of the visual analog scale

    Time frame: Baseline

    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.

  5. The outcomes of the visual analog scale

    Time frame: 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 outcomes

  1. Eating Assessment Tool

    Time frame: Baseline

    The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.

  2. Penetration and aspiration scale

    Time frame: 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.

  3. Yale pharyngeal residue severity rating scale

    Time frame: 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.

Other outcomes

  1. Subject demographics

    Time frame: Baseline

    The median values of age and ratio of gender, and education with profession profile in all groups

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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