Globus PharyngeusNCT04778007
The Validation of the Turkish Version of the LUMP Questionnaire
An observational study of Globus Pharyngeus and Validation, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Globus Pharyngeus, Validation
- What is being tested?
- Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 15 Jun 2021
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who diagnosed with Globus pharyngeus
Who may be able to join
- diagnosed with globus pharyngeus in study group
- Able to speak, read, understand and write in Turkish
- give a consent form
Who cannot join
- patients with dysphagia or odynophagia
- laryngeal organic pathologies
- pharyngeal organic pathologies
- epiglottic retroversion
- malignancy
- pregnancy
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Globus Pharyngeus, Validation
- Being tested
- Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire
- Keywords
- globus, sensation, pharyngeus, laryngopharyngeal, measure, perceived, Turkish
- Medical subject headings
- Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of Laryngopharyngeal Measure of Perceived Sensation QuestionnaireOther
The Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start15 Mar 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Globus PharyngeusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Yavuz Atar, Asso.Prof,MD, Study chair, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778007
- Sponsor's protocol ID
- 90
- Status last verified
- Jul 2021
- First submitted
- 26 Feb 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31643076Korkmaz 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.
PubMed 32313894
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Laryngopharyngeal Measure of Perceived Sensation Questionnaire
- ClinicalTrials.gov ID
- NCT04778007
- Acronym / sponsor ID
- 90
- Conditions
- Globus Pharyngeus, Validation
- Keywords
- globus, sensation, pharyngeus, laryngopharyngeal, measure, perceived, Turkish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Globus pharyngeus patients | – | Other: Turkish Version of Laryngopharyngeal Measure of Perceived Sensation QuestionnaireThe 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. |
| Healty subjects | – | Other: Turkish Version of Laryngopharyngeal Measure of Perceived Sensation QuestionnaireThe second group consists of 80 healty participants will given the T-LUMP consist of 8 questions, Glasgow Edinburg Throat Scale, and Visual analog scale |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who diagnosed with Globus pharyngeus
Key inclusion criteria (3 listed)
- diagnosed with globus pharyngeus in study group
- Able to speak, read, understand and write in Turkish
- give a consent form
Key exclusion criteria (13 listed)
- patients with dysphagia or odynophagia
- laryngeal organic pathologies
- pharyngeal organic pathologies
- epiglottic retroversion
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Version of Laryngopharyngeal Measure of Perceived Sensation QuestionnaireThe Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms. | Other | Globus pharyngeus patients, Healty subjects |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Eating Assessment Tool
Time frame: Baseline
Penetration and aspiration scale
Time frame: Baseline
Yale pharyngeal residue severity rating scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 31643076Melancon 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.
- Background: PubMed 32313894Korkmaz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yavuz Atar, Asso.Prof,MD study chair
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Globus Pharyngeus and Validation, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The outcomes of the Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04778007, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.