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NCT Number: NCT05296655

Kazakh Version of Reflux Symptom Index

Reflux symptoms index (RSI) were developed to identify a clinical index of suspicion for laryngopharyngeal reflux (LPR) in patients with ear, nose, and throat symptoms. RSI is an efficient diagnostic tool for LPR/ It is easy to use, even for those who know little about LPR. It does not require special equipment or examinations and is inexpensive. Thus, it can be considered highly efficient and cost-effective. The study will focus on translating and testing the RSI into Kazakh language and comparing its results in healthy people and people with laryngopharyngeal reflux.

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Key information

Conditions

Laryngopharyngeal Reflux Symptoms Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastro Esophageal Reflux Disease Gastroesophageal Reflux Gastrointestinal Diseases Infections Laryngeal Diseases Laryngitis Laryngopharyngeal Reflux Laryngopharyngitis Chronic Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SOS Medical Assistance, Almaty, Kazakhstan

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient's informed consent;
  • Age: 18-74 years old;
  • No serious somatic diseases;
  • Patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching;
  • Diagnosis: Chronic pharyngitis;
  • Chronic laryngitis.

Exclusion criteria

  • Disagreement to participate in scientific research;
  • Age: under 18 and over 74;
  • Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs;
  • Patients with pulmonary pathologies;
  • Patients with allergic manifestations (chronic or allergic rhinosinusitis and nasal polyposis);
  • With diagnoses: Acute respiratory diseases;
  • Patients with general neuralgic disorders;
  • Pregnancy;
  • Benign lesions of the vocal cords;
  • Acid-suppressive therapy within 4 weeks prior to recruitment

Treatment and study plan

Reflux Symptom Index Inventory (diagnostic survey)

Other

Kazakh versions of the Reflux Symptom Index Inventory will be filled patients

Other names: RSI

Reflux finding score

Other

laryngoscopy with a score RFS

Other names: RFS

Primary outcomes

  1. RSI Score at Baseline:

    Time frame: RSI Score at Baseline

    Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.

  2. RSI Score at Days 10-14

    Time frame: Days 10-14

    Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.

  3. RFS Score at Baseline:

    Time frame: RFS Score at Baseline

    Device: Endoscopic laryngoscopy Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.

  4. RFS Score at Days 10-14

    Time frame: Days 10-14

    Device: Endoscopic laryngoscopy Video laryngoscopy and assessment of the presence / severity of the symptoms - Reflux finding score and will be used as a gold standard of diagnosis of laryngopharengeal reflux. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.

  5. Reliability and validity of RSI at Baseline:

    Time frame: RSI Score at Baseline

    Reliability and validity of RSI at Baseline using Cronbach's alpha test to check the internal consistency for all the 9 items. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.

  6. Reliability and validity of RSI at Days 10-14.

    Time frame: Days 10-14

    Reliability and validity of RSI at Days 10-14 using Cronbach's alpha test to check the internal consistency for all the 9 items. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.

  7. Laryngopharyngeal reflux diagnosis at baseline

    Time frame: Baseline

    Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.

  8. Laryngopharyngeal reflux diagnosis at Days 10-14.

    Time frame: Days 10-14

    Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.

  9. Test - retest reliability of the RSI questtionaire

    Time frame: Days 10-14

    Test - retest reliability of the RSI questtionaire at Days 10-14. Test-retest reliability coefficients vary between 0 and 1, where:

    1 : perfect reliability,

    0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).

  10. Test - retest reliability of the RFS

    Time frame: Days 10-14

    Test - retest reliability of the RFS questtionaire at Days 10-14. Test-retest reliability coefficients vary between 0 and 1, where:

    1 : perfect reliability,

    0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).

Sponsors and collaborators

Lead sponsor

Kazakh Medical University of Continuing Education

Other

Collaborators

  • Asfendiyarov Kazakh National Medical University

Registry information

Official study title

Validity and Reliability of a Kazakh Version of Reflux Symptom Index

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2022
Registry last updated
May 23, 2022

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

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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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