Clinical trial NCT05296655: Kazakh Version of Reflux Symptom Index
Official title: Validity and Reliability of a Kazakh Version of Reflux Symptom Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngopharyngeal Reflux Symptoms
Laryngopharyngitis Chronic
Gastro Esophageal Reflux Disease
Keywords: Laryngopharyngeal Reflux
Laryngopharyngeal Reflux Symptoms
Laryngitis
Laryngopharyngitis Chronic
Gastro Esophageal Reflux
Lead sponsor: Kazakh Medical University of Continuing Education
Sponsor class: OTHER
Collaborators: name: Asfendiyarov Kazakh National Medical University
First posted: 2022-03-25
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients between 18 to 74 years of age with a laryngopharengeal symptoms and patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist/

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: RSI Score at Baseline:
timeFrame: RSI Score at Baseline
measure: RSI Score at Days 10-14
timeFrame: Days 10-14
measure: RFS Score at Baseline:
timeFrame: RFS Score at Baseline
measure: RFS Score at Days 10-14
timeFrame: Days 10-14
measure: Reliability and validity of RSI at Baseline:
timeFrame: RSI Score at Baseline
measure: Reliability and validity of RSI at Days 10-14.
timeFrame: Days 10-14
measure: Laryngopharyngeal reflux diagnosis at baseline
timeFrame: Baseline
measure: Laryngopharyngeal reflux diagnosis at Days 10-14.
timeFrame: Days 10-14
measure: Test - retest reliability of the RSI questtionaire
timeFrame: Days 10-14
measure: Test - retest reliability of the RFS
timeFrame: Days 10-14
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: SOS Medical Assistance
city: Almaty
country: Kazakhstan
facility: V-ent
Study officials:
affiliation: Doctor
name: Nukusbekova
role: PRINCIPAL_INVESTIGATOR
References: