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| ID | Type | Description | Link |
|---|---|---|---|
| 14-2020 | Other Identifier | KazMUCE |
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The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire.
Clinical survey, medical history. 2. Objective methods for assessing the patient's condition:
- examination of ENT organs. 3. Laboratory and instrumental research methods: Endoscopic laryngoscopy and video laryngoscopy, pH-metry, acoustic voice analysis.
4.Sociological method. 5. Subjective methods for assessing the condition of the larynx. 6. Аnalysis of the received data
The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire.
Clinical survey, medical history 2. Objective methods for assessing the patient's condition:
- examination of ENT organs: rhinoscopy, otoscopy, pharyngoscopy and laryngoscopy 3. Laboratory and instrumental research methods - Endoscopic laryngoscopy and video laryngoscopy. pH-metry: The collection of mucus from the laryngopharynx for the determination of acid-base values. Acoustic voice analysis: objective assessment of the voice condition 4.Sociological method: determination of lifestyle, nutrition, the presence or absence of bad habits.
5. Subjective methods for assessing the condition of the larynx - Questionnaires.
6. Аnalysis of the received data
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main group | Experimental | 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. |
|
| Control group 1 | Experimental | Patients with an early diagnosis of Gastroesophageal reflux disease |
|
| Control group 2 | Experimental | Patients without 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pH metry | Diagnostic Test | The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acidity level of the main group, Week 0 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity. | at the inclusion to the study |
| Acidity level of the control group 1, Week 0 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity. | at the inclusion to the study |
| Acidity level of the control group 2, Week 0 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity. | at the inclusion to the study |
| "Index of reflux symptoms" of the main group, Week 0 | 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. | at the inclusion to the study |
| "Index of reflux symptoms" of the control group 1, Week 0 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acidity level of the main group, Week 4 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic. | at 4 weeks after initial treatment |
| Acidity level of the control group 1, Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nukusbekova | Doctor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOS Medical Assistance | Almaty | Kazakhstan | ||||
| V-ent |
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| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| D005764 | Gastroesophageal Reflux |
| D007827 | Laryngitis |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Filling out the questionnaire | Diagnostic Test | Completion of the questionnaire index of reflux symptoms. 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. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem |
|
| Endoscopic laryngoscopy | Device | Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem |
|
| Acoustic voice analysis | Device | acoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves |
|
| at the inclusion to the study |
| "Index of reflux symptoms" of the control group 2, Week 0 | 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. | at the inclusion to the study |
| Endoscopic laryngoscopy of the main group, Week 0 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at the inclusion to the study |
| Endoscopic laryngoscopy of the control group 1, Week 0 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at the inclusion to the study |
| Endoscopic laryngoscopy of the control group 2, Week 0 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at the inclusion to the study |
| Acoustic voice analysis of the main group, Week 0 | Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves. | at the inclusion to the study |
The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic. |
| at 4 weeks after initial treatment |
| Acidity level of the control group 2, Week 4 | The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic. | at 4 weeks after initial treatment |
| "Index of reflux symptoms" of the main group, Week 4 | 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. | at 4 weeks after initial treatment |
| "Index of reflux symptoms" of the control group 1, Week 4 | 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. | at 4 weeks after initial treatment |
| "Index of reflux symptoms" of the control group 2, Week 4 | 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. | at 4 weeks after initial treatment |
| Endoscopic laryngoscopy of the main group, Week 4 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at 4 weeks after initial treatment |
| Endoscopic laryngoscopy of the control group 1, Week 4 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at 4 weeks after initial treatment |
| Endoscopic laryngoscopy of the control group 2, Week 4 | Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. | at 4 weeks after initial treatment |
| Acoustic voice analysis of the main group, Week 4 | Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves | at 4 weeks after initial treatment |
| Almaty |
| Kazakhstan |
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010038 | Otorhinolaryngologic Diseases |