Larygopharyngeal Reflux Disease. ??????? ???? ?? ??? ? ?????
Conditions
Interventions
Intervention 1: Intentervention Group 1 (Conventional Medical Treatment + Voice Therapy): In this group, conventional medical treatment, including pharmacotherapy and lifestyle modification, is provid
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
19 Years to 60 Years
Inclusion criteria
Inclusion criteria: A confirmed diagnosis of LPRD by a gastroenterologist, otolaryngologist, or speech-language pathologist based on history taking; the presence of symptoms such as persistent throat clearing, chronic cough, globus sensation, and voice changes; results of the Reflux Symptom Index (RSI) self-report questionnaire; and Reflux Finding Score (RFS) obtained from laryngovideostroboscopic images. . Age between 19 and 60 years Lack of response to conventional LPRD medical treatment for at least 8 weeks. No history of surgery in the head, larynx, neck, thorax, or abdominal regions No structural laryngeal abnormalities, such as benign or malignant mass lesions, or vocal fold paralysis. No history of other gastrointestinal disorders, based on history taking and examination performed by a gastroenterologist. No history of other inflammatory upper airway diseases within the past month, based on history taking and examination by an otolaryngologist. Female participants must not be pregnant. No excessive alcohol consumption, defined as more than 14 alcohol units per week for men and more than 7 units per week for women No excessive cigarette smoking, defined as smoking twenty or more cigarettes per day for at least the past 12 months Body Mass Index (BMI) between 18.5 and 29.5 kg/m² No major psychiatric disorders.
Exclusion criteria
Exclusion criteria: have structural abnormalities or benign/malignant vocal fold lesions have excessive alcohole consumption and smoking be pregnant have a body mass index (BMI) over 29.5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reflux Finding Score. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Persian version of the Reflux Findings Score (RFS) questionnaire based on findings from laryngeal stroboscopy (laryngeal imaging).;Reflux Symptom Index. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Self-assessment, Persian version of the Reflux Symptom Index (RSI) questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Voice Handicap Index. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Self-assessment, Persian version of the Voice Handicap Index (VHI) questionnaire.;Anteroposterior and mediolateral supraglottic activity. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Voice–Vibratory Assessment with Laryngeal Imaging based on laryngeal imaging.;Overall auditory-perceptual agreement on voice disorder. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Persian version of the Auditory–Perceptual Voice Evaluation Scale.;Frequency and severity of vocal tract discomfort. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Self-assessment, Persian version of the Vocal Tract Discomfort Scale (VTDS) questionnaire.;Muscle tension of the suprahyoid, thyrohyoid, cricothyroid, and laryngopharyngeus muscles. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Laryngeal palpation rating scale based on Angsuwarangsee and Morrison method.;Anxiety. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Self-assessment, Persian version of the Beck Anxiety Inventory (BAI).;Depression. Timepoint: At baseline (prior to the initiation of the study), at the end of the intervention (30 days after baseline),one month after the intervention. Method of measurement: Self- | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBehnaz Soleimani
Tehran University of Medical Sciences
Outcome results
None listed