- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07400822
Effect of Sour Taste on Swallowing Function of Patients With Dysphagia After Acute Ischemic Stroke: A Randomized Controlled Trial
İnme Sonrası Yutma Bozukluğu Gelişen Hastalara Erken Dönemde Verilen Ekşi Sıvının Yutma Fonksiyonu Üzerine Etkisinin Değerlendirilmesi
Study Overview
Status
Intervention / Treatment
Detailed Description
This study was designed to evaluate the effect of sour taste on swallowing function of patients who developed dysphagia after ischemic stroke.The study sample consisted of patients (n=95) diagnosed with ischemic stroke and had impaired swallowing function hospitalized in a neurology clinic of a university hospital. Patients in the intervention group were given 4 ml of lemon juice (pH=2.8) at room temperature before breakfast, lunch, and dinner, while patients in the control group were given 4 ml of water at room temperature at the same time periods. Patients' swallowing function and stroke severity were assessed on the 7th and 30th days. Data were collected using the Personal Information Form, the Gugging Swallowing Screening Test (GUSS), and the National Institutes of Health Stroke Scale (NIHSS).
Financial Support:The present study was supported by the Research Fund of Trakya University. Project No:2021/214
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Center
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Edirne, Center, Turkey (Türkiye), 22030
- Trakya University Medical Research and Application Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hospitalized with a confirmed diagnosis of ischemic stroke
- Within the first 72 hours after diagnosis
- Developed dysphagia
- Who could understand and cooperate
- Patients who volunteer signed an informed consent
Exclusion Criteria:
- Patients with cerebral hemorrhage or other neurologic disorders
- Patients with severe stroke and high NIHSS scores
- Who were likely to experience severe dysphagia
- Patients who do not volunteer to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: control
The participants were informed about the research process during the first meeting.
Control group patients were administered 4 ml of room temperature water during the initial consultation, under the supervision of a physician, before breakfast, lunch, and dinner.
According to the GUSS screening test, patients with severe dysphagia were given 4 ml of water drop by drop with a syringe, in a manner tolerable to the patient, together with the physician, over approximately 15-20 minutes.
Stroke patients with severe dysphagia, unable to swallow, had the 4 ml of water administered drop by drop but it flowed out of their mouths as saliva.
This procedure was continued for seven days .Patients with dysphagia who had acute ischemic stroke in the control group was evaluated at the first day visit, on the day 7, and day 30.
The initial visit and day 7 evaluations were conducted in a clinical setting because the patients were receiving treatment at the neurology clinic.
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Room-Temperature Water Administration
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Experimental: Sour Taste
The participants were informed about the research process during the first meeting.
Intervention group patients were administered 4 ml of freshly squeezed lemon juice with a hydrogen power (pH) of 2.8 at room temperature under medical supervision before breakfast, lunch, and dinner.
According to the GUSS screening test, patients with severe dysphagia were given 4 ml of lemon juice drop by drop with a syringe, in a manner tolerable to the patient, together with the physician, over approximately 15-20 minutes.
Patients with severe dysphagia, due to their inability to swallow, had the 4 ml of lemon juice administered drop by drop, but it flowed out of their mouths as saliva.
This application continued for seven days.Patients with dysphagia who had acute ischemic stroke in the control group was evaluated at the first day visit, on the day 7, and day 30.
The initial visit and day 7 evaluations were conducted in a clinical setting because the patients were receiving treatment at the neurolo
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Sour taste stimulation using freshly squeezed lemon juice administered orally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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GUSS Swallowing scores and NIHSS Scores
Time Frame: one month
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Change in the mean scores of the GUSS swallowing scores and NIHSS Scores of the patients at the first interview, on the 7th day and on the 30th day.
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one month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayfer Gunes, PhD, RN., Trakya University Medical Research and Application Centre, Department of Neurology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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