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临床试验/NCT07400822
NCT07400822已完成不适用

İnme Sonrası Yutma Bozukluğu Gelişen Hastalara Erken Dönemde Verilen Ekşi Sıvının Yutma Fonksiyonu Üzerine Etkisinin Değerlendirilmesi

AYFER GUNES1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2021年7月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
1
主要终点
Gugging Swallowing Screen score

研究概览

简要总结

This randomized controlled study was designed to determine the Effect of Sour Taste on Swallowing Function of Patients with Dysphagia After Acute Ischemic Stroke The study was conducted between july 2021 and november 2022 with 95 patients diagnosed with Acute Ischemic Stroke (47 intervention, 48 control) at the neurology clinic and outpatient clinic of a university hospital in Edirne. Data were collected using the Personal Information Form, the Gugging Swallowing Screening Test (GUSS), and the National Institutes of Health Stroke Scale (NIHSS).

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

randomized controlled

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

control

Other

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.

干预措施: Control (Other)

Sour Taste

Experimental

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

干预措施: sour taste (Other)

结局指标

主要结局

Gugging Swallowing Screen score

时间窗: one month

Change in the mean scores of the Gugging Swallowing Screen (GUSS) score of the patients at the first interview, on the 7th day and on the 30th day

National Institutes of Health Stroke Scale score

时间窗: one month

Change in the mean scores of the National Institutes of Health Stroke Scale (NIHSS) of the patients at the first interview, on the 7th day and on the 30th day

GUSS Swallowing scores and NIHSS Scores

时间窗: one month

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.

次要结局

未报告次要终点

研究者

发起方
AYFER GUNES
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

AYFER GUNES

Dr. (PhD), Register Nurse

Trakya University

研究点 (1)

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