A Randomized Controlled Trial To Explore the Effect of Oral vs. Nasal Enteral Nutrition Tube Feeding on Stroke Survivors in Social Interaction and Psychological Status
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Social Functioning Scale
研究概览
简要总结
The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:
Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.
详细描述
Stroke is happening increasingly more. The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:
Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years;
- •meeting the diagnostic criteria of stroke;
- •any degree of dysphagia at admission;
- •steady vital signs, without severe cognitive impairment or sensory aphasia.
- •transferred out within three weeks of hospitalization in the neurology department.
排除标准
- •complicated with other neurological diseases;
- •damaged mucosa or incomplete structure in nasopharynx;
- •tracheostomy tube plugged;
- •unfeasible to the support of parenteral nutrition;
- •simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
研究组 & 干预措施
comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding
Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The experimental group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding.
干预措施: comprehensive rehabilitation therapy (Behavioral)
comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding
Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The experimental group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding.
干预措施: Intermittent Oro-esophageal Tube Feeding (Device)
comprehensive rehabilitation therapy+Nasogastric Tube Feeding
Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The control group was provided the support of enteral nutrition by Nasogastric Tube Feeding.
干预措施: Nasogastric Tube Feeding (Device)
comprehensive rehabilitation therapy+Nasogastric Tube Feeding
Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The control group was provided the support of enteral nutrition by Nasogastric Tube Feeding.
干预措施: comprehensive rehabilitation therapy (Behavioral)
结局指标
主要结局
Social Functioning Scale
时间窗: day 1 and day 15
The Social Functioning Scale includes multiple subscales, and the score range is generally 0-100. Higher scores indicate better social functioning, while lower scores indicate limited social functioning or problems.
次要结局
- Social Support Questionnaire(day 1 and day 15)
- Anxiety(day 1 and day 15)
- Depression(day 1 and day 15)
研究者
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital