NCT06228183撤回不适用
A Randomized Controlled Trial To Explore the Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagic Stroke Survivors in Social Interaction and Psychological Status
Zeng Changhao1 个研究点 分布在 1 个国家开始时间: 2024年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 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 21 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 21 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
- Supportive Care
- 盲法
- Double (Investigator, 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, able to cooperate with the assessment.
- •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.
结局指标
主要结局
Social Functioning Scale
时间窗: day 1 and day 21
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
- Depression(day 1 and day 21)
- Social Support Questionnaire(day 1 and day 21)
- Anxiety(day 1 and day 21)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University
研究点 (1)
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