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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Zeng Changhao
- Locations
- 1
- Primary Endpoint
- Social Functioning Scale
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Social Functioning Scale
Time Frame: 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.
Secondary Outcomes
- Depression(day 1 and day 21)
- Social Support Questionnaire(day 1 and day 21)
- Anxiety(day 1 and day 21)