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Clinical Trials/NCT06249087
NCT06249087
Recruiting
N/A

A Randomized Controlled Trial to Explore Effect of Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident

Zeng Changhao1 site in 1 country80 target enrollmentFebruary 15, 2024
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Zeng Changhao
Enrollment
80
Locations
1
Primary Endpoint
Generalized Anxiety Disorder 7
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the psychological condition and experience of the two groups.

Detailed Description

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.

Registry
clinicaltrials.gov
Start Date
February 15, 2024
End Date
May 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeng Changhao
Responsible Party
Sponsor Investigator
Principal Investigator

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

  • Age\>18 years.
  • Meeting the diagnostic criteria for ischemic stroke .
  • Dysphagia confirmed by video fluoroscopic Swallowing Study.
  • Clear consciousness.
  • Stable vital signs.

Exclusion Criteria

  • Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, etc.
  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
  • Pregnant or nursing females.

Outcomes

Primary Outcomes

Generalized Anxiety Disorder 7

Time Frame: day 1 and day 15

Generalized Anxiety Disorder-7 is a widely used questionnaire to assess the severity of symptoms related to generalized anxiety disorder. The questionnaire consists of 7 questions, each with different answer options. The respondent needs to select the appropriate answer based on their actual condition and assign a corresponding score. The total score ranges from 0-21, with higher scores indicating more severe symptoms.

Secondary Outcomes

  • The Reintegration to Normal Living Index(day 1 and day 15)
  • Patient Health Questionnaire-9(day 1 and day 15)
  • Self-made questionnaire(day 1 and day 15)

Study Sites (1)

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