Clinical trial NCT06328894: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients
Official title: A Randomized Controlled Trial to Explore the Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic 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, myasthenia gravis, 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: day 1 and day 15 and day 60
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Adult Profile
timeFrame: day 1 and day 15 and day 60
measure: Stroke Self-Efficacy Questionnaire
timeFrame: day 1 and day 15 and day 60
measure: Visual Analog Scale for Fatigue
timeFrame: day 1 and day 15 and day 60
measure: Visual Analog Scale for Nausea
timeFrame: day 1 and day 15 and day 60
Other outcomes:
Locations:
city: Zhenzhou
country: China
facility: Department of rehabilitation medicine, the first ZU hospital north campus
city: Zhenzhou
country: China
facility: Department of rehabilitation medicine, the first ZU hospital western campus
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis
role: STUDY_CHAIR
References: