Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients

Not Applicable

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT06328894
• Lead Sponsor: Copka Sonpashan

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.

Study Timeline

• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-25
• Study Start: 2024-03-27
• Status Verified: 2025-06
• Primary Completion: 2025-06-08
• Study Completion: 2025-06-08
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	day 1 and day 15 and day 60	The Hospital Anxiety and Depression Scale was used to assess the participants' anxiety and depression symptoms. The scale includes two subscales: anxiety and depression, each consisting of 7 items. Each item is scored from 0 to 3. The total score for each subscale could range between 0 and 21. A higher total score indicates more severe symptoms.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System Adult Profile	day 1 and day 15 and day 60	The Patient-Reported Outcomes Measurement Information System Adult Profile was used to assess subjective social isolation This assessment includes 8 items, each scored between 1 and 5. The total score could range from 8 to 40, with higher scores indicating worse subjective social isolation.
Stroke Self-Efficacy Questionnaire	day 1 and day 15 and day 60	The Stroke Self-Efficacy Questionnaire was used to assess self-efficacy in functional independence and self-management.The Stroke Self-Efficacy Questionnaire includes 13 items, each scored between 0 and 10. The total score could range from 0 to 130. A higher score indicates better self-efficacy.
Visual Analog Scale for Fatigue	day 1 and day 15 and day 60	The Visual Analog Scale for Fatigue is used to assess fatigue. It is a horizontal line from 0 to 4. The total score could range from 0 to 4, with higher scores indicating more fatigue.
Visual Analog Scale for Nausea	day 1 and day 15 and day 60	The Visual Analog Scale for Nausea was used to assess recent perceived nausea. It is a horizontal line from 0 to 10, where 0 indicates no nausea and 10 represents unbearable nausea, with higher scores indicating more unbearable nausea.

Trial Locations

Locations (2)

Department of rehabilitation medicine, the first ZU hospital north campus; 🇨🇳 Zhenzhou, China

Department of rehabilitation medicine, the first ZU hospital western campus; 🇨🇳 Zhenzhou, China