- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06265805
Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients (IOE-Xinli)
A Randomized Controlled Trial to Explore the Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Weiji Zhao, Master
- Phone Number: 17839973473
- Email: zwjww2009@163.com
Study Contact Backup
- Name: Zhefeng Wang, Master
- Phone Number: 19501376864
- Email: zhengzhouzhj@qq.com
Study Locations
-
-
-
Xinzhu, Taiwan
- Recruiting
- Hsinchu Rehabilitation Hospital
-
Contact:
- Haim Liu, Master
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: the observation group
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups |
The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water.
During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall.
The distance from the incisors to the head part of the tube should be between 22-25 cm.
However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly.
After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation.
Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. |
Active Comparator: the control group
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. Besides, the control group was given enteral nutritional support with Nasogastric Tube according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. |
The control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines.
Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the patient's cheek with medical tape.
The feeding was conducted once every 3-4 hours, with 200-300ml each time.
The total feeding volume was determined based on daily requirements.
The feeding content was formulated by the nutritionists based on the patient's condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0
g/kg/day for both two groups.
For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
day 1 and day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9
Time Frame: day 1 and day 15
|
The total score of the Patient Health Questionnaire-9 ranges from 0 to 27, with higher scores indicating more severe depression symptoms.
|
day 1 and day 15
|
Self-made questionnaire
Time Frame: day 1 and day 15
|
By conducting a self-made questionnaire, we can assess patients' feelings of fear, shame, uncertainty, and other emotions related to tube feeding.
The scores are then converted to a percentage scale ranging from 0 to 100.
In the Likert 5-point scale, higher scores indicate worse and more severe conditions for each question.
|
day 1 and day 15
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-KY-0125-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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