Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT06265805
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-02', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-10', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generalized Anxiety Disorder 7', 'timeFrame': 'day 1 and day 15', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire-9', 'timeFrame': 'day 1 and day 15', 'description': 'The total score of the Patient Health Questionnaire-9 ranges from 0 to 27, with higher scores indicating more severe depression symptoms.'}, {'measure': 'Self-made questionnaire', 'timeFrame': 'day 1 and day 15', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years.\n* Meeting the diagnostic criteria for ischemic stroke .\n* Dysphagia confirmed by Videofluoroscopic Swallowing Study.\n* Clear consciousness.\n* Stable vital signs.\n\nExclusion Criteria:\n\n* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.\n* Complicated with severe liver and kidney failure, tumors, or hematological disorders.\n* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.\n* Pregnant or nursing females.'}, 'identificationModule': {'nctId': 'NCT06265805', 'acronym': 'IOE-Xinli', 'briefTitle': 'Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Zhengzhou University"}, 'officialTitle': 'A Randomized Controlled Trial to Explore the Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients', 'orgStudyIdInfo': {'id': '2024-KY-0125-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the observation group', 'description': 'Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:\n\nBasic treatment, including corresponding control of risk factors and education on healthy lifestyles.\n\nSwallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.\n\nPulmonary function training, including standing training, cough training, and diaphragm muscle training.\n\nThe 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', 'interventionNames': ['Behavioral: comprehensive rehabilitation therapy', 'Device: Intermittent Oro-esophageal Tube Feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the control group', 'description': 'Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:\n\nBasic treatment, including corresponding control of risk factors and education on healthy lifestyles.\n\nSwallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.\n\nPulmonary function training, including standing training, cough training, and diaphragm muscle training.\n\nBesides, 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.', 'interventionNames': ['Behavioral: comprehensive rehabilitation therapy', 'Device: Nasogastric Tube Feeding']}], 'interventions': [{'name': 'comprehensive rehabilitation therapy', 'type': 'BEHAVIORAL', 'description': 'Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.\n\nSwallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.\n\nPulmonary function training, including standing training, cough training, and diaphragm muscle training.', 'armGroupLabels': ['the control group', 'the observation group']}, {'name': 'Intermittent Oro-esophageal Tube Feeding', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['the observation group']}, {'name': 'Nasogastric Tube Feeding', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['the control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xinzhu', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Haim Liu, Master', 'role': 'CONTACT'}], 'facility': 'Hsinchu Rehabilitation Hospital', 'geoPoint': {'lat': 22.46205, 'lon': 120.47335}}], 'centralContacts': [{'name': 'Zhefeng Wang, Master', 'role': 'CONTACT', 'email': 'zhengzhouzhj@qq.com', 'phone': '19501376864'}, {'name': 'Weiji Zhao, Master', 'role': 'CONTACT', 'email': 'zwjww2009@163.com', 'phone': '17839973473'}], 'overallOfficials': [{'name': 'Nieto Luis, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Site Coordinator of United Medical Group located in Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeng Changhao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Zeng Changhao', 'investigatorAffiliation': "People's Hospital of Zhengzhou University"}}}}