Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06328894
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2024-03-10
Is NOT Gene Therapy:
True
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'}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2024-03-10', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'day 1 and day 15 and day 60', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Patient-Reported Outcomes Measurement Information System Adult Profile', 'timeFrame': 'day 1 and day 15 and day 60', 'description': '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.'}, {'measure': 'Stroke Self-Efficacy Questionnaire', 'timeFrame': 'day 1 and day 15 and day 60', 'description': '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.'}, {'measure': 'Visual Analog Scale for Fatigue', 'timeFrame': 'day 1 and day 15 and day 60', 'description': '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.'}, {'measure': 'Visual Analog Scale for Nausea', 'timeFrame': 'day 1 and day 15 and day 60', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, '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': 'NCT06328894', 'briefTitle': 'Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Chao Phya Abhaibhubejhr Hospital'}, 'officialTitle': 'A Randomized Controlled Trial to Explore the Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients', 'orgStudyIdInfo': {'id': 'IOE Psychological'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding', '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': ['Device: Intermittent Oro-esophageal Tube Feeding', 'Behavioral: comprehensive rehabilitation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comprehensive rehabilitation therapy+Nasogastric Tube Feeding', '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': ['Device: Nasogastric Tube Feeding', 'Behavioral: comprehensive rehabilitation therapy']}], 'interventions': [{'name': 'Nasogastric Tube Feeding', 'type': 'DEVICE', 'description': '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': ['comprehensive rehabilitation therapy+Nasogastric Tube Feeding']}, {'name': 'Intermittent Oro-esophageal Tube Feeding', 'type': 'DEVICE', 'description': "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': ['comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding']}, {'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': ['comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding', 'comprehensive rehabilitation therapy+Nasogastric Tube Feeding']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhenzhou', 'country': 'China', 'facility': 'Department of rehabilitation medicine, the first ZU hospital north campus', 'geoPoint': {'lat': 32.28034, 'lon': 119.16999}}, {'city': 'Zhenzhou', 'country': 'China', 'facility': 'Department of rehabilitation medicine, the first ZU hospital western campus', 'geoPoint': {'lat': 32.28034, 'lon': 119.16999}}], 'overallOfficials': [{'name': 'Nieto Luis', 'role': 'STUDY_CHAIR', 'affiliation': 'Site Coordinator of United Medical Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copka Sonpashan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The Research Director', 'investigatorFullName': 'Copka Sonpashan', 'investigatorAffiliation': 'Chao Phya Abhaibhubejhr Hospital'}}}}