Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 10:19 AM
Study NCT ID:
NCT07382492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effect of Swedish Massage Versus Adjuvant Yoga on Blood Glucose Level in Children With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': '6 weeks', 'description': 'measures sugar in your blood after an 8-12 hour fast (only water allowed), primarily to check for diabetes or prediabetes by showing your baseline sugar levels, with normal being under 100 mg/dL, prediabetes 100-125 mg/dL, and diabetes 126 mg/dL or higher on two separate tests,'}], 'secondaryOutcomes': [{'measure': 'Random Blood sugar', 'timeFrame': '6 weeks', 'description': 'measures blood sugar levels at any time, without fasting, to screen for diabetes, with normal for healthy adults generally under 140 mg/dL (7.8 mmol/L). Levels between 140-199 mg/dL suggest prediabetes, while 200 mg/dL or higher often indicates diabetes,'}, {'measure': 'Glycosylated Hemoglobin (HbA1c).', 'timeFrame': '6 weeks', 'description': 'a blood test measuring average blood sugar levels over the past 2-3 months by showing the percentage of sugar-coated hemoglobin in red blood cells,'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Swedish massage , Yoga , Type 1 diabetes mellitus'], 'conditions': ['Type 1 Diabetes', 'Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "Swedish massage (SM) and yoga are complementary non-pharmacological techniques that have recently been used in managing chronic disorders such as type 1 diabetes mellitus (T1DM). Both techniques play an important role in reducing stress, which contributes to lowering blood glucose levels in children with T1DM. Objective: To investigate the effect of Swedish massage versus children's yoga exercises on blood glucose levels of children with T1DM", 'detailedDescription': "Swedish massage (SM) and yoga are complementary non-pharmacological techniques that have recently been used in managing chronic disorders such as type 1 diabetes mellitus (T1DM). Both techniques play an important role in reducing stress, which contributes to lowering blood glucose levels in children with T1DM. Objective: To investigate the effect of Swedish massage versus children's yoga exercises on blood glucose levels of children with T1DM\n\nProgressive muscle relaxation (PMR) is one of the best effective non-pharmacological techniques, which decreases stress in children because it influences mental and physical conditions. It can be applied by making the muscles maximally strain, and then loosening it until the muscle is relaxed. It is repeated until children acquire complete relaxation (Casman \\& Nurhaeni, 2018).\n\nProgressive muscle relaxation leads to regulation of autonomic nervous system activity that potentially contributes to medical management of T1DM through improving in glycosylated hemoglobin level (HbA1c) (Paschali et al., 2020). Swedish massage and Progressive muscle relaxation had an effective role in decreasing blood glucose level in children with T1DM, so that the pediatric nurse should apply and educate care giver about Swedish massage and PMR techniques (Ismaili et al., 2018)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diabetic children's age: 6 - 12 years.\n* Children who live in Cairo only.\n* Free from other medical disorders as cardiac, renal, or any other metabolic disorder\n\nExclusion Criteria:\n\n* Diabetic children who can't understand the order\n* Diabetic patient's who have medical disorders as cardiac,renal and other metabolic disorders"}, 'identificationModule': {'nctId': 'NCT07382492', 'briefTitle': 'Clinical Effect of Swedish Massage Versus Adjuvant Yoga on Blood Glucose Level in Children With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Al-Zaytoonah University of Jordan'}, 'officialTitle': 'Clinical Effect of Swedish Massage Versus Adjuvant Yoga on Blood Glucose Level in Children With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Swedish massage yoga type 1 DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetic children who received Swedish massage', 'description': 'Twenty-five diabetic children who received Swedish massage in addition to routine nursing care of the unit for diabetes.', 'interventionNames': ['Procedure: Swedish massage in addition to routine nursing care of the unit for diabetes.']}, {'type': 'EXPERIMENTAL', 'label': "Diabetic children who received children's yoga exercises", 'description': "Twenty-five diabetic children who received children's yoga exercises in addition to routine nursing care of the unit for diabetes.", 'interventionNames': ['Procedure: yoga exercises in addition to routine nursing care of the unit for diabetes.']}], 'interventions': [{'name': 'Swedish massage in addition to routine nursing care of the unit for diabetes.', 'type': 'PROCEDURE', 'description': 'Swedish massage in addition to routine nursing care of the unit for diabetes.', 'armGroupLabels': ['Diabetic children who received Swedish massage']}, {'name': 'yoga exercises in addition to routine nursing care of the unit for diabetes.', 'type': 'PROCEDURE', 'description': 'yoga exercises in addition to routine nursing care of the unit for diabetes', 'armGroupLabels': ["Diabetic children who received children's yoga exercises"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '11571', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Outpatient Clinics of Universities and Private Medical Centers in Cairo', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Zaytoonah University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Mohamed Saied Zidan', 'investigatorAffiliation': 'Al-Zaytoonah University of Jordan'}}}}