Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01518218
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2012-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Laying-on-of-hands for Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019124', 'term': 'Therapeutic Touch'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2012-01-21', 'studyFirstSubmitQcDate': '2012-01-21', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-related episodes and mortality', 'timeFrame': '3 years and 9 months'}], 'secondaryOutcomes': [{'measure': 'blood data', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sickle cell disease', 'laying-on-of-hands', 'morbidity', 'mortality'], 'conditions': ['Sickle Cell Disease', 'Pain Crisis Recurrent', 'Anemia', 'Infection', 'Death']}, 'referencesModule': {'references': [{'pmid': '24445353', 'type': 'DERIVED', 'citation': 'Minga TM, Koto FK, Egboki H, Suzuki K. Effectiveness of biofield therapy for individuals with sickle cell disease in Africa. Altern Ther Health Med. 2014 Jan-Feb;20(1):20-6.'}], 'seeAlsoLinks': [{'url': 'http://www.moainternational.or.jp', 'label': 'MOA International Corporation'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in Africa.', 'detailedDescription': 'Patients with sickle cell disease (SCD) have a high risk of premature death in Africa, mainly due to insufficient medical services. SCD patients often visit emergency department and need hospitalization when they suffer from severe pain; however, they manage most of painful episodes at home. Appropriate pain management at home is, therefore, crucial to improve their clinical course and quality of life. Laying-on-of-hands may be a good candidate for home care management, because family member(s) can become a practitioner of laying-on-of-hands without difficulty and administer it to their loved one as an initial treatment whenever necessary. There are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of SCD patients, as far as we have investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with symptoms associated with sickle cell disease\n* those able to receive laying-on-of-hands every weekday for 1 year\n* those able to receive conventional medical treatment whenever necessary\n* those able to receive blood test at the beginning, after 6 month and after 1 year\n\nExclusion Criteria:\n\n* those who wish to use other complementary and alternative therapies along with laying-on-of-hands'}, 'identificationModule': {'nctId': 'NCT01518218', 'briefTitle': 'Effectiveness of Laying-on-of-hands for Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'MOA Health Science Foundation'}, 'officialTitle': 'Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa', 'orgStudyIdInfo': {'id': 'MOA-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laying-on-of-hands', 'description': 'Patients of this arm received laying-on-of-hands twice a day (45 minutes each) every weekday for 1year, and received conventional medical treatment if necessary.', 'interventionNames': ['Behavioral: laying-on-of-hands']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patients of this arm did not receive any alternatives other than conventional treatment.'}], 'interventions': [{'name': 'laying-on-of-hands', 'type': 'BEHAVIORAL', 'otherNames': ['Okada Purifying Therapy', 'biofield therapy'], 'description': 'The intervention group received laying-on-of-hands every weekday for 1 year along with conventional medicine. The control group did not undergo any alternatives to OPT.', 'armGroupLabels': ['laying-on-of-hands']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kinshasa', 'country': 'Democratic Republic of the Congo', 'facility': 'The national medical center for sickle cell disease', 'geoPoint': {'lat': -4.32758, 'lon': 15.31357}}], 'overallOfficials': [{'name': 'Kodondi K Koto, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Institute of Scientific Research for Health, Kinshasa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MOA Health Science Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'president', 'investigatorFullName': 'Kiyoshi Suzuki', 'investigatorAffiliation': 'MOA Health Science Foundation'}}}}