Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06297018
Status:
TERMINATED
Last Update Posted:
2024-03-06
First Post:
2024-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioenergy, Depression, Anxiety and Stress After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Experimental'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Interventional Crossover Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'whyStopped': 'Data collect completed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2024-02-18', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63)', 'timeFrame': 'total of six month', 'description': "It will be measure Therapy on Liver Transplant Recipients'"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biyoenergy', 'anxiety', 'stress', 'liver transplant recipients'], 'conditions': ['Mental Health Issue']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation.', 'detailedDescription': 'Simple random sampling method was used to assign liver recipients to experimental and control groups. Discharged liver transplant patients will be investigated for anxiety, stress and depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(i) liver transplant recipient (ii) must be able to use immunosuppressive agents (iii) 18 years or older Liver transplant recipients\n\nExclusion Criteria:\n\nhaving psychiatric problems having language and communication problems'}, 'identificationModule': {'nctId': 'NCT06297018', 'briefTitle': 'Bioenergy, Depression, Anxiety and Stress After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Aydın University'}, 'officialTitle': 'The Effect of Bioenergy Application', 'orgStudyIdInfo': {'id': 'February 18, 2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'No intervention: This group includes liver transplant recipients and no intervention is applied to this group. Depression, anxiety and stress levels are measured in the pre-test. No intervention is implemented. As a post-test, depression, anxiety and stress levels are measured again.'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Bioenergy group: This group includes liver transplant recipients and recipients who underwent intervention. Depression, anxiety and stress levels are measured in the pre-test. Bioenergy is then applied. As a post-test, depression, anxiety and stress levels are measured again.', 'interventionNames': ['Behavioral: Bioenergy application']}], 'interventions': [{'name': 'Bioenergy application', 'type': 'BEHAVIORAL', 'otherNames': ['Bio fields'], 'description': 'Bioenergy application: This group includes liver transplant recipients and recipients who underwent intervention. Depression, anxiety and stress levels are measured in the pre-test. Bioenergy is then applied. As a post-test, depression, anxiety and stress levels are measured again.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Semra Bulbuloglu', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Aydın University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'SEMRA BÜLBÜLOĞLU', 'investigatorAffiliation': 'Istanbul Aydın University'}}}}