Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT06245733
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Effect of Compassion-Based Education Program Applied to Mothers of Children Diagnosed With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment and Evaluation of Depression', 'timeFrame': 'Day 1', 'description': 'Burns Depression Scale will be applied to all participants. Depression levels will be determined.'}, {'measure': 'Assessment and Evaluation of Psychological Resilience', 'timeFrame': 'Day 1', 'description': 'Psychological Resilience Scale for Adults will be applied to all participants. Psychological Resilience levels will be determined.'}, {'measure': 'Assessment and Evaluation of Compassion', 'timeFrame': 'Day 1', 'description': 'Compassion Scale will be applied to all participants. Compassion levels will be determined .'}], 'secondaryOutcomes': [{'measure': 'The last test of Assessment and Evaluation of Depression', 'timeFrame': 'through study completion, an average of 1 week.', 'description': 'Burns Depression Scale will be applied to all participants. Depression levels will be determined due to showing effectiveness of training.'}, {'measure': 'The last test of Assessment and Evaluation of Psychological Resilience', 'timeFrame': 'through study completion, an average of 1 week.', 'description': 'Psychological Resilience Scale will be applied to all participants. Resilience levels will be determined due to showing effectiveness of training.'}, {'measure': 'The last test of Assessment and Evaluation Compassion', 'timeFrame': 'through study completion, an average of 1 week.', 'description': 'Compassion Scale will be applied to all participants. Compassion levels will be determined due to showing effectiveness of training.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serebral Palsi', 'Depression', 'Resilience', 'Compassion'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Purpose of the study; The aim of this study is to examine the effect of a compassion-based education program applied to mothers of children with cerebral palsy on compassion fatigue, depression, and psychological resilience.', 'detailedDescription': 'The Hypotheses of the Study\n\nMain Hypothesis: "Compassion-Based Education Program Adapted for Adults" in increasing the compassion levels and psychological resilience of mothers of patients with CP; It is effective in reducing the level of depression.\n\nAs sub-hypotheses:\n\nH1: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Adult Compassion Scale are significantly higher than the scores they obtained before the application (pre-test).\n\nH2: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Burns Depression Scale-Turkish Form are significantly lower than the scores they obtained before the application (pre-test).\n\nH3: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Adult Resilience Scale are significantly higher than the scores they obtained before the application (pre-test).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being the mother of a child with Cerebral Palsy\n\nExclusion Criteria:\n\n* Mothers who have children with Cerebral Palsy do not want to participate in the study and want to leave the study.'}, 'identificationModule': {'nctId': 'NCT06245733', 'briefTitle': 'Study of the Effect of Compassion-Based Education Program Applied to Mothers of Children Diagnosed With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'Investigation of the Effect of Compassion-Based Education Program Applied to the Mothers of Children Diagnosed With Cerebral Palsy on Compassion, Depression and Resilience', 'orgStudyIdInfo': {'id': 'MSEVEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Participants who will receive the training', 'interventionNames': ['Other: Compassion-Based Education Program Adapted for Adults']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'participants who will not be interfered with'}], 'interventions': [{'name': 'Compassion-Based Education Program Adapted for Adults', 'type': 'OTHER', 'description': 'Training will be given once a week. This training will last 10 weeks in total.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Gaziantep', 'state': 'Central', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sezer Avcı, 1', 'role': 'CONTACT', 'email': 'sezer.avci@hku.edu.tr', 'phone': '+90-506-856-0446'}], 'facility': 'Hasan Kalyoncu University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'centralContacts': [{'name': 'Murat SEVEN, 1', 'role': 'CONTACT', 'email': 'murat.seven@std.hku.edu.tr', 'phone': '+90-501-131-8007'}, {'name': 'Sezer AVCI, 1', 'role': 'CONTACT', 'email': 'sezer.avci@hku.edu.tr', 'phone': '+90-506-856-0446'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Murat SEVEN', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}