Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06804720
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2025-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-Compassion Against Burnout in Dentistry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Compassion Scale', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'The 6 subscales that comprise the 26-item self-compassion scale are self-kindness, self-judgment , common humanity , isolation , mindfulness and over-identification Participants indicate their responses to each item using a 5-point scale ranging from 1 (Almost Never) to 5 (Almost Always). Higher score indicates greater self-compassion.'}], 'secondaryOutcomes': [{'measure': 'Saliva Cortisol', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Saliva sampling for the daily cortisol curve was scheduled for both the test and control groups. For the test group, samples were collected before the commencement of the MBCL (Mindfulness-Based Compassionate Living) training (T1) and after its completion (T2). For the control group, saliva collection was aligned with the same time periods with the test group. Samples were collected five times per day at specific time points: 30 minutes after waking, at 10:00 AM, 12:00 PM, 5:00 PM, and 10:00 PM (with group reminders provided at designated times). Salivary cortisol was estimated by solid phase enzyme-linked immunosorbent assay (ELISA) (DiaMetra, Boldon, UK) in ng/ml. The procedure was done as per the manufacturer guidelines on saliva samples.'}, {'measure': 'Saliva IL 6', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'IL-6 levels were measured in pg/ml using the commercial kit ELISA according to the instructions of the producer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Self Compassion', 'Mindfulness Meditation', 'Burn Out (Psychology)']}, 'descriptionModule': {'briefSummary': 'Although studies have highlighted the relationship between stress-related psychopathological symptoms and changes in biochemical parameters, no study in dentistry has concurrently evaluated the association of stress and relaxation with biochemical markers and psychological parameters. Moreover, the impact of mindfulness-based self-compassion training programs on these variables has yet to be explored within this context. To enhance the well-being of dentists, an evaluation of a test group participating in an 8-week Mindfulness-Based Compassionate Living (MBCL) program was conducted. This assessment included daily cortisol curves, as well as salivary IL-6, IL-1β, and oxytocin levels. Additionally, empathy, burnout, self-compassion, depression, and mindfulness levels were measured before and after the training. In this study, the main hypothesis was that, compared to the control group, the test group would exhibit lower IL-1β, IL-6, and cortisol levels, along with higher oxytocin levels. Furthermore, as the secondary hypotheses was that the test group would demonstrate increased empathy, self-compassion, and mindfulness levels, accompanied by reductions in depression and burnout scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dentists in their final year of specialty training at the Faculty of Dentistry,\n* systemicaly healthy\n\nExclusion Criteria:\n\n* individuals who received a diagnosis of mood disorders based on DSM-5 criteria following a standard diagnostic assessment conducted by psychiatrists from the Department of Psychiatry'}, 'identificationModule': {'nctId': 'NCT06804720', 'briefTitle': 'Self-Compassion Against Burnout in Dentistry', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Self-Compassion as a Well-Being Strategy Against Occupational Burnout in Dentistry: A Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Cukurova University DHF-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group (Self Compassion Training group)', 'interventionNames': ['Behavioral: Mindfulness based Self compassion']}, {'type': 'NO_INTERVENTION', 'label': 'Control group (No training)'}], 'interventions': [{'name': 'Mindfulness based Self compassion', 'type': 'BEHAVIORAL', 'description': 'All participants in the test group completed the 8-week MBCL (Mindfulness-Based Compassionate Living) training, consisting of 2-hour sessions per week, in accordance with the MBCL training protocol. Training was conducted by one expert periodontist who is also an internationally certified MBCL instructor', 'armGroupLabels': ['Test group (Self Compassion Training group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01130', 'city': 'Adana', 'state': 'Balcali', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova UNiversity faculty of dentistry', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Cenk Haytac', 'investigatorAffiliation': 'Cukurova University'}}}}