[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654307":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":56,"overallOfficials":41,"centralContacts":62,"locations":68,"responsibleParty":81,"collaborators":41,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":41,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":41,"studyType":98,"phases":99,"briefSummary":100,"conditions":101,"keywords":108,"overallStatus":116,"whyStopped":41,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Universitas Diponegoro","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":41},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Change in Monocyte-to-Lymphocyte Ratio (MLR)","Changes in MLR derived from routine complete blood count to evaluate systemic inflammation.","Baseline and Day 8 (post-intervention)",{"measure":14,"description":15,"timeFrame":12},"Change in Neutrophil-to-Lymphocyte Ratio (NLR)","Changes in NLR derived from routine complete blood count to evaluate systemic inflammation",{"measure":17,"description":18,"timeFrame":12},"Change in Platelet-to-Lymphocyte Ratio (PLR)","Changes in PLR derived from routine complete blood count to evaluate systemic inflammation.",{"measure":20,"description":21,"timeFrame":12},"Change in DASS-21 Score","Evaluation of changes in psychological distress using the Depression, Anxiety, and Stress Scale-21 (DASS-21). Total score ranges from 0 to 63, where higher scores indicate higher levels of psychological distress.",{"measure":23,"description":24,"timeFrame":12},"Change in Beck Depression Inventory (BDI) Score","Evaluation of changes in depressive symptoms using the BDI questionnaire. Total score ranges from 0 to 63, where higher scores indicate more severe depression.",{"measure":26,"description":27,"timeFrame":12},"Change in Patient Health Questionnaire-9 (PHQ-9) Score","Evaluation of depression severity using the PHQ-9 scale. Total score ranges from 0 to 27, where higher scores indicate more severe depressive symptoms.",[29,32,35,38],{"measure":30,"description":31,"timeFrame":12},"Change in Pittsburgh Sleep Quality Index (PSQI) Score","Evaluation of sleep quality using the PSQI questionnaire. Total score ranges from 0 to 21, where higher scores indicate poorer sleep quality.",{"measure":33,"description":34,"timeFrame":12},"Change in Connor-Davidson Resilience Scale (CD-RISC) Score","Evaluation of psychological resilience levels using the CD-RISC questionnaire. Total score ranges from 0 to 100, where higher scores indicate greater resilience.",{"measure":36,"description":37,"timeFrame":12},"Change in Impact of Event Scale-Revised (IES-R) Score","Evaluation of post-traumatic stress distress related to the tidal flood disaster using the IES-R. Total score ranges from 0 to 88, where higher scores indicate greater post-traumatic distress.",{"measure":39,"description":40,"timeFrame":12},"Change in WHOQOL-BREF Score","Evaluation of quality of life across physical, psychological, social, and environmental domains using the WHOQOL-BREF scale. Domain scores are transformed to a scale of 0 to 100, where higher scores indicate higher quality of life.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NA","SINGLE_GROUP","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE","Background:\n\nCoastal communities in Sayung District, Demak Regency, face recurrent tidal flooding (rob) that causes continuous environmental and economic pressure. From a psychoneuroimmunological perspective, chronic psychosocial stress triggers systemic low-grade inflammation. Biomarkers such as MLR, NLR, and PLR serve as accessible systemic inflammatory indices that correlate with mood disorders and stress severity. Mindfulness body scan training aims to improve interoceptive awareness, emotional regulation, and parasympathetic activity, thereby reducing stress reactivity and systemic inflammation.\n\nStudy Design and Objectives:\n\nThis is an interventional pre-post experimental study conducted at the Sayung 1 Public Health Center (Puskesmas Sayung 1), Demak. The study evaluates changes in systemic inflammatory markers and psychological parameters pre- and post-intervention.\n\nIntervention:\n\nParticipants will participate in a structured mindfulness body scan program over an 8-day period. The body scan protocol guides participants to direct attention sequentially to various body regions without judgment to enhance somatic awareness and stress mitigation.\n\nAssessments:\n\n1. Laboratory Testing: Complete blood counts to determine monocyte, neutrophil, platelet, and lymphocyte ratios (MLR, NLR, PLR) pre- and post-intervention.\n2. Psychometric Evaluations: Assessment of psychological symptoms using validated tools, including:\n\n   * Beck Depression Inventory (BDI) \\& Patient Health Questionnaire-9 (PHQ-9)\n   * Depression, Anxiety, and Stress Scale-21 (DASS-21)\n   * Impact of Event Scale - Revised (IES-R) \\& PTSD Checklist-5 (PCL-5)\n   * Pittsburgh Sleep Quality Index (PSQI)\n   * Connor-Davidson Resilience Scale (CD-RISC)\n   * Spiritual Wellbeing Scale (SWBS)\n   * Fatigue Assessment Scale (FAS)\n   * WHO Quality of Life (WHOQOL)\n   * Perceived Social Performance (PSP)\n\nData Analysis:\n\nPre- and post-intervention data will be analyzed using paired statistical tests and multivariate regression to determine changes in inflammatory markers and psychological scores, as well as the correlation between systemic inflammation changes and psychological recovery.",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"Mindfulness Body Scan Group","EXPERIMENTAL","Participants in this single arm receive an 8-day community-based mindfulness body scan training designed to evaluate its effects on systemic inflammatory markers (MLR, NLR, PLR) and psychological parameters.",[55],"Behavioral: Mindfulness Body Scan",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":41},"BEHAVIORAL","Mindfulness Body Scan","A structured 8-day behavioral intervention consisting of guided mindfulness body scan practices. Participants are instructed to direct non-judgmental attention sequentially across different regions of the body to enhance somatic awareness, promote relaxation, and reduce psychological stress reactivity.",[51],[63],{"name":64,"role":65,"phone":66,"phoneExt":41,"email":67},"Natalia Dewi Wardani Dr. dr. Sp.KJ(K)","CONTACT","+6281325683134","anatdew@gmail.com",[69],{"facility":70,"status":41,"city":71,"state":72,"zip":41,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":41},"Puskesmas Sayung 1","Demak","Central Java","Indonesia","ID",{"type":76,"coordinates":77},"Point",[78,79],110.6396,-6.8909,{"lat":79,"lon":78},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Natalia Dewi Wardani, MD","Head of Psychiatry Residency Program Medical Faculty Diponegoro University, Principal Investigator","100654307","the-effect-of-mindfulness-in-inflammation-markers-mlr-nlr-plr-stress-anxiety-and-depression-rate-among-survivors-of-tidal-flooding-in-sayung-demak-100654307",false,"NCT07796919","The Effect of Mindfulness in Inflammation Markers (MLR, NLR, PLR), Stress, Anxiety, and Depression Rate Among Survivors of Tidal Flooding in Sayung Demak","Inclusion Criteria:\n\n* Adults aged 18 to 60 years.\n* Survivors of tidal flooding (bencana rob) residing in the Sayung coastal area for at least 6 months.\n* Minimum educational attainment of Primary School (Sekolah Dasar \u002F SD).\n* Literate in Indonesian (able to read and write).\n* Willing to participate in and complete the 8-day mindfulness intervention program.\n* Physically independent and capable of completing self-administered questionnaires.\n\nExclusion Criteria:\n\n* Active psychotic disorders or severe mental illness.\n* Cognitive impairment that limits ability to complete assessments.\n* History of diagnosed autoimmune disorders, active allergies, or chronic inflammatory diseases.\n* Presence of acute infectious disease symptoms within the past 1 month.\n* Currently undergoing formal psychotherapy or other structured psychological interventions.",true,"ALL","18 Years","60 Years",{"count":96,"type":97},70,"ESTIMATED","INTERVENTIONAL",[43],"Tidal flood disasters in coastal areas cause chronic psychological stress due to economic, social, and residential disruption. Psychological stress is closely linked to systemic inflammatory responses-marked by elevated Monocyte-to-Lymphocyte Ratio (MLR), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR)-which are associated with depression and anxiety symptoms. Mindfulness interventions, particularly body scan techniques, have been shown to reduce psychological distress and modulate immune responses, but empirical evidence on coastal flood survivors in Indonesia remains limited.\n\nThis study aims to evaluate the effectiveness of a community-based mindfulness body scan intervention on inflammatory biomarkers (MLR, NLR, PLR) and psychological parameters (stress, depression, anxiety, trauma, sleep quality, and resilience) among tidal flood survivors in Sayung, Demak. Participants will undergo baseline blood work and psychometric assessments, receive an 8-day mindfulness body scan intervention, and complete post-intervention evaluations.",[102,103,104,105,106,107],"Psychological Stress","Depression - Major Depressive Disorder","Anxiety","Post-traumatic Stress Symptoms","Inflammation","Survivor",[109,110,111,112,113,104,114,115],"Mindfulness","MLR","NLR","PLR","Stress","Depression","Flood","NOT_YET_RECRUITING","2026-08-27",{"date":119,"type":120},"2026-09-01","ACTUAL",{"date":119,"type":97},{"date":123,"type":97},"2027-04-01",{"name":83,"class":6},1]