The Effect of Mindfulness in Inflammation Markers (IL-6, TNF-A, CRP and Cortisol) Among Survivors of Tidal Flooding in Sayung Demak
Recurrent tidal flooding (rob) in the coastal areas of Sayung District, Demak Regency, poses a continuous environmental threat that inflicts housing damage, economic instability, and prolonged socioeconomic uncertainty on local residents. These chronic stressors frequently trigger significant psychological distress, including elevated levels of stress, anxiety, and depression, while simultaneously activating systemic inflammatory pathways and dysregulating the hypothalamic-pituitary-adrenal (HPA) axis.
Mindfulness body scan is a structured, non-pharmacological mind-body technique that involves directing non-judgmental attention to physical sensations across the body. Within a psycho-neuro-immunological framework, mindfulness practice is hypothesized to reduce physiological stress responses, promote autonomic nervous system balance, and downregulate pro-inflammatory pathways.
This randomized controlled trial evaluates the effectiveness of a structured 8-day mindfulness body scan intervention on both biological inflammatory markers and psychological outcomes among tidal flood survivors. Participants recruited from Sayung 1 Primary Health Center will be randomly allocated into two groups:
- Intervention Group: Receives structured 8-day Mindfulness Body Scan training.
- Control Group: Receives standard health monitoring. All participants will undergo baseline and post-intervention assessments, which include venous blood sampling to analyze key inflammatory and stress biomarkers-Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), C-Reactive Protein (CRP), and Cortisol. In addition, psychometric instruments will evaluate changes in depression, anxiety, stress, sleep quality, and overall quality of life. The primary objective is to determine whether a short-term mindfulness body scan practice can effectively reduce systemic inflammation and improve post-disaster psychological well-being in coastal communities.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background: Recurrent tidal flooding in coastal Sayung, Demak, exposes residents to chronic environmental and socioeconomic stress, contributing to psychological distress and elevated systemic inflammation. Within a psychoneuroimmunological framework, mindfulness practices-specifically the body scan technique-may suppress pro-inflammatory pathways and regulate the hypothalamic-pituitary-adrenal (HPA) axis.
Study Design: This is a randomized controlled trial conducted at Sayung 1 Primary Health Center, Demak. Eligible adult survivors of tidal flooding will be randomly allocated to either the intervention group or the control group.
Intervention & Control:
- Intervention Group: Receives structured 8-day Mindfulness Body Scan training.
- Control Group: Receives standard health monitoring.
Assessments: Baseline and 1-week post-intervention evaluations will be conducted for all participants:
- Biomarkers: Venous blood samples to analyze Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), C-Reactive Protein (CRP), and Cortisol.
- Psychometric Assessments: Standardized questionnaires evaluating depression, anxiety, stress, sleep quality, and quality of life.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Natalia Dewi Wardani Dr. dr. Sp.KJ(K)
- Número de telefone: +6281325683134
- E-mail: anatdew@gmail.com
Locais de estudo
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Central Java
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Demak, Central Java, Indonésia
- Puskesmas Sayung 1
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 18 years or older.
- Resident of Sayung District, Demak Regency, affected by tidal flooding (rob).
- Registered patient at Sayung 1 Primary Health Center.
- Capable of providing written informed consent and participating in the intervention sessions.
Exclusion Criteria:
- Severe cognitive impairment, active psychosis, or severe psychiatric conditions preventing participation.
- Uncontrolled systemic autoimmune or inflammatory diseases.
- Current use of long-term systemic corticosteroid or immunosuppressive therapy.
- Inability to complete questionnaires or follow basic mindfulness instructions.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Mindfulness Body Scan
Participants undergo structured Mindfulness Body Scan training over an 8-day period alongside standard care
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A structured 8-day mind-body exercise where participants systematically direct non-judgmental attention to physical sensations throughout the body from head to toe
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Sem intervenção: Control Group
Participants receive standard health monitoring without the mindfulness body scan intervention
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Serum Interleukin-6 (IL-6) Levels
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Measured from venous blood samples using ELISA to evaluate changes in pro-inflammatory cytokine levels (concentrations reported in pg/mL).
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Baseline (Day 0) and post-intervention (Day 8)
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Change in Serum Tumor Necrosis Factor-alpha (TNF-α) Levels
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Measured from venous blood samples using ELISA to assess systemic inflammatory responses (concentrations reported in pg/mL)
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Baseline (Day 0) and post-intervention (Day 8)
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Change in Serum C-Reactive Protein (CRP) Levels
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Evaluated via laboratory blood analysis as an indicator of acute phase systemic inflammation (concentrations reported in mg/L).
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Baseline (Day 0) and post-intervention (Day 8)
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Change in Serum Cortisol Levels
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Measured via venous blood samples to assess HPA axis regulation and physiological stress response (concentrations reported in micro-g/dL).
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Baseline (Day 0) and post-intervention (Day 8)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Depression Score
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Measured using the Patient Health Questionnaire-9 (PHQ-9).
Scores range from 0 to 27, where higher scores indicate greater severity of depression.
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Baseline (Day 0) and post-intervention (Day 8)
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Change in Anxiety Score
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Measured using the Generalized Anxiety Disorder 7-item scale (GAD-7).
Scores range from 0 to 21, where higher scores indicate greater severity of anxiety.
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Baseline (Day 0) and post-intervention (Day 8)
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Change in Stress Score
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Measured using the Perceived Stress Scale (PSS-10).
Scores range from 0 to 40, where higher scores indicate higher levels of perceived stress.
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Baseline (Day 0) and post-intervention (Day 8)
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Change in Sleep Quality Score
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Measured using the Pittsburgh Sleep Quality Index (PSQI).
Global scores range from 0 to 21, where higher scores indicate worse sleep quality.
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Baseline (Day 0) and post-intervention (Day 8)
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Change in Quality of Life Score
Prazo: Baseline (Day 0) and post-intervention (Day 8)
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Measured using the 36-Item Short Form Health Survey (SF-36) Physical Component Summary.
Scores range from 0 to 100, where higher scores represent better health-related quality of life.
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Baseline (Day 0) and post-intervention (Day 8)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
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Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
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Outros números de identificação do estudo
- FK-UNDIP-MIND-01
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