About this trial
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:
1. Intervention Group: Receives structured 8-day Mindfulness Body Scan training. 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Mindfulness Body Scan Training
BehavioralA structured 8-day mind-body exercise where participants systematically direct non-judgmental attention to physical sensations throughout the body from head to toe
Treatment groups
Trial outcomes
Primary outcomes
Change in Serum Interleukin-6 (IL-6) Levels
Measured from venous blood samples using ELISA to evaluate changes in pro-inflammatory cytokine levels (concentrations reported in pg/mL).
Change in Serum Tumor Necrosis Factor-alpha (TNF-α) Levels
Measured from venous blood samples using ELISA to assess systemic inflammatory responses (concentrations reported in pg/mL)
Change in Serum C-Reactive Protein (CRP) Levels
Evaluated via laboratory blood analysis as an indicator of acute phase systemic inflammation (concentrations reported in mg/L).
Change in Serum Cortisol Levels
Measured via venous blood samples to assess HPA axis regulation and physiological stress response (concentrations reported in micro-g/dL).
Secondary outcomes
Change in Depression Score
Measured using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, where higher scores indicate greater severity of depression.
Change in Anxiety Score
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.
Change in Stress Score
Measured using the Perceived Stress Scale (PSS-10). Scores range from 0 to 40, where higher scores indicate higher levels of perceived stress.
Change in Sleep Quality Score
Measured using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, where higher scores indicate worse sleep quality.
Sponsors and contacts
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Natalia Dewi Wardani, MD
Lead sponsor
Universitas Diponegoro
Sponsor institution
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