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Sponsor study identifier
interventional
75
1 country
1
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2026
Actual (reported)August 27, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Baseline (Day 0) and post-intervention (Day 8)
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)
Baseline (Day 0) and post-intervention (Day 8)
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).
Baseline (Day 0) and post-intervention (Day 8)
Participants undergo structured Mindfulness Body Scan training over an 8-day period alongside standard care
Participants receive standard health monitoring without the mindfulness body scan intervention
A structured 8-day mind-body exercise where participants systematically direct non-judgmental attention to physical sensations throughout the body from head to toe
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Puskesmas Sayung 1
Demak, Central Java, Indonesia
First Submitted
August 24, 2026
First Posted
August 27, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Baseline (Day 0) and post-intervention (Day 8)
Change in Depression Score
Baseline (Day 0) and post-intervention (Day 8)
Change in Anxiety Score
Baseline (Day 0) and post-intervention (Day 8)
Change in Stress Score
Baseline (Day 0) and post-intervention (Day 8)
Change in Sleep Quality Score
Baseline (Day 0) and post-intervention (Day 8)
Change in Quality of Life Score
Baseline (Day 0) and post-intervention (Day 8)
Contact the study team to confirm eligibility.
Primary Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 1, 2026
Record last verified: 2026-08
The data are not publicly available due to privacy or ethical restrictions. The dataset involves sensitive information about mental health, and sharing it publicly would compromise participant confidentiality as per the ethical approval obtained.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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