Puskesmas Sayung 1
Demak, Central Java, Indonesia
NCT Number: NCT07796919
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.
This 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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Demak, Central Java, Indonesia
Background:
Coastal 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.
Study Design and Objectives:
This 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.
Intervention:
Participants 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.
Assessments:
Data Analysis:
Pre- 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline and Day 8 (post-intervention)
Changes in MLR derived from routine complete blood count to evaluate systemic inflammation.
Time frame: Baseline and Day 8 (post-intervention)
Changes in NLR derived from routine complete blood count to evaluate systemic inflammation
Time frame: Baseline and Day 8 (post-intervention)
Changes in PLR derived from routine complete blood count to evaluate systemic inflammation.
Time frame: Baseline and Day 8 (post-intervention)
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.
Time frame: Baseline and Day 8 (post-intervention)
Evaluation of changes in depressive symptoms using the BDI questionnaire. Total score ranges from 0 to 63, where higher scores indicate more severe depression.
Time frame: Baseline and Day 8 (post-intervention)
Evaluation of depression severity using the PHQ-9 scale. Total score ranges from 0 to 27, where higher scores indicate more severe depressive symptoms.
Time frame: Baseline and Day 8 (post-intervention)
Evaluation of sleep quality using the PSQI questionnaire. Total score ranges from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame: Baseline and Day 8 (post-intervention)
Evaluation of psychological resilience levels using the CD-RISC questionnaire. Total score ranges from 0 to 100, where higher scores indicate greater resilience.
Time frame: Baseline and Day 8 (post-intervention)
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.
Time frame: Baseline and Day 8 (post-intervention)
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.
Contact information is provided by the study sponsor or research team.
Natalia Dewi Wardani, MD
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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