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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Natalia Dewi Wardani Dr. dr. Sp.KJ(K)
- 電話番号：+6281325683134
- メール：anatdew@gmail.com
研究場所
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Central Java
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Demak、Central Java、インドネシア
- Puskesmas Sayung 1
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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介入なし：Control Group
Participants receive standard health monitoring without the mindfulness body scan intervention
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Serum Interleukin-6 (IL-6) Levels
時間枠：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
時間枠：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
時間枠：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).
|
Baseline (Day 0) and post-intervention (Day 8)
|
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Change in Serum Cortisol Levels
時間枠：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).
|
Baseline (Day 0) and post-intervention (Day 8)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Depression Score
時間枠：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.
|
Baseline (Day 0) and post-intervention (Day 8)
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Change in Anxiety Score
時間枠：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
時間枠：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
時間枠：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.
|
Baseline (Day 0) and post-intervention (Day 8)
|
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Change in Quality of Life Score
時間枠：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.
|
Baseline (Day 0) and post-intervention (Day 8)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- FK-UNDIP-MIND-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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