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The Effect of Mindfulness in Inflammation Markers (IL-6, TNF-A, CRP and Cortisol) Among Survivors of Tidal Flooding in Sayung Demak

2026年8月27日 更新者：Natalia Dewi Wardani, MD

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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:

  1. Biomarkers: Venous blood samples to analyze Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), C-Reactive Protein (CRP), and Cortisol.
  2. Psychometric Assessments: Standardized questionnaires evaluating depression, anxiety, stress, sleep quality, and quality of life.

研究类型

介入性

注册 (估计的)

75

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Natalia Dewi Wardani Dr. dr. Sp.KJ(K)
  • 电话号码：+6281325683134
  • 邮箱：anatdew@gmail.com

学习地点

  • 印度尼西亚
    • Central Java
      • Demak、Central Java、印度尼西亚
        • Puskesmas Sayung 1

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Mindfulness Body Scan
Participants undergo structured Mindfulness Body Scan training over an 8-day period alongside standard care
行为的：Mindfulness Body Scan Training
A structured 8-day mind-body exercise where participants systematically direct non-judgmental attention to physical sensations throughout the body from head to toe
无干预：Control Group
Participants receive standard health monitoring without the mindfulness body scan intervention

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Serum Interleukin-6 (IL-6) Levels
大体时间：Baseline (Day 0) and post-intervention (Day 8)
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
大体时间：Baseline (Day 0) and post-intervention (Day 8)
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
大体时间：Baseline (Day 0) and post-intervention (Day 8)
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)
Change in Serum Cortisol Levels
大体时间：Baseline (Day 0) and post-intervention (Day 8)
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)

次要结果测量

结果测量
措施说明
大体时间
Change in Depression Score
大体时间：Baseline (Day 0) and post-intervention (Day 8)
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)
Change in Anxiety Score
大体时间：Baseline (Day 0) and post-intervention (Day 8)
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.
Baseline (Day 0) and post-intervention (Day 8)
Change in Stress Score
大体时间：Baseline (Day 0) and post-intervention (Day 8)
Measured using the Perceived Stress Scale (PSS-10). Scores range from 0 to 40, where higher scores indicate higher levels of perceived stress.
Baseline (Day 0) and post-intervention (Day 8)
Change in Sleep Quality Score
大体时间：Baseline (Day 0) and post-intervention (Day 8)
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)
Change in Quality of Life Score
大体时间：Baseline (Day 0) and post-intervention (Day 8)
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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Natalia Dewi Wardani, MD

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年8月24日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年9月1日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FK-UNDIP-MIND-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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