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NCT07790055Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
75 (estimated)
First submitted
24 Aug 2026
Start date
1 Sept 2026
Primary completion date
1 Feb 2027
Lead sponsor
Natalia Dewi Wardani, MD
Diseases
Depression
NCT number
NCT07790055

What you commit to

  • Study type: Interventional
  • Planned participants: 75
  • From 1 Sept 2026 to the primary completion date, 1 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current use of long-term systemic corticosteroid or immunosuppressive therapy.

Other illness

  • Severe cognitive impairment, active psychosis, or severe psychiatric conditions preventing participation.
  • Uncontrolled systemic autoimmune or inflammatory diseases.

Other

  • Inability to complete questionnaires or follow basic mindfulness instructions.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Puskesmas Sayung 1
Coordinator of this site? Confirm its status
DemakIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.