The Effect of Mindfulness in Inflammation Markers (MLR, NLR, PLR), Stress, Anxiety, and Depression Rate Among Survivors of Tidal Flooding in Sayung Demak
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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:
- Laboratory Testing: Complete blood counts to determine monocyte, neutrophil, platelet, and lymphocyte ratios (MLR, NLR, PLR) pre- and post-intervention.
Psychometric Evaluations: Assessment of psychological symptoms using validated tools, including:
- Beck Depression Inventory (BDI) & Patient Health Questionnaire-9 (PHQ-9)
- Depression, Anxiety, and Stress Scale-21 (DASS-21)
- Impact of Event Scale - Revised (IES-R) & PTSD Checklist-5 (PCL-5)
- Pittsburgh Sleep Quality Index (PSQI)
- Connor-Davidson Resilience Scale (CD-RISC)
- Spiritual Wellbeing Scale (SWBS)
- Fatigue Assessment Scale (FAS)
- WHO Quality of Life (WHOQOL)
- Perceived Social Performance (PSP)
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Natalia Dewi Wardani Dr. dr. Sp.KJ(K)
- 전화번호: +6281325683134
- 이메일: anatdew@gmail.com
연구 장소
-
-
Central Java
-
Demak, Central Java, 인도네시아
- Puskesmas Sayung 1
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 to 60 years.
- Survivors of tidal flooding (bencana rob) residing in the Sayung coastal area for at least 6 months.
- Minimum educational attainment of Primary School (Sekolah Dasar / SD).
- Literate in Indonesian (able to read and write).
- Willing to participate in and complete the 8-day mindfulness intervention program.
- Physically independent and capable of completing self-administered questionnaires.
Exclusion Criteria:
- Active psychotic disorders or severe mental illness.
- Cognitive impairment that limits ability to complete assessments.
- History of diagnosed autoimmune disorders, active allergies, or chronic inflammatory diseases.
- Presence of acute infectious disease symptoms within the past 1 month.
- Currently undergoing formal psychotherapy or other structured psychological interventions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Mindfulness Body Scan Group
Participants in this single arm receive an 8-day community-based mindfulness body scan training designed to evaluate its effects on systemic inflammatory markers (MLR, NLR, PLR) and psychological parameters.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Monocyte-to-Lymphocyte Ratio (MLR)
기간: Baseline and Day 8 (post-intervention)
|
Changes in MLR derived from routine complete blood count to evaluate systemic inflammation.
|
Baseline and Day 8 (post-intervention)
|
|
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
기간: Baseline and Day 8 (post-intervention)
|
Changes in NLR derived from routine complete blood count to evaluate systemic inflammation
|
Baseline and Day 8 (post-intervention)
|
|
Change in Platelet-to-Lymphocyte Ratio (PLR)
기간: Baseline and Day 8 (post-intervention)
|
Changes in PLR derived from routine complete blood count to evaluate systemic inflammation.
|
Baseline and Day 8 (post-intervention)
|
|
Change in DASS-21 Score
기간: 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.
|
Baseline and Day 8 (post-intervention)
|
|
Change in Beck Depression Inventory (BDI) Score
기간: 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.
|
Baseline and Day 8 (post-intervention)
|
|
Change in Patient Health Questionnaire-9 (PHQ-9) Score
기간: 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.
|
Baseline and Day 8 (post-intervention)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) Score
기간: 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.
|
Baseline and Day 8 (post-intervention)
|
|
Change in Connor-Davidson Resilience Scale (CD-RISC) Score
기간: 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.
|
Baseline and Day 8 (post-intervention)
|
|
Change in Impact of Event Scale-Revised (IES-R) Score
기간: 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.
|
Baseline and Day 8 (post-intervention)
|
|
Change in WHOQOL-BREF Score
기간: 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.
|
Baseline and Day 8 (post-intervention)
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Kabat-Zinn J. Full catastrophe living: using the wisdom of your body and mind to face stress, pain, and illness. New York: Dell Publishing; 2013.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- FK-UNDIP-MIND-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .