Hospital-based Ecumenical And Linguistical, Immuno- Neuro-Genetic (HEALING) Study - Randomized Clinical Trial - A Study on the Epigenetic Background of Neuro-immune-modulation in Clinical Environment

Somogy Megyei Kaposi Mór Teaching Hospital1 个研究点分布在 1 个国家目标入组 57 人开始时间: 2015年9月10日最近更新: 2019年10月15日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 57
试验地点: 1
主要终点: Change in immunoglobulin M level

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of the "HEALING" " (Hospital-based Ecumenical And Linguistic Immuno-NeuroloGic) Study was to examine immunological and neurological changes in hospitalized participants after meeting a chaplain and Biblical listenings, in order to evaluate whether these meetings affect the course of the disease.

详细描述

The authors pre-screened hospitalized participants to find those who were the most in need of an intervention by a chaplain. A passage from the Bible was read to the participants during a meeting with the chaplain at the bedside, or in the chapel of the hospital. No meeting occurred in the randomized control group, which was compiled in a way to get a group of participants with an approximatively similar pattern of diagnoses and treatment days than the intervention groups. The pace of enrollment was deliberately slow in order to assure the authenticity of the visits ("slow science"). Blood samples were taken 30 minutes prior, and 60 minutes after the meeting to measure White Blood Cell (WBC)-, lymphocyte counts, interferon gamma (IFN-γ)-, immunoglobulin M (IgM)-, immunoglobulin A (IgA)-, immunoglobulin G (IgG)-, and complement C3 levels. A subgroup of the visited participants was subjected to functional Magnetic Resonance Imaging (fMRI), where they were played an audiotape of readings of the same passage from the Bible. Associative tests, paired-samples t-test, network analysis was performed to search for any correlation between psychological and immunological parameters, completed with Statistical Parametric Mapping to search for correlations of the above with neurological parameters.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•adult age (>18 years)
•the condition of being hospitalized
•the ability for verbal communication
•alertness, orientation
•no sign of psychosis in their medical history
•willingness to participate in the study after written, informed consent

排除标准

•the inability to communicate verbally
•psychotic state, altered mental state
•unwillingness to participate
•active and treated malignant disease
•steroid, NSAID or metamizole- sodium use

研究组 & 干预措施

Patients Meeting the Chaplain at the Bedside

Experimental

First meeting with the chaplain, coupled with biblical readings at the bedside.

干预措施: Meeting with a Chaplain coupled with Biblical Readings (Behavioral)

Patients Meeting the Chaplain at the Chapel

Experimental

First meeting with the chaplain, coupled with biblical readings at the hospital's chapel

干预措施: Meeting with a Chaplain coupled with Biblical Readings (Behavioral)

Patients Not Meeting the Chaplain

No Intervention

In the control group we enrolled patients whose diagnoses and number of days in the hospital was similar to the intervention groups (covariate-adaptive, blocked, stratified randomization method).