Psychological, Neurological and Immunological Changes Following a Meeting With a Chaplain Coupled With Biblical Readings

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hospitalism

Intervention / Treatment
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* Behavioral: Meeting with a Chaplain coupled with Biblical Readings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: the inability to communicate verbally psychotic state, altered mental state unwillingness to participate active and treated malignant disease steroid, NSAID or metamizole- sodium use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel, randomized, open-labeled, controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients Meeting the Chaplain at the Bedside<br>First meeting with the chaplain, coupled with biblical readings at the bedside. | Behavioral: Meeting with a Chaplain coupled with Biblical Readings<br> <br> |
| Experimental: Patients Meeting the Chaplain at the Chapel<br>First meeting with the chaplain, coupled with biblical readings at the hospital's chapel | Behavioral: Meeting with a Chaplain coupled with Biblical Readings<br> <br> |
| No Intervention: Patients Not Meeting the Chaplain<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lymphocyte count | lymphocyte count measured with automatised laboratory measurement and microscopic blood smear examination | Change from baseline at 120 minutes | 
| Change in total white blood cell (WBC) count | WBC count measured with automatised laboratory measurement and microscopic blood smear examination | Change from baseline at 120 minutes | 
| Change in interferon-gamma level | enzyme-linked immunosorbent assay | Change from baseline at 120 minutes | 
| Change in immunoglobulin M level | enzyme-linked immunosorbent assay | Change from baseline at 120 minutes | 
| Change in immunoglobulin A level | enzyme-linked immunosorbent assay | Change from baseline at 120 minutes | 
| Change in immunoglobulin G level | enzyme-linked immunosorbent assay | Change from baseline at 120 minutes | 
| Change in complement C3 level | enzyme-linked immunosorbent assay | Change from baseline at 120 minutes | 
| Change in functional Magnetic Resonance Imaging activity | Statistical Parametric Mapping analysis of Blood Oxygenation Level Dependent (BOLD) answers | Change from baseline during the 60 second long activation block | 
| Participants' satisfaction with the visit as assessed by Scores given on the Healing - after Questionnaire | Participants' assessement of their satisfaction on single-item rating scales in a Questionnaire designed for the Study. Answers range from 1 to 5, with higher values representing better outcomes. | within 1 hour after intervention | 
| Chaplain's satisfaction with the visit as assessed by Scores given on the Healing - after Questionnaire | Chaplain's assessement of her satisfaction on single-item rating scales in a Questionnaire designed for the Study. Answers range from 1 to 5, with higher values representing better outcomes. | within 1 hour after intervention | 
| Participants' level of distress in the month preceding the measurement as assessed with the total Score of the Perceived Stress Scale 14 (PSS-14) | PSS-14 Scale uses 14 questions with answers ranging from 0 to 4, with higher values indicating higher levels of distress on the seven negative-, and lower levels of distress on the seven positive items. Scores are obtained by reversing the scores on the seven positive items, then summing across all to give the total PSS-14 Score. | within 30 minutes before intervention | 
| Participants' spiritual and psychological needs, religious practice, thoughts about how they became sick, and how they could heal, as assessed by Scores given on the Healing - before Questionnaire | Participants' assessement on single-item rating scales in a Questionnaire designed for the Study (Healing - before Questionnaire). Answers range from 1 to 5, with higher values representing better outcomes. | within 30 minutes before intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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faith, religion, hospitalization, immunology, psychoneuroimmunology, theology, fMRI