Clinical trial NCT04112121: Psychological, Neurological and Immunological Changes Following a Meeting With a Chaplain Coupled With Biblical Readings
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalism
Keywords: faith
religion
hospitalization
immunology
psychoneuroimmunology
theology
fMRI
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel, randomized, open-labeled, controlled clinical trial
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in lymphocyte count
timeFrame: Change from baseline at 120 minutes
measure: Change in total white blood cell (WBC) count
timeFrame: Change from baseline at 120 minutes
measure: Change in interferon-gamma level
timeFrame: Change from baseline at 120 minutes
measure: Change in immunoglobulin M level
timeFrame: Change from baseline at 120 minutes
measure: Change in immunoglobulin A level
timeFrame: Change from baseline at 120 minutes
measure: Change in immunoglobulin G level
timeFrame: Change from baseline at 120 minutes
measure: Change in complement C3 level
timeFrame: Change from baseline at 120 minutes
measure: Change in functional Magnetic Resonance Imaging activity
timeFrame: Change from baseline during the 60 second long activation block
measure: Participants' satisfaction with the visit as assessed by Scores given on the "Healing - after" Questionnaire
timeFrame: within 1 hour after intervention
measure: Chaplain's satisfaction with the visit as assessed by Scores given on the "Healing - after" Questionnaire
timeFrame: within 1 hour after intervention
measure: Participants' level of distress in the month preceding the measurement as assessed with the total Score of the Perceived Stress Scale 14 (PSS-14)
timeFrame: within 30 minutes before intervention
measure: 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
timeFrame: within 30 minutes before intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Teaching Hospital
Study officials:
affiliation: Physician
name: András Béres, M.D.
role: PRINCIPAL_INVESTIGATOR
References: