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

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

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.

Study Overview

• Status: Completed
• Conditions: Hospitalism
• Intervention / Treatment: Behavioral: Meeting with a Chaplain coupled with Biblical Readings

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Kaposvár, Hungary, 7400
    • Somogy Megyei Kaposi Mór Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
• Investigators: Principal Investigator: András Béres, M.D., Physician

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2015
• Primary Completion (Actual): January 2, 2017
• Study Completion (Actual): January 2, 2017

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: fMRI; hospitalization; immunology; religion; psychoneuroimmunology; faith; theology
• Other Study ID Numbers: HEALING STUDY IG/3355/2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No