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

Hospitalism Clinical Trial

— HEALING  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112121
• Other study ID #: HEALING STUDY IG/3355/2013
• Status: Completed
• Phase: N/A
• Start date: September 10, 2015
• Est. completion date: January 2, 2017

Study information

• Verified date: October 2019
• Source: Somogy Megyei Kaposi Mór Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2, 2017
• Est. primary completion date: January 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hospitalism

Intervention

Behavioral:
• Meeting with a Chaplain coupled with Biblical Readings

Locations

Country	Name	City	State
Hungary	Somogy Megyei Kaposi Mór Teaching Hospital	Kaposvár

Sponsors (1)

Lead Sponsor	Collaborator
Somogy Megyei Kaposi Mór Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lymphocyte count	lymphocyte count measured with automatised laboratory measurement and microscopic blood smear examination	Change from baseline at 120 minutes
Primary	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
Primary	Change in interferon-gamma level	enzyme-linked immunosorbent assay	Change from baseline at 120 minutes
Primary	Change in immunoglobulin M level	enzyme-linked immunosorbent assay	Change from baseline at 120 minutes
Primary	Change in immunoglobulin A level	enzyme-linked immunosorbent assay	Change from baseline at 120 minutes
Primary	Change in immunoglobulin G level	enzyme-linked immunosorbent assay	Change from baseline at 120 minutes
Primary	Change in complement C3 level	enzyme-linked immunosorbent assay	Change from baseline at 120 minutes
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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