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

• Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04112121
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 3
• Actual Duration (Months): 15.8
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hospitalism	Behavioral: Meeting with a Chaplain coupled with Biblical Readings	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel, randomized, open-labeled, controlled clinical trialparallel, randomized, open-labeled, controlled clinical trial
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Sep 10, 2015
• Actual Primary Completion Date: Jan 2, 2017
• Actual Study Completion Date: Jan 2, 2017

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Change in lymphocyte count [Change from baseline at 120 minutes]

   lymphocyte count measured with automatised laboratory measurement and microscopic blood smear examination

2. Change in total white blood cell (WBC) count [Change from baseline at 120 minutes]

   WBC count measured with automatised laboratory measurement and microscopic blood smear examination

3. Change in interferon-gamma level [Change from baseline at 120 minutes]

   enzyme-linked immunosorbent assay

4. Change in immunoglobulin M level [Change from baseline at 120 minutes]

   enzyme-linked immunosorbent assay

5. Change in immunoglobulin A level [Change from baseline at 120 minutes]

   enzyme-linked immunosorbent assay

6. Change in immunoglobulin G level [Change from baseline at 120 minutes]

   enzyme-linked immunosorbent assay

7. Change in complement C3 level [Change from baseline at 120 minutes]

   enzyme-linked immunosorbent assay

8. Change in functional Magnetic Resonance Imaging activity [Change from baseline during the 60 second long activation block]

   Statistical Parametric Mapping analysis of Blood Oxygenation Level Dependent (BOLD) answers

9. Participants' satisfaction with the visit as assessed by Scores given on the "Healing - after" Questionnaire [within 1 hour after intervention]

   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.

10. Chaplain's satisfaction with the visit as assessed by Scores given on the "Healing - after" Questionnaire [within 1 hour after intervention]

    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.

11. Participants' level of distress in the month preceding the measurement as assessed with the total Score of the Perceived Stress Scale 14 (PSS-14) [within 30 minutes before intervention]

    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.

12. 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 [within 30 minutes before intervention]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Somogy Megyei Kaposi Mór Teaching Hospital	Kaposvár		Hungary	7400

Sponsors and Collaborators

• Somogy Megyei Kaposi Mór Teaching Hospital

Investigators

• Principal Investigator: András Béres, M.D., Physician

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. András Béres, Principal Investigator, Somogy Megyei Kaposi Mór Teaching Hospital
• ClinicalTrials.gov Identifier: NCT04112121
• Other Study ID Numbers: HEALING STUDY IG/3355/2013
• First Posted: Oct 2, 2019
• Last Update Posted: Oct 15, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. András Béres, Principal Investigator, Somogy Megyei Kaposi Mór Teaching Hospital: faith; religion; hospitalization; immunology; psychoneuroimmunology; theology; fMRI

Study Results

No Results Posted as of Oct 15, 2019