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

NCT04112121 | Completed

• 1 other identifier: HEALING STUDY IG/3355/2013
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospitalism

Keywords

faith; religion; hospitalization; immunology; psychoneuroimmunology; theology; fMRI

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (3)

Patients Meeting the Chaplain at the Bedside

EXPERIMENTAL

First meeting with the chaplain, coupled with biblical readings at the bedside.

Behavioral: Meeting with a Chaplain coupled with Biblical Readings

Patients Meeting the Chaplain at the Chapel

EXPERIMENTAL

First meeting with the chaplain, coupled with biblical readings at the hospital's chapel

Behavioral: Meeting with a Chaplain coupled with Biblical Readings

Patients Not Meeting the Chaplain

NO INTERVENTION

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).

Interventions

Meeting with a Chaplain coupled with Biblical Readings BEHAVIORAL

Patients Meeting the Chaplain at the Bedside; Patients Meeting the Chaplain at the Chapel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• the inability to communicate verbally
• psychotic state, altered mental state
• unwillingness to participate
• active and treated malignant disease
• steroid, NSAID or metamizole- sodium use

Sponsors & Collaborators

• Somogy Megyei Kaposi Mór Teaching Hospital: lead

Study Sites (1)

Somogy Megyei Kaposi Mór Teaching Hospital

Kaposvár, 7400, Hungary

Location

Related Publications (1)

• Beres A, Emri M, Aranyi C, Fajtai D, Nagy F, Szabo P, Bodecs P, Horcsik E, Perpekne Papp E, Tomanek F, Kuti M, Petofalvine A, Kisdeakne H, Biro G, Kovacs D, Bakos B, Vinczen E, Gal E, Sillinger R, Szalai Z, Szilagyi A, Kiss-Merki M, Nagyeri G, Fodor J, Nemeth T, Papp E, Repa I. Healing through faith: Meeting a chaplain coupled with biblical readings could produce lymphocyte changes that correlate with brain activity (HEALING study). F1000Res. 2024 Oct 30;10:1295. doi: 10.12688/f1000research.74504.5. eCollection 2021.

  PMID: 40496603 DERIVED

Study Officials

• András Béres, M.D.

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: parallel, randomized, open-labeled, controlled clinical trial

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 2, 2019
• Study Start: September 10, 2015
• Primary Completion: January 2, 2017
• Study Completion: January 2, 2017
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

HU (1)