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Completed

NCT Number: NCT04112121

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

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.

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Key information

Conditions

Hospitalism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Somogy Megyei Kaposi Mór Teaching Hospital

Kaposvár, 7400, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meeting with a Chaplain coupled with Biblical Readings

Behavioral

Primary outcomes

  1. Change in lymphocyte count

    Time frame: 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

    Time frame: Change from baseline at 120 minutes

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

  3. Change in interferon-gamma level

    Time frame: Change from baseline at 120 minutes

    enzyme-linked immunosorbent assay

  4. Change in immunoglobulin M level

    Time frame: Change from baseline at 120 minutes

    enzyme-linked immunosorbent assay

  5. Change in immunoglobulin A level

    Time frame: Change from baseline at 120 minutes

    enzyme-linked immunosorbent assay

  6. Change in immunoglobulin G level

    Time frame: Change from baseline at 120 minutes

    enzyme-linked immunosorbent assay

  7. Change in complement C3 level

    Time frame: Change from baseline at 120 minutes

    enzyme-linked immunosorbent assay

  8. Change in functional Magnetic Resonance Imaging activity

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Other

Registry information

Official study 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

Acronym: HEALING

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 2, 2019
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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