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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04112121
Other study ID # HEALING STUDY IG/3355/2013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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