AzTrials
AzTrials

HospitalismHEALINGNCT04112121

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

A study testing Meeting with a Chaplain coupled with Biblical Readings in people with Hospitalism, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hospitalism
What is being tested?
Meeting with a Chaplain coupled with Biblical Readings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteHungary
Study dates
10 Sep 2015to 2 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Somogy Megyei Kaposi Mór Teaching Hospital

    Kaposvár, 7400

Other trials in Hungary

About this study

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

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.

Read the 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.

Conditions
Hospitalism
Being tested
Meeting with a Chaplain coupled with Biblical Readings
Keywords
faith, religion, hospitalization, immunology, psychoneuroimmunology, theology, fMRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meeting with a Chaplain coupled with Biblical ReadingsBehavioural

Study groups in NCT04112121
Study groupRoleWhat they receive
Patients Meeting the Chaplain at the BedsideExperimentalFirst meeting with the chaplain, coupled with biblical readings at the bedside.
Receives: Behavioral: Meeting with a Chaplain coupled with Biblical Readings
Patients Meeting the Chaplain at the ChapelExperimentalFirst meeting with the chaplain, coupled with biblical readings at the hospital's chapel
Receives: Behavioral: Meeting with a Chaplain coupled with Biblical Readings
Patients Not Meeting the ChaplainNo interventionIn 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in lymphocyte count

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

    Measured: Change from baseline at 120 minutes

  2. Change in total white blood cell (WBC) count

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

    Measured: Change from baseline at 120 minutes

  3. Change in interferon-gamma level

    enzyme-linked immunosorbent assay

    Measured: Change from baseline at 120 minutes

  4. Change in immunoglobulin M level

    enzyme-linked immunosorbent assay

    Measured: Change from baseline at 120 minutes

  5. Change in immunoglobulin A level

    enzyme-linked immunosorbent assay

    Measured: Change from baseline at 120 minutes

  6. Change in immunoglobulin G level

    enzyme-linked immunosorbent assay

    Measured: Change from baseline at 120 minutes

  7. Change in complement C3 level

    enzyme-linked immunosorbent assay

    Measured: Change from baseline at 120 minutes

  8. Change in functional Magnetic Resonance Imaging activity

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

    Measured: Change from baseline during the 60 second long activation block

  9. 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.

    Measured: within 1 hour after intervention

  10. 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.

    Measured: within 1 hour after intervention

  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)

    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.

    Measured: within 30 minutes before intervention

  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

    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.

    Measured: within 30 minutes before intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2019
  2. Study start10 Sep 2015
  3. Primary completion2 Jan 2017
  4. Study completion2 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel, randomized, open-labeled, controlled clinical trial
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04112121
Sponsor's protocol ID
HEALING STUDY IG/3355/2013
Acronym
HEALING
Status last verified
Oct 2019
First submitted
29 Sep 2019
Last updated
15 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40496603

Questions about this trial

What is this clinical trial studying?

A study testing Meeting with a Chaplain coupled with Biblical Readings in people with Hospitalism, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lymphocyte count (time frame: Change from baseline at 120 minutes). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04112121, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in