The COVID-19 ICU PRAYER Study

NCT ID: NCT04361838

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2021-04-30

Brief Summary

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This is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.

Detailed Description

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Conditions

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Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Prayer

Patients will receive a daily prayer and standard of care treatment from multi-denominational group while in the ICU.

Group Type ACTIVE_COMPARATOR

prayer

Intervention Type BEHAVIORAL

receive prayers daily while in ICU

No Prayer

Patients will receive standard of care treatment while in the ICU.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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prayer

receive prayers daily while in ICU

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male or female greater than 18 years of age
* Confirmed positive for COVID-19
* Patient admitted to Intensive Care Unit

Exclusion Criteria

* Patients admitted to ICU for diagnosis that is not COVID-19 positive.
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kansas City Heart Rhythm Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dhanunjaya Lakkireddy, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City Heart Rhythm Institute

Locations

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Research Medical Center

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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Koenig HG, Cohen HJ, Blazer DG, Pieper C, Meador KG, Shelp F, Goli V, DiPasquale B. Religious coping and depression among elderly, hospitalized medically ill men. Am J Psychiatry. 1992 Dec;149(12):1693-700. doi: 10.1176/ajp.149.12.1693.

Reference Type BACKGROUND
PMID: 1443246 (View on PubMed)

Koenig HG, George LK, Hays JC, Larson DB, Cohen HJ, Blazer DG. The relationship between religious activities and blood pressure in older adults. Int J Psychiatry Med. 1998;28(2):189-213. doi: 10.2190/75JM-J234-5JKN-4DQD.

Reference Type BACKGROUND
PMID: 9724889 (View on PubMed)

Currier JM, Foster JD, Witvliet CV, Abernethy AD, Root Luna LM, Schnitker SA, VanHarn K, Carter J. Spiritual struggles and mental health outcomes in a spiritually integrated inpatient program. J Affect Disord. 2019 Apr 15;249:127-135. doi: 10.1016/j.jad.2019.02.012. Epub 2019 Feb 6.

Reference Type BACKGROUND
PMID: 30772739 (View on PubMed)

Naimi E, Eilami O, Babuei A, Rezaei K, Moslemirad M. The Effect of Religious Intervention Using Prayer for Quality of Life and Psychological Status of Patients with Permanent Pacemaker. J Relig Health. 2020 Apr;59(2):920-927. doi: 10.1007/s10943-018-0698-8.

Reference Type BACKGROUND
PMID: 30218372 (View on PubMed)

Byrd RC. Positive therapeutic effects of intercessory prayer in a coronary care unit population. South Med J. 1988 Jul;81(7):826-9. doi: 10.1097/00007611-198807000-00005.

Reference Type BACKGROUND
PMID: 3393937 (View on PubMed)

Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, Forker A, O'Keefe JH, McCallister BD. A randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Arch Intern Med. 1999 Oct 25;159(19):2273-8. doi: 10.1001/archinte.159.19.2273.

Reference Type BACKGROUND
PMID: 10547166 (View on PubMed)

Lakkireddy D, Vacek J, Harris W, Gowda M, Pendyala K, Murray C. Modified Mid America Heart Institute Coronary Care Unit scoring system--a new comprehensive prognostic index for Coronary Care Unit patients. Med Sci Monit. 2005 Mar;11(3):CR95-9.

Reference Type BACKGROUND
PMID: 15735569 (View on PubMed)

Jentzer JC, Bennett C, Wiley BM, Murphree DH, Keegan MT, Gajic O, Wright RS, Barsness GW. Predictive Value of the Sequential Organ Failure Assessment Score for Mortality in a Contemporary Cardiac Intensive Care Unit Population. J Am Heart Assoc. 2018 Mar 10;7(6):e008169. doi: 10.1161/JAHA.117.008169.

Reference Type BACKGROUND
PMID: 29525785 (View on PubMed)

Yoon JC, Kim YJ, Lee YJ, Ryoo SM, Sohn CH, Seo DW, Lee YS, Lee JH, Lim KS, Kim WY. Serial evaluation of SOFA and APACHE II scores to predict neurologic outcomes of out-of-hospital cardiac arrest survivors with targeted temperature management. PLoS One. 2018 Apr 5;13(4):e0195628. doi: 10.1371/journal.pone.0195628. eCollection 2018.

Reference Type BACKGROUND
PMID: 29621337 (View on PubMed)

Yang Y, Peng F, Wang R, Yange M, Guan K, Jiang T, Xu G, Sun J, Chang C. The deadly coronaviruses: The 2003 SARS pandemic and the 2020 novel coronavirus epidemic in China. J Autoimmun. 2020 May;109:102434. doi: 10.1016/j.jaut.2020.102434. Epub 2020 Mar 3.

Reference Type BACKGROUND
PMID: 32143990 (View on PubMed)

Other Identifiers

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Covid Prayer Study

Identifier Type: -

Identifier Source: org_study_id

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