Study of the Therapeutic Effects of Intercessory Prayer (STEP)

Coronary Artery Bypass Grafting Surgery Clinical Trial

Official title:

Study of the Therapeutic Effects of Intercessory Prayer (STEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179491
• Other study ID #: 2001-P-002125
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 2, 2007
• Start date: April 1998
• Est. completion date: November 2001

Study information

• Verified date: November 2007
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.

Description:

Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1802
• Est. completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age 18 years or older

• Able to read or understand English

Exclusion criteria:

• Scheduled for emergent CABG (next available operating room slot)

• CABG more than 14 days after enrollment

• Other planned surgery within 30 days of CABG

• Minimally invasive CABG (non full sternotomy incisions)

• CABG with planned valve replacement, stent, angioplasty or carotid endarterectomy

• Or had ongoing chest pain or unstable angina, as defined by their physicians

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting Surgery

Intervention

Behavioral:
• Intercessory Prayer
14 days of intercessory prayer from 3 sites

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Baptist Memorial Health Care Corporation, INTEGRIS Baptist Medical Center, John Templeton Foundation, Mayo Clinic, Washington Hospital Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.		30 days
Secondary	Whether being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.		30 days