Coronary Artery Bypass Grafting SurgeryPhase 3NCT00179491
Study of the Therapeutic Effects of Intercessory Prayer (STEP)
A Phase 3 study testing Intercessory Prayer in people with Coronary Artery Bypass Grafting Surgery, run by Beth Israel Deaconess Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting Surgery
- What is being tested?
- Intercessory Prayer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,802 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Nov 2001
- Phase
- Phase 3
- 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
- Age 18 years or older
- Able to read or understand English
Who cannot join
- 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
About this study
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.
Read the detailed 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.
- Conditions
- Coronary Artery Bypass Grafting Surgery
- Being tested
- Intercessory Prayer
- Keywords
- coronary artery bypass grafting surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercessory PrayerBehavioural
14 days of intercessory prayer from 3 sites
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 604 patients received intercessory prayer after being informed they may or may not receive prayers (Group 1) Receives: Behavioral: Intercessory Prayer |
| 2 | No intervention | 597 patients did not receive prayer after being informed they may or may not receive prayer (Group 2) |
| Group 3 | Experimental | 601 patients received intercessory prayer after being informed they would receive it (Group 3). Receives: Behavioral: Intercessory Prayer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.
Measured: 30 days
Secondary outcomes (1)
Whether being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 1998
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Grafting SurgeryStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- John Templeton Foundation, INTEGRIS Baptist Medical Center, Medstar Health Research Institute, Baptist Memorial Health Care Corporation, Mayo Clinic
- Investigators
- Herbert Benson, MD, Principal investigator, Beth Israel Deaconess Medical Center, Mind/Body Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179491
- Sponsor's protocol ID
- 2001-P-002125
- Status last verified
- Nov 2007
- First submitted
- 13 Sep 2005
- Last updated
- 5 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Therapeutic Effects of Intercessory Prayer (STEP)
- ClinicalTrials.gov ID
- NCT00179491
- Acronym / sponsor ID
- 2001-P-002125
- Conditions
- Coronary Artery Bypass Grafting Surgery
- Keywords
- coronary artery bypass grafting surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,802 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- John Templeton Foundation, INTEGRIS Baptist Medical Center, Medstar Health Research Institute, Baptist Memorial Health Care Corporation, Mayo Clinic
- Study start
- Apr 1998
- Study completion
- Nov 2001 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: Intercessory Prayer604 patients received intercessory prayer after being informed they may or may not receive prayers (Group 1) |
| 2 | No intervention | –597 patients did not receive prayer after being informed they may or may not receive prayer (Group 2) |
| Group 3 | Experimental | Behavioral: Intercessory Prayer601 patients received intercessory prayer after being informed they would receive it (Group 3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Able to read or understand English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intercessory Prayer14 days of intercessory prayer from 3 sites | Behavioural | Group 1, Group 3 |
Primary outcome
Whether receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.
Time frame: 30 days
1 secondary outcome
Whether being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Benson, MD principal investigator
Beth Israel Deaconess Medical Center, Mind/Body Medical Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intercessory Prayer in people with Coronary Artery Bypass Grafting Surgery, run by Beth Israel Deaconess Medical Center.
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 2 inclusion and 6 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 5 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Whether receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2007.