Suzanne W. Crater

Music, imagery, touch, and prayer as adjuncts to interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study

BACKGROUND Data from a pilot study suggested that noetic therapies-healing practices that are not mediated by tangible elements-can reduce preprocedural distress and might affect outcomes in patients undergoing percutaneous coronary intervention. We undertook a multicentre, prospective trial of two such practices: intercessory prayer and music, imagery, and touch (MIT) therapy. METHODS 748 patients undergoing percutaneous coronary intervention or elective catheterisation in nine USA centres were assigned in a 2x2 factorial randomisation either off-site prayer by established congregations of various religions or no off-site prayer (double-blinded) and MIT therapy or none (unmasked). The primary endpoint was combined in-hospital major adverse cardiovascular events and 6-month readmission or death. Prespecified secondary endpoints were 6-month major adverse cardiovascular events, 6 month death or readmission, and 6-month mortality. FINDINGS 371 patients were assigned prayer and 377 no prayer; 374 were assigned MIT therapy and 374 no MIT therapy. The factorial distribution was: standard care only, 192; prayer only, 182; MIT therapy only, 185; and both prayer and MIT therapy, 189. No significant difference was found for the primary composite endpoint in any treatment comparison. Mortality at 6 months was lower with MIT therapy than with no MIT therapy (hazard ratio 0.35 (95% CI 0.15-0.82, p=0.016). INTERPRETATION Neither masked prayer nor MIT therapy significantly improved clinical outcome after elective catheterisation or percutaneous coronary intervention.

Electrocardiographic Differentiation of the ST-Segment Depression of Acute Myocardial Injury Due to the Left Circumflex Artery Occlusion from that of Myocardial Ischemia of Nonocclusive Etiologies

Lead distributions of peak ST-segment depression were compared between patients undergoing left circumflex artery percutaneous transluminal coronary angioplasty and exercise tolerance test. Localization of peak ST-segment depression to leads V2 or V3 was 96% specific and 70% sensitive for differentiating ischemia due to occlusion of left circumflex artery occlusion from nonocclusive ischemia.

Beneficial effects of noetic therapies on mood before percutaneous intervention for unstable coronary syndromes.

Background:Many common medical, surgical, and diagnostic procedures performed for conscious patients can be accompanied by significant anxiety. Mind-body-spirit interventions could serve as useful adjunctive treatments for the reduction of stress. Objective:To evaluate the effects of stress management, imagery, touch therapy, remote intercessory prayer, and standard therapy on mood in patients awaiting percutaneous interventions for unstable coronary syndromes as part of the Monitoring and Actualization of Noetic Training (MANTRA) trial, which explored the feasibility and efficacy of noetic interventions on clinical outcomes in a randomized clinical trial. Methods:A total of 150 patients were randomized to one of the five treatment conditions. Stress management, imagery, and touch therapy were administered in 30-minute treatment sessions immediately before the cardiac intervention. Intercessory prayer was not necessarily contemporaneous with these treatments. Mood was assessed by a set of visual analog scales before and after treatment for a similar length of time for the standard therapy and prayer groups. Results:Analysis of complete data from 108 patients showed that stress management, imagery, and touch therapy all produced reductions in reported worry, as compared with standard therapy, whereas remote intercessory prayer had no effect on mood. The ratings of other similar moods were not affected, perhaps because of the relatively positive emotional state observed in the participants before treatment. Conclusions:The results suggest that at least some noetic therapies may have beneficial effects on mood in the course of medical and surgical interventions. Administration of these interventions was feasible even in the hectic environment of the coronary intensive care unit. Given their relatively low cost and limited potential for adverse effects, these interventions merit further study as therapeutic adjuncts.

Clinical utility of serial and continuous ST-segment recovery assessment in patients with acute ST-elevation myocardial infarction: assessing the dynamics of epicardial and myocardial reperfusion.

Acute ST-segment–elevation myocardial infarction (STEMI) is a global source of mortality and morbidity and consequently is one of the most active areas of applied research. In the face of multiple reports of new combinations of medical and interventional therapies, the challenge to the clinician is both to understand data from key clinical trials and to translate that understanding to the individual patient at the bedside. STEMI is defined by “ST elevation” on the ECG, which is the electrical manifestation of the pathophysiological changes that follow a thrombotic occlusion of an epicardial coronary artery.1 The ECG is ubiquitous in cardiology, applied as a diagnostic, prognostic, and management tool. Although a single ECG presents about 10 seconds of waveform morphology, acute STEMI displays its dynamic behavior over time, both spontaneously and in response to therapy. The systematic use of serial and continuous ECG assessments has been one of the most fertile areas of advancement in the ability to measure and thereby recognize the presence, speed, quality, and stability of reperfusion of an infarct artery. In addition to providing insights into pathophysiological mechanisms and novel therapies in research protocols, serial or continuous use of this simple, noninvasive, quantitative measure has the potential to guide clinicians through the dynamic events surrounding the management of STEMI patients’ disease. This is illustrated in the following case studies of 3 patients, all of whom presented with 3 hours of chest pain with angiographically documented Thrombolysis in Myocardial Infarction (TIMI) 3 flow, were managed with serial ECGs for clinical purposes, and were simultaneously monitored for research protocols with “black box” continuous 12-lead ECG monitors. ### Patient 1 G.E. was a 67-year-old man with a history of hypertension and tobacco use who presented with 3 hours of chest pain. The initial ECG showed anterolateral ST-segment elevation with a maximum of 15 …

Correlations between preprocedure mood and clinical outcome in patients undergoing coronary angioplasty.

We studied the relationship between mood and mood shift immediately before percutaneous coronary intervention (PCI) and 3 end points: total ischemic burden during PCI, adverse cardiac end points (ACE) after PCI, and death by 6-month follow up. Patients (n = 119) with unstable angina or myocardial infarction completed a visual analog scale (VAS) twice before PCI; before and after a session of stress relaxation, imagery, or touch; or approximately 30 minutes apart for patients assigned to prayer or to standard care. VAS included happiness, satisfaction, calm, hope, worry, shortness of breath, fear, and sadness. We observed a significant correlation between higher hope score before PCI and lower ischemic burden. Patients who experienced ACE had significantly lower hope and happiness scores than those who did not. Patients who survived to 6 months had significantly greater increases in worry and in hope. Our data suggest correlations between simple mood assessments before PCI and clinical outcomes during and after the procedure. More study is needed to understand whether attempts to alter patient mood can affect clinical outcomes.

What do "we" want and need to know about prayer and healing?

In 2005, the Monitoring & Actualization of Noetic TRAinings (MANTRA) II study was published in The Lancet— the first prospective, multicenter clinical trial of prayer in patients with heart disease. On the first day the press embargo on this report was lifted, a newspaper headline announced to the world: ‘‘God Fails Test.’’ When results of an even larger multicenter trial, the Study of Therapeutic Effects of Intercessory Prayer (STEP), in patients undergoing heart surgery was later published in the American Heart Journal, similarly simplistic and sensationalized media coverage provided study ‘‘results’’ to the public. Translating medical findings into meaningful public and professional messages is challenging in any clinical trial, and is even more challenging when studying something as intangible, and as politically and polemically charged, as the role of prayer in healing. While prayer is arguably the oldest and most ubiquitous of all healing therapeutics, we must recognize that the scientific literature on prayer is in its infancy. We have no mechanistic understanding whatsoever as to how prayer actually operates in the practice of medicine. The very fact that serious scientific research into prayer and healing is coming forward, and not from schools of voodoo, but from the Mayo Clinic, Duke University, Columbia University, and Harvard, is significant. Whether as scientists, the lay public, or the media, ‘‘we’’ are all destined to become patients in need of optimal medical care sooner or later, and so might reflect together on whether narrow and contentious debate about any single study examining whether prayer heals is nearly as important as the trend of leading academic researcher centers developing serious interest in whether intangible human capacities such as compassion, love, joy, the human spirit, or prayer can measurably augment the outcomes we see within the allopathic application of our most advanced medical technologies. Clinical studies of such ubiquitous healing practices as prayer, with no plausible mechanistic explanation, can be meaningful, but cannot be represented as ‘‘pass=fail’’ tests by anyone, either clinicians or media. Well-designed studies may serve as efforts to structure information so that we might all learn something—specifically about the role, effects, or even possibly some of the mechanisms through which intangible adjuncts might improve outcomes in our high-tech world of health care. Most predictably, the role of scientific inquiry in such early stages of research will be useful to fashion better, clearer questions, or hypotheses; and for the advance of medical practice, clinical research applying clearer, more informed questions provides the real substrate from which more definitive, more impactful answers may arise. As ongoing interest propels further studies from leading research centers, we might briefly reflect on just what it is that we want and need to know about prayer and healing. At this early stage, when we are still unclear how a ‘‘dose’’ of healing prayer might even be defined, clinical trials are best understood by their context, rather than simply by their specific findings or other provocative details.

Prayer and Cardiovascular Disease

Prayer has been an important part of human existence for thousands of years. People turn to a prayer in times of reflection, gratitude, and crisis, including physical illness. Surveys have shown that more than 90% of people believe in a Higher Being (1,2). In a recent survey of complementary and alternative medicine (CAM) in the United States, 35% of people reported that they had used prayer as a therapy for their personal health concerns (3). A study conducted in 1996 demonstrated that 96% of Americans believe in God, at least 90% pray, and more than 40% had attended organized religious services during the past week (4). This chapter explores the relationship between prayer and cardiovascular disease (CVD) by providing terms for evaluating prayer and spirituality in a modern medical setting, by discussing the literature to date and by considering implications for future research.

Novel applications of ECG monitoring for the quantification of noetic phenomena

Abstract A safety and efficacy study of nondrug, nondevice “noetic” medical interventions requires unique clinical trial design elements and tools. Although the precise mechanisms through which meditative or spiritual practices might influence clinical outcomes may be difficult to define, intuitively any such intervention that could meaningfully alter human physiology would be likely to be mediated through vascular tone, autonomic nervous system tone, or both. Continuous electrocardiographic monitoring in patients with coronary artery disease provides an objective, noninvasive modality through which coronary vascular insufficiency (ischemia) and spectro-temporal parameters of heart rate variability can be analyzed in an experienced core laboratory setting blinded to patient treatment assignments. We applied this approach in 150 patients with unstable angina and acute myocardial infarction undergoing invasive coronary catheterization and angioplasty who were randomized to one of five therapies (healing touch, stress relaxation training, imagery, double-blinded off-site intercessory prayer, or standard therapy) in the Monitoring & Actualization of Noetic TRAinings (MANTRA) Feasibility Pilot Study. Using a uniquely modified Marquette Electronics Tramscope 12-lead ST-Guard/MARS Holter “Unity” configuration (Milwaukee, WI), a “seamless” monitoring capability allowed monitoring to continue uninterrupted as patients went from the CCU to the catheterization lab and back to the CCU, creating a “rest-stress-recovery” data set similar to the common exercise stress test paradigm.