Effects of Reiki on Stress - Full Text View

Sponsor:	The Cleveland Clinic
Collaborator:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00346671

Purpose

Complementary therapies such as Reiki are becoming popular. Reiki is a practice used for relaxation and pain management that involves physical touch and social contact with a trained, empathetic practitioner. Unlike many relaxation therapies, Reiki requires no participation by the patient, a feature that makes Reiki particularly attractive in the hospital setting, where patients are often extremely anxious, depressed, in pain, or sedated. Our primary research questions are to determine whether physiological changes are induced during a Reiki session and whether a Reiki session affects responses to a subsequent acute stressor. Secondary research questions include assessing which benefits result from placebo or unique abilities of "attuned" Reiki practitioners and assessing background characteristics of recipients that are associated with acceptance and responsiveness. Based on its use to reduce pain and anxiety, we will study potential mechanisms by which Reiki decreases activity of the sympathetic nervous system and other stress pathways. Comparison of the responses in a Reiki group with those in supine-control and sham groups will allow us to gain insights into mechanisms by which Reiki effects are mediated. Information obtained from the proposed studies will provide detailed information on physiological pathways affected by Reiki. Should Reiki decrease stress pathways or reduce physiological responses to stressful situations, it could be a useful adjunct to traditional medicine and have significant health and economic benefits.

Condition	Intervention	Phase
Stress	Other: Rest Other: Sham Other: Reiki	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Reiki on Physiological Consequences of Acute Stress

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

1: To determine whether a Reiki session affects emotional states, ANS, or HPA activity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
2. To determine whether a Reiki session affects responses to a subsequent acute stressor [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess which benefits result from placebo and which from unique abilities of Reiki practitioners [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Obtain preliminary information on mechanisms needed for the rational design of a larger clinical trial [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Assess the role of a variety of baseline variables on responses. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	420
Study Start Date:	January 2006
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Supine Rest: Placebo Comparator 30min supine rest listening to soft music	Other: Rest 30 min supine rest
Sham Reiki: Sham Comparator 30 min intervention by sham practitioner	Other: Sham 30 min session with Sham practitioner
Reiki: Experimental 30 min session with Reiki practitioner	Other: Reiki 30 min session with Reiki practitioner

Detailed Description:

See Brief Summary

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Individuals between the age of 18 and 75

Exclusion Criteria:

Already involved in regular (one time a week or more) mind-body practices (yoga, meditation, Qi-gong, guided imagery, Taichi, biofeedback; attendance at religious services is not considered a mind-body practice) in the past three months OR has been doing intense spiritual practice for more than 6 months in the past (an average of 6hrs a week)
Already received an energy therapy treatment (Reiki, therapeutic touch, healing touch, touch therapy) in the past. (note: acupuncture, massage Qi-gong are not considered energy therapies in the context of this study)
Score on the DASS21 for Depression greater or equal to 21
Score on the DASS21 for Anxiety greater or equal to 15
In the last 3 months, has had a major stressful life-event that is likely to affect the outcomes of the study
Medical condition, current illness or history of chronic illness that might affect the outcomes of the study such as those affecting stress response, cardiovascular, endocrine, or immune systems (Examples: cancer, lupus, multiple sclerosis, blood-clotting disorder, severe allergies or asthma that impairs breathing, diabetes mellitus, hyperglycemia, or hypoglycemia, cardiovascular disease, depression/anxiety etc.)
In the past 3 months, has used or is chronically using over-the-counter, recreational or prescription drugs that might affect the outcomes of the study such as those affecting cardiovascular, platelets, central nervous system, endocrine, immune systems(Examples: steroid, blood pressure medication, depression/anxiety medication, antiplatelet drugs, etc.)
Color Blind
Consume 3 or more alcoholic drinks per day most days over the 3 months
Pregnant
Problems donating blood: Fear of hypodermic needles; has felt dizzy or was about to faint following a needle stick
Incompatibility of energy healing with religious beliefs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346671

Contacts

Contact: Didier Allexandre

216-445-1818

allexad@ccf.org

Locations

United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Joan E. Fox, PhD

The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic ( Dr Joan Fox )
Study ID Numbers:	R21 AT001884-01
Study First Received:	June 29, 2006
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00346671 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by The Cleveland Clinic:

Reiki
Stress
CAM

Additional relevant MeSH terms:

Pathologic Processes
Stress

ClinicalTrials.gov processed this record on February 08, 2010