- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00346671
Effects of Reiki on Stress
September 20, 2012 updated by: Joan Fox, The Cleveland Clinic
Effects of Reiki on Physiological Consequences of Acute Stress
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.
Study Overview
Detailed Description
See Brief Summary
Study Type
Interventional
Enrollment (Actual)
257
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Supine Rest
30min supine rest listening to soft music
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30 min supine rest
|
Sham Comparator: Sham Reiki
30 min intervention by sham practitioner
|
30 min session with Sham practitioner
Other Names:
|
Experimental: Reiki
30 min session with Reiki practitioner
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30 min session with Reiki practitioner
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1: To determine whether a Reiki session affects emotional states, ANS, or HPA activity
Time Frame: 3 years
|
3 years
|
2. To determine whether a Reiki session affects responses to a subsequent acute stressor
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess which benefits result from placebo and which from unique abilities of Reiki practitioners
Time Frame: 3 years
|
3 years
|
Obtain preliminary information on mechanisms needed for the rational design of a larger clinical trial
Time Frame: 3 years
|
3 years
|
Assess the role of a variety of baseline variables on responses.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joan E. Fox, PhD, The Cleveland Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
June 29, 2006
First Submitted That Met QC Criteria
June 29, 2006
First Posted (Estimate)
June 30, 2006
Study Record Updates
Last Update Posted (Estimate)
September 24, 2012
Last Update Submitted That Met QC Criteria
September 20, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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