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Effects of Reiki on Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00346671
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : September 24, 2012
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Joan Fox, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE June 29, 2006
First Posted Date  ICMJE June 30, 2006
Last Update Posted Date September 24, 2012
Study Start Date  ICMJE January 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2008)
  • 1: To determine whether a Reiki session affects emotional states, ANS, or HPA activity [ Time Frame: 3 years ]
  • 2. To determine whether a Reiki session affects responses to a subsequent acute stressor [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
  • 1: To determine whether a 30 min Reiki session affects emotional states, ANS activity, or HPA
  • activity, as compared to three control groups.
  • 1a. Heart rate, skin conductance, and plasma catecholamines will assess sympathetic nervous system (SNS)
  • activity
  • 1b. High frequency spectrum of heart rate variability will assess parasympathetic nervous system (PNS) activity
  • 1c. Salivary cortisol will assess HPA activity
  • 1d. Validated inventories will assess psychological states
  • 1e. EEG recording will assess brain activity
  • 1f. Plasma Dehydroepiandrosterone (DHEA) and salivary melatonin will be assessed as potential mechanisms for
  • mediating enhanced wellbeing
  • 2. To determine whether a 30 min Reiki session affects responses to a subsequent acute
  • laboratory stressor, as compared to three control groups.
  • 2a. Heart rate, skin conductance, and circulating catecholamine levels will assess changes in SNS activity
  • 2b. High frequency spectrum of heart rate variability will assess changes in PNS activity
  • 2c. Salivary cortisol will assess changes in HPA activity
  • 2d. Validated inventories will assess changes in psychological states
  • 2e. EEG recording will assess changes in brain activity
  • 2f. Natural killer cell count will assess changes in immune cell function
  • 2g. Plasma platelet factor 4 levels will assess changes in platelet activation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2008)
  • Assess which benefits result from placebo and which from unique abilities of Reiki practitioners [ Time Frame: 3 years ]
  • Obtain preliminary information on mechanisms needed for the rational design of a larger clinical trial [ Time Frame: 3 years ]
  • Assess the role of a variety of baseline variables on responses. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
  • Assess which benefits result from placebo, empathetic intentions, or
  • unique abilities of "attuned" Reiki Masters
  • Obtain preliminary information on mechanisms needed for the rational design
  • of future studies
  • Assess the role of a variety of baseline variables on responses.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Reiki on Stress
Official Title  ICMJE Effects of Reiki on Physiological Consequences of Acute Stress
Brief Summary 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.
Detailed Description See Brief Summary
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stress
Intervention  ICMJE
  • Other: Rest
    30 min supine rest
  • Other: Sham
    30 min session with Sham practitioner
    Other Names:
    • Touch
    • Pretend Reiki
    • Placebo Reiki
  • Other: Reiki
    30 min session with Reiki practitioner
    Other Names:
    • Energy Healing
    • Energy Therapy
    • Touch Therapy
Study Arms  ICMJE
  • Placebo Comparator: Supine Rest
    30min supine rest listening to soft music
    Intervention: Other: Rest
  • Sham Comparator: Sham Reiki
    30 min intervention by sham practitioner
    Intervention: Other: Sham
  • Experimental: Reiki
    30 min session with Reiki practitioner
    Intervention: Other: Reiki
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2012)
257
Original Enrollment  ICMJE
 (submitted: June 29, 2006)
420
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00346671
Other Study ID Numbers  ICMJE R21AT001884-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Joan Fox, The Cleveland Clinic
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE The Cleveland Clinic
Original Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Joan E. Fox, PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP