Effects of Reiki on Stress

• ClinicalTrials.gov Identifier: NCT00346671
• Recruitment Status: Completed
• First Posted: June 30, 2006
• Last Update Posted: September 24, 2012
• Sponsor: The Cleveland Clinic
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Joan Fox, The Cleveland Clinic

Tracking Information

• First Submitted Date: June 29, 2006
• First Posted Date: June 30, 2006
• Last Update Posted Date: September 24, 2012
• Study Start Date: January 2006
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Effects of Reiki on Stress
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stress

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 20, 2012): 257
• Original Enrollment (submitted: June 29, 2006): 420
• Actual Study Completion Date: June 2010
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00346671
• Other Study ID Numbers: R21AT001884-01( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Joan Fox, The Cleveland Clinic
• Original Responsible Party: Not Provided
• Current Study Sponsor: The Cleveland Clinic
• Original Study Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Joan E. Fox, PhD; The Cleveland Clinic

• PRS Account: The Cleveland Clinic
• Verification Date: September 2012