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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stress	Other: Rest; Other: Sham; Other: Reiki	Phase 1

Detailed Description:

See Brief Summary

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 257 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Reiki on Physiological Consequences of Acute Stress
• Study Start Date: January 2006
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: June 2010

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Supine Rest; 30min supine rest listening to soft music	Other: Rest; 30 min supine rest
Sham Comparator: Sham Reiki; 30 min intervention by sham practitioner	Other: Sham; 30 min session with Sham practitioner; Other Names: Touch; Pretend Reiki; Placebo Reiki
Experimental: Reiki; 30 min session with Reiki practitioner	Other: Reiki; 30 min session with Reiki practitioner; Other Names: Energy Healing; Energy Therapy; Touch Therapy

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Assess which benefits result from placebo and which from unique abilities of Reiki practitioners [ Time Frame: 3 years ]
2. Obtain preliminary information on mechanisms needed for the rational design of a larger clinical trial [ Time Frame: 3 years ]
3. Assess the role of a variety of baseline variables on responses. [ Time Frame: 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

More Information

• Responsible Party: Joan Fox, Staff, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00346671
• Other Study ID Numbers: R21AT001884-01 ( U.S. NIH Grant/Contract )
• First Posted: June 30, 2006
• Last Update Posted: September 24, 2012
• Last Verified: September 2012

Keywords provided by Joan Fox, The Cleveland Clinic:

Reiki; Stress; CAM