Effects of Reiki on Stress

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joan Fox, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00346671
First received: June 29, 2006
Last updated: September 20, 2012
Last verified: September 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Enrollment: 257
Study Start Date: January 2006
Study Completion Date: June 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Joan E. Fox, PhD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Joan Fox, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00346671     History of Changes
Other Study ID Numbers: R21 AT001884-01
Study First Received: June 29, 2006
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by The Cleveland Clinic:
Reiki
Stress
CAM

ClinicalTrials.gov processed this record on July 29, 2014