Effects of Reiki on Stress

NCT00346671 | Completed Phase 1 DMC

• 1 other identifier: R21AT001884-01
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Reiki; Stress; CAM

Outcome Measures

Primary Outcomes (2)

• 1: To determine whether a Reiki session affects emotional states, ANS, or HPA activity

  3 years

• 2. To determine whether a Reiki session affects responses to a subsequent acute stressor

  3 years

Secondary Outcomes (3)

• Assess which benefits result from placebo and which from unique abilities of Reiki practitioners

  3 years

• Obtain preliminary information on mechanisms needed for the rational design of a larger clinical trial

  3 years

• Assess the role of a variety of baseline variables on responses.

  3 years

Study Arms (3)

Supine Rest

PLACEBO COMPARATOR

30min supine rest listening to soft music

Other: Rest

Sham Reiki

SHAM COMPARATOR

30 min intervention by sham practitioner

Other: Sham

Reiki

EXPERIMENTAL

30 min session with Reiki practitioner

Other: Reiki

Interventions

Rest OTHER

30 min supine rest

Supine Rest

Sham OTHER

30 min session with Sham practitioner

Also known as: Touch, Pretend Reiki, Placebo Reiki

Sham Reiki

Reiki OTHER

30 min session with Reiki practitioner

Also known as: Energy Healing, Energy Therapy, Touch Therapy

Reiki

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Individuals between the age of 18 and 75

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

RE1-silencing transcription factor; salicylhydroxamic acid; Touch; Therapeutic Touch

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Joan E. Fox, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: June 30, 2006
• Study Start: January 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2010
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

US (1)