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Reiki/Energy Healing in Prostate Cancer

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: NCT00065208
Recruitment Status : Completed
First Posted : July 22, 2003
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

Study Description
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Brief Summary:
The purpose of this study is to determine whether Reiki energy healing affects anxiety and disease progression in patients with localized prostate cancer who are candidates for radical prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Reiki Behavioral: Pretend Reiki Behavioral: Rest / Guided Imagery Phase 1 Phase 2

Detailed Description:
120 newly diagnosed prostate cancer patients will be randomized to one of 3 groups: Reiki, another touch therapy, or guided imagery. Subjects in the Reiki and touch therapy groups have 8 sessions in the 4 weeks prior to their medical intervention. Those in the imagery group have one session prior to their medical intervention.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Energy Healing on Prostate Cancer
Study Start Date : April 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Reiki
Energy therapy
 Behavioral: Reiki
Energy therapy - 8 biweekly sessions of 30 minutes
Other Names:
  • Energy Therapy
  • Touch Therapy
  • Energy Healing
Sham Comparator: Pretend Reiki Behavioral: Pretend Reiki
Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
Other Name: Touch
Rest / Guided Imagery
Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes
 Behavioral: Rest / Guided Imagery
4 weekly sessions of 30 supine rest listening to soft music. One session of Guided Imagery followed at visit 9. Listen to CDs twice a day 3 days prior to and 2 days following surgery (affect only post surgery outcomes)
Other Name: Guided Imagery


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the effects of Reiki on anxiety states using validated psychometric instruments. [ Time Frame: Each 30 minute session ]
  2. To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels [ Time Frame: Each 30 minute session ]
  3. To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma. [ Time Frame: throughout study ]

Secondary Outcome Measures :
  1. To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Newly diagnosed with prostate cancer
  • Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these

Exclusion criteria:

  • Already involved in energy healing treatments
  • Any patient whose medical intervention could not wait the 4-weeks for intervention for medical reasons
  • Any patient who gets neo-adjuvant therapy or any herbal product that could affect PSA
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065208


Locations
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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
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Principal Investigator: Joan Fox, Ph.D. The Cleveland Clinic
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Joan Fox, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00065208    
Other Study ID Numbers: R21AT001120 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by Joan Fox, The Cleveland Clinic:
Prostate cancer
Reiki
Energy Healing
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases