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Reiki/Energy Healing in Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Joan Fox, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00065208
First received: July 18, 2003
Last updated: September 20, 2012
Last verified: September 2012
History of Changes

July 18, 2003
September 20, 2012
April 2005
June 2010   (final data collection date for primary outcome measure)
  • To evaluate the effects of Reiki on anxiety states using validated psychometric instruments. [ Time Frame: Each 30 minute session ] [ Designated as safety issue: No ]
  • To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels [ Time Frame: Each 30 minute session ] [ Designated as safety issue: No ]
  • To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00065208 on ClinicalTrials.gov Archive Site
To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Reiki/Energy Healing in Prostate Cancer
Effects of Energy Healing on Prostate Cancer

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostate Cancer
  • Behavioral: Reiki
    Energy therapy - 8 biweekly sessions of 30 minutes
    Other Names:
    • Energy Therapy
    • Touch Therapy
    • Energy Healing
  • Behavioral: Pretend Reiki
    Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
    Other Name: Touch
  • 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
  • Experimental: Reiki
    Energy therapy
    Intervention: Behavioral: Reiki
  • Sham Comparator: Pretend Reiki
    Intervention: Behavioral: Pretend Reiki
  • Rest / Guided Imagery
    Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes
    Intervention: Behavioral: Rest / Guided Imagery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065208
R21 AT001120
Yes
Joan Fox, The Cleveland Clinic
The Cleveland Clinic
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Joan Fox, Ph.D. The Cleveland Clinic
The Cleveland Clinic
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP