Reiki/Energy Healing in Prostate Cancer

September 20, 2012 updated by: Joan Fox, The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reiki
Energy therapy
Behavioral: Reiki
Energy therapy - 8 biweekly sessions of 30 minutes
Other Names:
  • Energy Healing
  • Energy Therapy
  • Touch Therapy
Sham Comparator: Pretend Reiki
Behavioral: Pretend Reiki
Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
Other Names:
  • Touch
Other: 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 Names:
  • Guided Imagery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Joan Fox, Ph.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

July 18, 2003

First Submitted That Met QC Criteria

July 21, 2003

First Posted (Estimate)

July 22, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT001120 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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