Back to resultsReiki/Energy Healing in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Reiki
Pretend Reiki
Rest / Guided Imagery
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Reiki, Energy Healing
Eligibility 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
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
Reiki
Pretend Reiki
Rest / Guided Imagery
Arm Description
Energy therapy
Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes
Outcomes
Primary Outcome Measures
To evaluate the effects of Reiki on anxiety states using validated psychometric instruments.
To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels
To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma.
Secondary Outcome Measures
To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms
Full Information
NCT ID
NCT00065208
First Posted
July 18, 2003
Last Updated
September 20, 2012
Sponsor
The Cleveland Clinic
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00065208
Brief Title
Reiki/Energy Healing in Prostate Cancer
Official Title
Effects of Energy Healing on Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Reiki, Energy Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reiki
Arm Type
Experimental
Arm Description
Energy therapy
Arm Title
Pretend Reiki
Arm Type
Sham Comparator
Arm Title
Rest / Guided Imagery
Arm Type
Other
Arm Description
Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes
Intervention Type
Behavioral
Intervention Name(s)
Reiki
Other Intervention Name(s)
Energy Therapy, Touch Therapy, Energy Healing
Intervention Description
Energy therapy - 8 biweekly sessions of 30 minutes
Intervention Type
Behavioral
Intervention Name(s)
Pretend Reiki
Other Intervention Name(s)
Touch
Intervention Description
Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
Intervention Type
Behavioral
Intervention Name(s)
Rest / Guided Imagery
Other Intervention Name(s)
Guided Imagery
Intervention Description
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)
Primary Outcome Measure Information:
Title
To evaluate the effects of Reiki on anxiety states using validated psychometric instruments.
Time Frame
Each 30 minute session
Title
To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels
Time Frame
Each 30 minute session
Title
To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma.
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms
Time Frame
Throughout study
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Fox, Ph.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reiki/Energy Healing in Prostate Cancer
We'll reach out to this number within 24 hrs