Effectiveness of Laying-on-of-hands for Sickle Cell Disease
Primary Purpose
Sickle Cell Disease, Pain Crisis Recurrent, Anemia
Status
Completed
Phase
Phase 2
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
laying-on-of-hands
Sponsored by
About this trial
This is an interventional supportive care trial for Sickle Cell Disease focused on measuring Sickle cell disease, laying-on-of-hands, morbidity, mortality
Eligibility Criteria
Inclusion Criteria:
- patients with symptoms associated with sickle cell disease
- those able to receive laying-on-of-hands every weekday for 1 year
- those able to receive conventional medical treatment whenever necessary
- those able to receive blood test at the beginning, after 6 month and after 1 year
Exclusion Criteria:
- those who wish to use other complementary and alternative therapies along with laying-on-of-hands
Sites / Locations
- The national medical center for sickle cell disease
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
laying-on-of-hands
control group
Arm Description
Patients of this arm received laying-on-of-hands twice a day (45 minutes each) every weekday for 1year, and received conventional medical treatment if necessary.
Patients of this arm did not receive any alternatives other than conventional treatment.
Outcomes
Primary Outcome Measures
disease-related episodes and mortality
Secondary Outcome Measures
blood data
Full Information
NCT ID
NCT01518218
First Posted
January 21, 2012
Last Updated
April 9, 2015
Sponsor
MOA Health Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01518218
Brief Title
Effectiveness of Laying-on-of-hands for Sickle Cell Disease
Official Title
Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MOA Health Science Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in Africa.
Detailed Description
Patients with sickle cell disease (SCD) have a high risk of premature death in Africa, mainly due to insufficient medical services. SCD patients often visit emergency department and need hospitalization when they suffer from severe pain; however, they manage most of painful episodes at home. Appropriate pain management at home is, therefore, crucial to improve their clinical course and quality of life. Laying-on-of-hands may be a good candidate for home care management, because family member(s) can become a practitioner of laying-on-of-hands without difficulty and administer it to their loved one as an initial treatment whenever necessary. There are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of SCD patients, as far as we have investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Pain Crisis Recurrent, Anemia, Infection, Death
Keywords
Sickle cell disease, laying-on-of-hands, morbidity, mortality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laying-on-of-hands
Arm Type
Experimental
Arm Description
Patients of this arm received laying-on-of-hands twice a day (45 minutes each) every weekday for 1year, and received conventional medical treatment if necessary.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients of this arm did not receive any alternatives other than conventional treatment.
Intervention Type
Behavioral
Intervention Name(s)
laying-on-of-hands
Other Intervention Name(s)
Okada Purifying Therapy, biofield therapy
Intervention Description
The intervention group received laying-on-of-hands every weekday for 1 year along with conventional medicine. The control group did not undergo any alternatives to OPT.
Primary Outcome Measure Information:
Title
disease-related episodes and mortality
Time Frame
3 years and 9 months
Secondary Outcome Measure Information:
Title
blood data
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with symptoms associated with sickle cell disease
those able to receive laying-on-of-hands every weekday for 1 year
those able to receive conventional medical treatment whenever necessary
those able to receive blood test at the beginning, after 6 month and after 1 year
Exclusion Criteria:
those who wish to use other complementary and alternative therapies along with laying-on-of-hands
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kodondi K Koto, MD, PhD
Organizational Affiliation
The Institute of Scientific Research for Health, Kinshasa
Official's Role
Study Director
Facility Information:
Facility Name
The national medical center for sickle cell disease
City
Kinshasa
Country
Congo, The Democratic Republic of the
12. IPD Sharing Statement
Citations:
PubMed Identifier
24445353
Citation
Minga TM, Koto FK, Egboki H, Suzuki K. Effectiveness of biofield therapy for individuals with sickle cell disease in Africa. Altern Ther Health Med. 2014 Jan-Feb;20(1):20-6.
Results Reference
derived
Links:
URL
http://www.moainternational.or.jp
Description
MOA International Corporation
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Effectiveness of Laying-on-of-hands for Sickle Cell Disease
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