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Effectiveness of Laying-on-of-hands for Sickle Cell Disease

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: NCT01518218
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Pain Crisis Recurrent Anemia Infection Death Behavioral: laying-on-of-hands Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa
Study Start Date : March 2006
Primary Completion Date : March 2007
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: laying-on-of-hands
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.
Behavioral: laying-on-of-hands
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.
Other Names:
  • Okada Purifying Therapy
  • biofield therapy
No Intervention: control group
Patients of this arm did not receive any alternatives other than conventional treatment.


Outcome Measures

Primary Outcome Measures :
  1. disease-related episodes and mortality [ Time Frame: 3 years and 9 months ]

Secondary Outcome Measures :
  1. blood data [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT01518218


Locations
Congo, The Democratic Republic of the
The national medical center for sickle cell disease
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
MOA Health Science Foundation
Investigators
Study Director: Kodondi K Koto, MD, PhD The Institute of Scientific Research for Health, Kinshasa
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kiyoshi Suzuki, president, MOA Health Science Foundation
ClinicalTrials.gov Identifier: NCT01518218     History of Changes
Other Study ID Numbers: MOA-002
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: January 2012

Keywords provided by Kiyoshi Suzuki, MOA Health Science Foundation:
Sickle cell disease
laying-on-of-hands
morbidity
mortality

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn