- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01518218
Effectiveness of Laying-on-of-hands for Sickle Cell Disease
April 9, 2015 updated by: Kiyoshi Suzuki, MOA Health Science Foundation
Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
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
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Kinshasa, Congo, The Democratic Republic of the
- The national medical center for sickle cell disease
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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
3 years to 40 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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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:
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NO_INTERVENTION: control group
Patients of this arm did not receive any alternatives other than conventional treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease-related episodes and mortality
Time Frame: 3 years and 9 months
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3 years and 9 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood data
Time Frame: 1 year
|
1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kodondi K Koto, MD, PhD, The Institute of Scientific Research for Health, Kinshasa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Helpful Links
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
March 1, 2006
Primary Completion (ACTUAL)
March 1, 2007
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
January 21, 2012
First Submitted That Met QC Criteria
January 21, 2012
First Posted (ESTIMATE)
January 25, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
April 13, 2015
Last Update Submitted That Met QC Criteria
April 9, 2015
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOA-002
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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