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

Anemia Clinical Trial

Official title:

Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518218
• Other study ID #: MOA-002
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2012
• Last updated: April 9, 2015
• Start date: March 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2012
• Source: MOA Health Science Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Death
• Infection
• Pain Crisis Recurrent
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
Congo, The Democratic Republic o	The national medical center for sickle cell disease	Kinshasa

Sponsors (1)

Lead Sponsor	Collaborator
MOA Health Science Foundation

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-related episodes and mortality		3 years and 9 months	Yes
Secondary	blood data		1 year	Yes

External Links

•   MOA International Corporation