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

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

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.
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:
  • biofield therapy
  • Okada Purifying Therapy
NO_INTERVENTION: control group
Patients of this arm did not receive any alternatives other than conventional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-related episodes and mortality
Time Frame: 3 years and 9 months
3 years and 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
blood data
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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