- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994809
International Study of Biofield Therapy
June 19, 2019 updated by: Kiyoshi Suzuki, MOA Health Science Foundation
International Cross-sectional Study on the Effectiveness of Biofield Therapy for the Relief of Various Symptoms
Participants from 14 different countries received a single session of biofield therapy (Okada Purifying Therapy) lasting 30 minutes or longer from the volunteer practitioners.
Before and after the therapy, they reported the severity of physical pain, anxiety/depression, dizziness/palpitation, and overall symptoms.
The team compared the effectiveness/safety of biofield therapy between countries and analyzed the factors associated with the outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants aged 16 or older from 14 different countries (Japan, USA, Argentina, Brazil, Chile, Mexico, Peru, Taiwan, Thai, South Korea, Belgium, France, Portugal, and Spain) received a single session of biofield therapy (Okada Purifying Therapy) lasting 30 minutes or longer from the volunteer practitioners in their country of residence.
Before and after the intervention, they reported each severity level of physical pain, anxiety/depression, dizziness/palpitation, and overall symptoms.
The team compared the improvement/exacerbation rate of a single session of biofield therapy between the countries, and examined the adjusted odds ratio of the variables associated with the changes in each category of symptoms in a real-world setting.
Study Type
Observational
Enrollment (Actual)
12000
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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants were recruited in various settings, including the workshop, the investigator's house, or the participant's home in 14 different countries.
Description
Inclusion Criteria:
- Individuals who agreed to receive a single session of biofield therapy for 30 minutes or longer from the volunteer investigators.
- Individuals who were able to self-evaluate the change of their symptoms.
- Individuals who were competent to answer the questionnaires.
- Individuals who were aged 16 or older.
Exclusion Criteria:
- no specific exclusion criteria
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
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
improvement/exacerbation rate of symptoms after a single session of biofield therapy
Time Frame: Up to one year after all the data were collected.
|
The Mann-Whitney test was conducted to compare the improvement/exacerbation rates between countries.
|
Up to one year after all the data were collected.
|
|
adjusted odds ratio of the factors associated with the changes in symptoms
Time Frame: Up to one year after all the data were collected.
|
Logistic regression analyses
|
Up to one year after all the data were collected.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kiyoshi Suzuki, MD, PhD, MOA Health Science Foundation
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 (Actual)
January 1, 2008
Primary Completion (Actual)
September 30, 2010
Study Completion (Actual)
September 30, 2010
Study Registration Dates
First Submitted
June 17, 2019
First Submitted That Met QC Criteria
June 19, 2019
First Posted (Actual)
June 21, 2019
Study Record Updates
Last Update Posted (Actual)
June 21, 2019
Last Update Submitted That Met QC Criteria
June 19, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOA-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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