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International Study of Biofield Therapy

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ClinicalTrials.gov Identifier: NCT03994809
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Kiyoshi Suzuki, MOA Health Science Foundation

Tracking Information
First Submitted Date June 17, 2019
First Posted Date June 21, 2019
Last Update Posted Date June 21, 2019
Actual Study Start Date January 1, 2008
Actual Primary Completion Date September 30, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2019)
  • 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.
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Study of Biofield Therapy
Official Title International Cross-sectional Study on the Effectiveness of Biofield Therapy for the Relief of Various Symptoms
Brief Summary 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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Pain
  • Depression, Anxiety
  • Dizziness
  • Signs and Symptoms
Intervention Other: Okada Purifying Therapy
The practitioner raises his/her hand forward towards the recipient with the palm directed toward the recipient. The practitioner uses his/her hands alternately during the administration of Okada Purifying Therapy. The distance between the palm and the body is usually 1-2 feet, with each session typically lasting 30 to 60 minutes.
Study Groups/Cohorts Not Provided
Publications * Suzuki K, Uchida S, Kimura T, Tanaka H, Katamura H. International Cross-Sectional Study on the Effectiveness of Okada Purifying Therapy, a Biofield Therapy, for the Relief of Various Symptoms. J Altern Complement Med. 2020 Jun 17. doi: 10.1089/acm.2019.0264. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 19, 2019)
12000
Original Actual Enrollment Same as current
Actual Study Completion Date September 30, 2010
Actual Primary Completion Date September 30, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Individuals who agreed to receive a single session of biofield therapy for 30 minutes or longer from the volunteer investigators.
  2. Individuals who were able to self-evaluate the change of their symptoms.
  3. Individuals who were competent to answer the questionnaires.
  4. Individuals who were aged 16 or older.

Exclusion Criteria:

  • no specific exclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03994809
Other Study ID Numbers MOA-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kiyoshi Suzuki, MOA Health Science Foundation
Study Sponsor MOA Health Science Foundation
Collaborators Not Provided
Investigators
Study Chair: Kiyoshi Suzuki, MD, PhD MOA Health Science Foundation
PRS Account MOA Health Science Foundation
Verification Date June 2019