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出境医 / 临床实验 / International Study of Biofield Therapy
International Study of Biofield Therapy
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Pain Depression, Anxiety Dizziness Signs and Symptoms | Other: Okada Purifying Therapy |
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 Design
| Study Type : | Observational |
| Actual Enrollment : | 12000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | International Cross-sectional Study on the Effectiveness of Biofield Therapy for the Relief of Various Symptoms |
| Actual Study Start Date : | January 1, 2008 |
| Actual Primary Completion Date : | September 30, 2010 |
| Actual Study Completion Date : | September 30, 2010 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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
Eligibility Criteria
Contacts and Locations
| 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 |
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| 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 |
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| 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 |
|
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| 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.
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| 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 Aug;26(8):708-720. doi: 10.1089/acm.2019.0264. Epub 2020 Jun 17. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Kiyoshi Suzuki, MOA Health Science Foundation | ||||
| Study Sponsor | MOA Health Science Foundation | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | MOA Health Science Foundation | ||||
| Verification Date | June 2019 | ||||
