PainNCT03994809
International Study of Biofield Therapy
An observational study of Pain and Depression, Anxiety, run by MOA Health Science Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Depression, Anxiety, Dizziness
- What is being tested?
- Okada Purifying Therapy
- How many people
- 12,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 30 Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants were recruited in various settings, including the workshop, the investigator's house, or the participant's home in 14 different countries.
Who may be able to join
- 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.
Who cannot join
- no specific exclusion criteria
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Depression, Anxiety, Dizziness, Signs and Symptoms
- Being tested
- Okada Purifying Therapy
- Keywords
- biofield therapy, ethnic differences, Okada Purifying Therapy, effectiveness, safety
- Medical subject headings
- Pain, Depression, Anxiety Disorders, Dizziness, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Okada Purifying TherapyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement/exacerbation rate of symptoms after a single session of biofield therapy
The Mann-Whitney test was conducted to compare the improvement/exacerbation rates between countries.
Measured: Up to one year after all the data were collected.
adjusted odds ratio of the factors associated with the changes in symptoms
Logistic regression analyses
Measured: Up to one year after all the data were collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Jan 2008
- Primary completion30 Sep 2010
- Study completion30 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- MOA Health Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiyoshi Suzuki, MOA Health Science Foundation
- Investigators
- Kiyoshi Suzuki, MD, PhD, Study chair, MOA Health Science Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994809
- Sponsor's protocol ID
- MOA-004
- Status last verified
- Jun 2019
- First submitted
- 17 Jun 2019
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32551797
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Cross-sectional Study on the Effectiveness of Biofield Therapy for the Relief of Various Symptoms
- ClinicalTrials.gov ID
- NCT03994809
- Acronym / sponsor ID
- MOA-004
- Conditions
- Pain, Depression, Anxiety, Dizziness, Signs and Symptoms
- Keywords
- biofield therapy, ethnic differences, Okada Purifying Therapy, effectiveness, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- MOA Health Science FoundationUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 30 Sep 2010 (actual)
- Study completion
- 30 Sep 2010 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were recruited in various settings, including the workshop, the investigator's house, or the participant's home in 14 different countries.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Okada Purifying TherapyThe 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Derived from this study: PubMed 32551797Suzuki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiyoshi Suzuki, MD, PhD study chair
MOA Health Science Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Depression, Anxiety, run by MOA Health Science Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03994809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.