Clinical trial NCT03994809: International Study of Biofield Therapy
Official title: International Cross-sectional Study on the Effectiveness of Biofield Therapy for the Relief of Various Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Depression, Anxiety
Dizziness
Signs and Symptoms
Keywords: biofield therapy
ethnic differences
Okada Purifying Therapy
effectiveness
safety
Lead sponsor: MOA Health Science Foundation
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 12000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: improvement/exacerbation rate of symptoms after a single session of biofield therapy
timeFrame: Up to one year after all the data were collected.
measure: adjusted odds ratio of the factors associated with the changes in symptoms
timeFrame: Up to one year after all the data were collected.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MOA Health Science Foundation
name: Kiyoshi Suzuki, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.