Effect of Tao Calligraphy Meditation and Energized Water on Depression Randomized Control Cross-over Study
Phase: NA
Conditions: Unipolar Depression
Sponsor: Sha Research Foundation

1
STUDY TITLE:
Effect of Tao calligraphy Meditation and Energized Water on 
Depression
Randomized Control Cross-over Study 
PRINCIPAL RESEARCH INVESTIGATOR:
Name: Peter Hudoba, MD, FRCS
Department: Sha Research Foundation, San Francisco, California
PRINCIPAL CLINICAL INVESTIGATOR:
Name: Laurie Omuro-Yamamoto, PsyD, PhD
Satori Family Wellness Center, Maui, HI laurieoy@gmail.com
VERSION DATE:
Version 1 of 20th February 2021
RELATED STUDIES: 
None

1.0
Purpose and rationale of the study:
OBJECTIVES
The  study  is  intended  to  measure  the  effects  and  determine  the  efficacy  of  Tao
Calligraphy mindfulness practice on Depression. In our previous studies, the participants
that regularly practice have reported a decrease in symptoms of their illness as perceived
subjectively, an improvement in laboratory results or other tests and observed signs of
progress  reported  by treating  clinician  and expressed an increase  in well-being as
measured by standardized scientific questionnaires. 
HYPOTHESIS
The research hypotheses are that individuals with unipolar depression who receive
energy  transmission  (blessing)  for  their  affliction,  who  will  regularly  practice
meditations with Tao Calligraphy and drink energized water will report:
1) a decrease in the symptoms of their illness as perceived subjectively.
2) an improvement of the clinical status of their illness, as observed by their clinicians.
3) improvement of well-being or clinical status as measured by standardized scientific
questionnaire (s).
BACKGROUND
Chinese calligraphy  handwriting is a dynamic process of integrating visual spatial
awareness, cognitive planning and motor skills that is maneuvered with a brush to follow
defined configurations of characters. [1]. There has been growing empirical studies of
Chinese calligraphic handwriting that resulted in improvements in visual attention and
span, increased mental concentration [2],  confirming it as  an effective treatment for
psychosomatic conditions and post-traumatic hyperarousal symptoms [3] and exhibited
significant  effects  on  hypertension  and  type  2  diabetes  [4]  [5].  Leisure  activities
occurring later in life that includes calligraphy may inhibit cognitive decline [6].
Tao Calligraphy is a unique branch of Chinese calligraphy (Yi Bi Zi) in that it is
characteristic of one stroke writing. Every character is written with one continuous
stroke  with  the  brush always  in  contact  with the  paper.  [7] Results  from  studies
confirmed efficacy in tracing in post-acute rehabilitation setting in that patients reported
being less incontinence, shortened duration of hospital stay, an increase in overall well-
being. [8] Retrospective analysis of data exhibited improvement in general wellbeing, an
increase in optimism and energy level, as well as improvement of their symptoms. [9]
According to a study measuring the effects of calligraphy tracing meditation with mantra
chanting (repeated sound or word to aid with concentration saying out loud or silently)
of spiritual  practitioners, the results  exhibited  statistically  positive improvement  in
Physical  Functioning,  Role  Limitations  due  to  physical  health  problems;  Role
Limitations due to Personal or Emotional Problems; Energy / Fatigue; Emotional Well-
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being; Social Functioning; Bodily Pain; General Health. [10] In the prospective follow
up study of these subjects, following 6 months they continued to improve in functioning
in the above-mentioned areas. The authors concluded that tracing calligraphy and mantra
chanting was simple to follow, well tolerated and no complications arose during the
study. [11]
Medical conditions, life threatening diseases, degenerative illness and mental health
challenges impairs functioning that interfere with activities of daily life, and negatively
impacts overall well-being. Current studies suggest that life expectancy of an individual
decreases with each additional chronic condition. [12] Individuals diagnosed with major
depressive disorder are susceptible for cardiovascular disease and stroke. [13] Following
a heart attack, people experiencing depression increases their risk for cardiac-related
death  three-fold.  Also,  diabetes  doubles  the  risk  for  depression.  [14]  Well-being
incorporates mental health (mind) and physical health (body) that results in more holistic
interventions  for  disease  prevention  and  health  promotion.  [15]  Cross-sectional,
longitudinal and experimental studies indicate that well-being is associated with,  Self-
perceived health, Longevity, Healthy behaviors, Mental and physical illness, Social
inter-connectedness, Productivity and Factors in the physical and social environment.
[16] [17]
2.0
RATIONALE 
The study aims to acquire both basic and applied knowledge to which the primary
purpose is gain the measurable data of individuals with various illnesses to meditation
with Tao Calligraphy, specifically focused on the alleviation of their condition. Thus,
proposing  another  method  of  rehabilitation  that  would  be  integrated  into  their
conventional medical treatment and care. 
THEORETICAL FRAMEWORK
Tao Calligraphy art has been studied in the US and Canada since 2013, producing
significant results in improving overall well-being and an efficacious intervention for
individuals with chronic conditions. This is a unique style of moving meditation, where
mindfulness (heightened awareness) is achieved by the combination of movement and
focus on Calligraphy art. In this practice, the subjects trace the lines of calligraphy with
fingers and simultaneously say loudly or silently an affirmation (mantra), which enables
them to achieve deep concentration  during wakefulness. The proposed research to
measure the effects of Tao Calligraphy will further provide collective data to offer an
integrative intervention for individuals seeking additional treatment that is of minimal
risk and to maximize benefits to address condition. 
The proposed research is focused on the effects of transmission of pure energy (blessing)
and meditation on humans with a specific illness or health condition. 
This study is a fully developed project, based on experiential data obtained from several
previous pilot and formal studies.
3

The soul healing techniques of the Power Healing system were evaluated in a “Cancer
Recovery Pilot Study” conducted from November 1, 2000 to February 14, 2001. This
study was led by Master Sha and John Gray, and Elizabeth Targ MD as a director. It was
approved  by  the  internal  board  of  the  Complementary  Medical  Research  Institute
(CMRI) and the California Pacific Medical Center (CPMC), San Francisco. This study
employed Western psychological techniques with Eastern energy balancing techniques.
An analysis of the data from the Pilot Study confirmed the validity and efficacy of Zhi
Neng Medicine and Power Healing techniques in the treatment of cancer. A statistically
significant  improvement  of  Karnofsky  and  EORTC  scores  was  observed  upon
completion of the three-month program.
The  effect  of  Zhi  Gang  Sha’s  transmission  of  a  pure energy  (blessing)  was  also
evaluated in the “Change of the Heart Double Blind Randomized Crossover Study”
conducted from August 15 to October 10, 2005. 
This study was approved by the internal board of Sha Research Foundation in San
Francisco The initial results of the study confirmed that it is possible to measure the
effects of a long-distance blessing on the energy and spiritual systems of recipients.
Some of the changes measured were statistically significant. Analysis of data from the
study showed statistically significant improvements in empathy, egotism, mental and
emotional well-being, and the quality of meditative states. Some (but not all) remote
viewers were able to document changes in the spiritual images, producing statistically
significant differences between blessed and control groups. Regression analysis showed
dependency on the length and depth of the spiritual practice of subjects.
The effects of Zhi Gang Sha’s transmission of pure energy (blessing) and meditations
were also evaluated in the “Miracle Healing Case Studies,” conducted from November
2013 to November 2016 (Level 1) and from 2017 until 2021 (Level2) and from 2019
until now (Level 3). 
These studies were approved by IRB at Aurora, ON, Canada. The Level 1 study was
completed successfully and most of the subjects who did participate in the study until its
conclusion  reported  marked  reduction  of  symptoms  and  no  side  effects  from  the
practices. The results were presented at several conferences in the USA. In Level 2
study, the subjects reported marked reduction of symptoms and no side effects from the
practices. Statistical analysis of the research questionnaire was significantly positive.
The results were presented at several conferences in the USA. The subjects in Level 3
study  also  reported  marked  reduction  of  symptoms  and  no  side  effects  from  the
practices. Statistical analysis of the research questionnaire was significantly positive.
The results were submitted for presentation at upcoming conference in the USA.
 
No risks or negative side effects of the transmission of pure energy given to human
participants  or meditation with Tao Calligraphy have been observed in these pilot
projects and formal studies.
For the list of Research Presentations please refer to Appendix A.
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METHOD
This study will determine  the effects  of transmission of a pure energy (blessing),
meditation with Tao Calligraphy and drinking energized water as measured through
subjective and objective evaluations of changes in depression in the subjects.
Design of the Study
The study will be performed as a Randomized Controlled Cross-over Trial. 
New subjects may enter the study at any time. After new subjects are admitted into the
study, they will be randomized into either the treatment or the control group. 
All subjects that are randomized into the control group will be observed only (without
doing any practice) during the 1st six weeks. They will then be switched into the
treatment group, will receive a transmission of a pure energy (blessing) and will be
practicing Tao meditation, and drinking energized water daily for the 2nd  six weeks.
All subjects that are randomized into the treatment group will receive a transmission
(blessing) and will be practicing Tao meditation and drinking energized water daily
during the 1st six weeks. They will then be switched into the control group and will be
asked to stop any meditation for the 2nd six weeks.
Every subject who is accepted into the study, will receive transmission (blessing) by Zhi
Gang Sha (or his designee) prior to the commencing  meditation  practice,  will be
instructed on how to practice meditations with Tao Calligraphy and how to energize the
water they will drink.
New subjects may enter the study at any time. After new subjects are admitted into the
study, they will be randomized into either the treatment or the control group and
analyzed at monthly regular intervals for two months. 
Data collection: 
Participants in both control and treatment group will complete the questionnaire (s) at
the entry time point (Time 0), at the end of 1st six weeks (Time 1), and at the end of 2nd
six weeks (Time 2).
Every subject who is accepted into the study, will receive prior to the inception of
practice transmission of pure energy (blessing) and will be instructed on how to practice
meditations with Tao Calligraphy, how to energize the water during this practice and to
drink it.
This study will evaluate the effects of the transmission of pure energy (blessing),
meditation with Tao Calligraphy and drinking energized water as follows: 
The study is conducted on an outpatient basis and includes:
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-
a telephone discussion (clarification of inclusion / exclusion criteria) 
-
signing of the consent /Information; instruction in the study design and practicing
the Tao Calligraphy-tracing meditation and energized water drinking; first data 
collection questionnaires (Time 0)
-
regular weekly meditation practices on Zoom with participants in the treatment 
arm
-
Completion of the questionnaires by the participants at Time 1 (6 weeks) and 
Time 2 (at 12 weeks) 
-
Completion of assessments by a Study principal co-investigator 
B)  Improvement  of  general  well-being  or  clinical  well-being  as  measured  by
standardized questionnaires (in 6 weeks intervals). 
These questionnaires will be used in the study:
1. John Ware’s SF-36 Quality of Life questionnaire
2. PHQ9 Depressive Symptoms (Psychometric questionnaire)
3. BAI-21 Beckman Inventory (Psychometric questionnaire)
All participants will complete the first questionnaire Quality of Life (SF36), PHQ9 
Depressive Symptoms and BAI-21 Beckman Inventory upon entry into the study (Time 
0) and then again after first 6 weeks (Time 1) and again after second 6 weeks ( Time 2 - 
the end of participation in the study).
Transmission of pure energy and instruction of subjects on how to practice meditations
with Tao Calligraphy and drinking energized water will be the sole responsibility of
Universal Soul Service Corp.
Collection,  handling,  and  evaluation  of  medical  records  and  questionnaires  and
presentation of the research results will be the sole responsibility of Sha Research
Foundation. 
Study Execution
The study will be performed by collecting enrollment data and medical data directly
from patients personally, over the phone, via email or on-line (Zoom). The research
Questionnaires will be filled on-line using personal ID Codes – to ensure confidentiality.
The codes will be emailed by the PI to each of the participants individually.
The transmission of the  blessing will be conducted by Tao Academy team, who will
offer the blessing to subjects of the study remotely. 
Tao Academy team will be responsible for teaching subjects the meditation with Tao
Calligraphy.
The transmission of pure energy (blessing) will be done to participants for free by Tao
Academy certified teacher. There will be no fees for the teaching on how to meditate nor
for any other aspect of participation in the study. 
A copy of Tao Calligraphy Greatest Love by Dr. Zhi Gang Sha will be provided
electronically. 
6

Conversely, participants will receive no remuneration for participating in the study.
Data collection, data handling, and data assessment will be the responsibility of the Sha
Research Foundation’s research team members who have a medical, nursing, and/or
scientific background, and will be performed through personal delivery, by email and
online collection.
Members of the research team will NOT administer any transmission of pure energy
(blessing), teaching, or any form of medical support to participants of the study.
Participants of the study will be required to self-meditate using the Tao Calligraphy for
thirty minutes every day and to record the length of practice and responses during and
after each practice. They will also energize a 1 L of regular drinking water using this
practice and will drink it over the course of the day to their leisure. Besides individual
meditations on their own, participants will attend once a week 30 min long group
meditation practice led by an Instructor, done over the Zoom.
Meditation with Tao Calligraphy instruction sheet and instruction how to energize the
water will be provided to the participants. Participants will be responsible for obtaining
their drinking water (either tap water or bottled water).
Process for energizing the water: Subjects will obtain 1 L bottle of their choice to which
a one-time transmission of a pure energy will be given at the same time as they are
receiving energy transmission to facilitate their meditation practice. Participants will fill
the bottle daily with the drinking water (tap or purchased bottled water)  before starting
their meditation. At the beginning of meditation practice, the subject will ask to have the
water energized by their meditation practice. After the meditation practice, they will
drink the water throughout the day.
Subjects  in  the  study  should  continue  to  follow  their  physicians’  advice  and
recommendations during their participation in the study and should continue to receive
any, and all conventional treatment in which they have been participating prior to entry
into this study.
 
Sha Research Foundation will clearly inform participants that the teaching and research
teams are not offering any medical diagnosis, guidance, evaluation, or treatment and that
participation in the study is not a replacement for any conventional medical treatments
or diagnosis.
Participants are also encouraged to continue their usual spiritual practices in which they
have been participating prior to the study.
Participants of the study will be responsible for obtaining copies of their medical records
from their medical practitioners and delivering them to Foundation officers.
The study will commence in 2021 and will last for about 3 years. The plan is to accept
new subjects into the study at any time from its commencement in 2021 up to 3
September of 2024 – with expected conclusion in December of 2024.
7

There is no limit to the number of subjects that may be admitted to this study during the
study years. Subjects can withdraw from the study with no penalty at any time for
whatever reasons they may have.
3.0
Enrollment Criteria (who can be in your study and who would not
be eligible to participate in your study):
Patient Population
1. Subjects with diagnosed Unipolar Depression an Improvement of Depression 
symptoms when practicing Tao calligraphy tracing meditation and drinking 
energized water.
2. Improves the quality of life and well-being of unipolar depressive Subjects 
through regular Tao calligraphy tracing meditation and drinking energized water.
Inclusion criteria
-
Adult subjects / patients (age 19 years and over) with a primary diagnosis as one
Unipolar depression according to ICD-10 criteria is present and diagnosed by a
licensed physician. 
-
Disease duration at least six months. 
-
Willingness and ability to comply with data collection requirements. 
-
Complete submission of required documentation prior to enrollment into the study,
including informed consent and consent to release of information.
-
Willingness to allow their data to be used for research purposes and published as
deemed fit (while conforming to all applicable privacy laws) by Sha Research
Foundation.
-
Willingness to practice the daily calligraphy meditations and follow the protocol.
Exclusion criteria
- Not meeting any of the inclusion criteria
- Bipolar disorders, schizophrenia (psychosis)
- Treatment with highly potent neuroleptics
- inability to sign consent and follow instructions
- Acute suicidality, suicide plans or suicide attempts in the current disease episode or 
suicide attempt within the last 3 years
- Unwillingness to participate in data gathering
- Unable to follow the practice regimen, including the daily calligraphy meditations
- Pregnant or nursing. Participants who become pregnant during the study will be required
to end their participation.
- Serious mental disorders (e.g., schizophrenia)
- There are no exclusion criteria placed upon potential subjects related to national origin,
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culture, ethnicity, race, sex, physical disability, sexual orientation, religion, or spiritual
practices.
4.0
Sample Size:
A/ Sample Size: 
The study will be conducted as a randomized controlled trial. It will Subjects / patients 
who are between 19 and 63 years old at the time of the examination, with clinically 
relevant and unipolar depression (according to ICD-10, 2015) in two groups divided 
randomly.
The number of cases calculated was N = 55 (rounded up to 56) for both groups with one 
calculated drop-out rate of 15%, calculated. Here, the two-sample (two-sample) t-test 
applied.
1  st   six weeks:
 
 
Assuming a symptom reduction of 30% in group I and 0% in group II and a standard 
deviation of 30%, you need 90% power 23 patients per group, for a total of N = 46.
2  nd   six weeks:
 
 
The same number of cases results after the second month. If one goes from one Symptom 
reduction of 60% in group I and 30% in group II and one Standard deviation of 30%, with
a power of 90% you need 23 patients per Group, that is a total of N = 46.
Taking into account a drop-out rate of 15%, in both cases N = 55 (rounded up to 56) 
patients needed.
Group I: 
Tao calligraphy mediation group I (number 28)
Group II: 
Control Group II (number 28)
The evaluation of Quality of Life and Psychometric questionnaires is done by means of
the program PSPP using appropriate parametric and non-parametric tests: For statistical
analysis of scores obtained from questionnaires we will use Anova, two-way Anova and
regression analysis, we set confidence level at 95%.
The results of the study will be published on the Foundation website and on the scientific
meetings and journals. The audience is expected to be the health care, scientific, and
integrative, complementary, and alternative medicine communities.
The data and results  of the study remain the intellectual property of Sha Research
Foundation. 
Authorship of the data of this study will be based on:
1. degree of contribution to the conception or design of the study
2. degree of creating any important intellectual content of the study
3. degree of participation on creating final report
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4. an agreed role in the conduct of the study.
5.0
Recruitment and Screening Methods:
Recruitment announcement with be placed at:
Sha research foundation website: www.ShaResearchFoundation.
 
 com
 
 
Sha Research Foundation Twitter and Facebook
Social media Depression Support groups 
Letters in selected psychiatric and psychologist offices
Advertisement in newspaper and magazines. 
We are submitting previously approved letter and advertisement for the study 
Pro00031067.
SCREENING METHODS:
1) Diagnosis must be made by a licensed medical professional - a specialist in the field,
outlined in a formal medical letter with clinical symptoms, signs, and results of tests at
the time diagnosis was made.   
2) Medical reports as applicable to the given illness, at the time diagnosis was made.
3) Research data by standardized questionnaire collected at the time of entry to study and
at the times of 6-week follow up intervals.
6.0
Research Locations:
Satori Family Wellness Center 339 Kalua Road, Wailuku, HI 9679 Phone: 808.205.6637  
7.0
Multi-site Research (research that involves external collaborating 
institutions and individuals): 
N/A
8.0
International Research (where data collection will occur outside the
United States and U.S. territories, including online activities)
The research will take place in the U.S.A and Canada only.
9.0
Procedures Involved:
The study is conducted on an outpatient basis and includes:

A personal or telephone discussion (clarification of inclusion / exclusion criteria) 
signing of the consent /Information; 
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
instruction in the study design and practicing the Tao Calligraphy-tracing 
meditation and energized water drinking; 

first data collection questionnaires at Time 0

randomization into intervention and control groups

regular Zoom practices with participants in the intervention group (or pre-recorded
meditation practices with certified teachers as a back-up)

Completion of the questionnaires by the participants at Time 1 (6 weeks) 

Cross-over after completion of 1st six weeks (intervention group becomes a control
group, and control group becomes intervention group)

Completion of the questionnaires by the participants at Time 2 (at 12 weeks) 

Completion of assessments by a Study principal co-investigator 
Procedures to protect subjects who are found to be at risk of self-harm during the study: 
a.
All subject will be required continue their conventional medical treatment and 
support with their health care providers.
b.
Subjects will be notified during initial interview that the participation in the study 
does not offer any diagnosis and does not replace convention treatment.
c.
We require that the participants continue to be under the medical supervision of 
their health care providers.
d.
Clinical PI is licenced psychologist in the USA who will be reviewing the 
questionnaires right after they were filled up to identify if the results do not 
represent a risk of suicide in the subjects
e.
At the time of screening participants will be given the phone number to the clinical
investigator where they can call in the time of distress.
10.0
Research with Vulnerable Populations (if children are the ONLY 
vulnerable population you plan to enroll, do NOT complete this 
section -- instead fill out Appendix A)
N/A
11.0
Incomplete Disclosure or Deception:
N/A
12.0
Consent Process: 
Trained research team member(s) will follow SRF Consent process V1.0 20200306. 
After obtaining the name and contact of potential participant from the PI, research team 
member will connect with the potential subjects for screening using inclusion and 
11

exclusion criteria of the study. This will be done either in person, over the phone or Zoom 
meeting. If the consent is done by the phone-call or Zoom, signature will be issues on 
behalf of the participant by the consenting research team member and witnessed by a 
second person. Participant will be given a copy of the consent form and a study 
information letter for the participants, explaining the study in more detail.
For consent form see Main ICF.
The signed consent will be sent to and stored at Sha Research Foundation for 7 years. 
13.0
Waiver of Participant Signature on Consent Form:
We would like to apply for a waiver of documentation of consent for verbal consent so 
that consent can be obtained remotely.
14.0
Waivers and Alterations of Consent Information:
N/A
15.0
Financial Compensation:
There will be no compensation of research participants.  
Participants may incur cost related to copying or faxing documents.
Participants will receive free instructions and weekly practices with instructor.
Participants will receive free transmission of pure energy (blessing).
Research involves Minimal Risk to the participants; therefore, no compensation will be 
available to the participants.
16.0
Audio/Video Recording/Photography
We will not be performing any video, audio or photography recording. 
17.0
Potential Benefits of this Research: 
There has been growing empirical studies of Chinese calligraphic handwriting that resulted 
in improvements in visual attention and span, increased mental concentration, confirming 
as an effective treatment for psychosomatic conditions and post-traumatic hyper-arousal 
symptoms, and exhibited significant effects on hypertension and type 2 diabetes. Leisure 
activities occurring later in life that includes calligraphy may inhibit cognitive decline. 
Our own studies clearly documented improvement in Wellbeing Scores (Rand SF-36 
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questionnaire), improvement in pain scores (McGill pain questionnaire) in subject suffering
from chronic pain. Improvement in depression scores (BDI, PHQ9 and HAM 
questionnaires) in patient with depression. Wellbeing and pain study has been already 
presented at the conference. Depression study (from Germany) was recently submitted for 
presentation.
18.0
Potential Risks to Participants:
No risks or negative side effects of the blessings given to human participants or calligraphy
meditation with Tao Calligraphy have been observed in our pilot projects and formal studies.
19.0
Provisions to Protect Participant Privacy and Data Confidentiality:
All scientific data will be stored in the computer in spreadsheet under ID code numbers 
according to Tri Council Policy Statement: Ethical Conduct for Research Involving Humans 
(2005). 
A unique ID code number will be assigned to each participant for entry for internal tracking. 
Once the unique ID number is assigned, no personal identity information is kept with research 
spreadsheets.
The data collected via website will have only confidential ID assigned and never any names or
personal identifiers. As there are no names associated with participants’ responses in their 
electronic research files, it would be impossible to know which subject these responses belong 
to.
When client provides medical or personal information in paper form, these are scanned and 
forwarded to research team by email. Paper original documents are returned to participant who
provided them. Once the email with documents is received by research team, downloaded to 
research external hard drive, and confirmed receipt, the emails with files are deleted from 
email inbox.  
All collected personal and medical information is stored on external hard drive that can be 
accessed only through a password-protected Linux-based program. 
There will be no hard copies of data printed out, although the results of statistical tests and 
actual papers for presentation will be in paper form.
20.0
Data Monitoring Plan to Ensure the Safety of Participants:
The collected data will remain the property of Sha Research Foundation and only members of
the research team will have the access to the research data collected.
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Each participant will complete an Application Form. The signed consent forms will be faxed
to the Foundation.  Data collection will be executed at 6-week intervals after receiving the
energy transmission for total of 3 months.
Research Data
At the time of admission to the study, participants will provide following:
1) Copies of their medical records that must include a medical letter from their physician or
specialist documenting the onset of their illness, symptoms, and signs, results of all relevant
tests, medical procedures, and medications, and progress of the illness, at or soon after the
transmission of blessing by Zhi Gang Sha (or his designee), and then again when new relevant
information arises. 
2) Participants will as well provide a letter with their subjective description of symptoms prior
to the incept of Tao calligraphy meditation practice.
3) Participants will complete following research questionnaires prior to the incept of Tao 
calligraphy meditation practice, transmission of pure energy (blessing) and drinking energized 
water: Rand Quality of Life (SF36), PHQ9 Depressive Symptoms, BAI-21 Beckman 
Inventory.
4) During the time of the study, participants will provide the following:
A) The medical letter from their physician or specialist documenting any change of their
illness, symptoms, and signs, results of all relevant tests, medical procedures, and medications
at any time when new relevant information arises. 
B) Follow up research questionnaire (our design - Form 5), Rand Quality of Life (SF36),
PHQ9 Depressive Symptoms, BAI-21 Beckman Inventory filled at six weeks (Time 1) and 12
weeks (Time 2) follow ups.
Standardized research questionnaires are collected at the time of entry to the study and at the
times of six weeks follow up intervals, together for 3 months.
C) Data Processes
There will a Consent Process form filled after consenting procedure, this will be reviewed.
All applications are audited for completion.
The log of adverse events will be maintained (this would include data issues also).
The other logs would be: Protocol deviation Log, Subject withdrawal and termination log,
Subject visit log spreadsheet, Telephone log.
Application, consent and any medical documents will be scanned and stored on large (not
flash drive) external drive by principal investigator. After he confirms receipt, any person
obtaining these documents will delete them from their computers and from email inbox. Once
principal investigator downloads the data from inbox to a hard drive, any email containing
data will be deleted from the inbox. 
Research Data collected on password protected entry on the website, will have only first name
14

and confidential ID as identifiers, and so even in unlikely event of breach to website, no
research data could be attributable to a particular person.
All data will be stored for 7 years and will be safely deleted afterwards. Any retiring hard
drive will be not only erased, but also physically damaged so could not be read from anymore
(in accordance to Canadian Medical Protective Association guidelines).
21.0
Long-term Data and Specimen Storage and Sharing: 
All scientific data will be stored on external hard drive at least 7 years under ID code numbers 
according to Tri Council Policy Statement: Ethical Conduct for Research Involving Humans 
(2005) and HIPAA. All data will be deleted after 7 years.
No personal or attributable medical data will be shared outside of Sha Research Foundation.
22.0
Qualifications of Research Team to Conduct the Research:
Peter Hudoba, MD, FRCS, neurosurgeon, affiliated as researcher with, and prior CEO of Sha 
Research Foundation. Previously as a Professor of Neurosurgery, University of Saskatchewan. 
Mailing address: Mt Seymour Clinic, 2nd Floor, 333 Mt Seymour Boulevard, North Vancouver, 
BC 
Laurie Omuro-Yamamoto PhD, Licensed Psychologist: Satori Family Wellness Center 339 
Kalua Road, Wailuku, HI 9679 Phone: 808.205.6637   laurieoy@gmail.com
Marie-Louise Zurbach: retired medical laboratory technician; quality assurance auditor, Quebec,
Canada
Rya Joy  Baligad: Physiotherapist, Maui HI, U.S.A.
Anette Omuro: certified Tao academy teacher, Maui HI, U.S.A.
Nishat Kazi student of psychology with extensive experience in psychology research. 
University of Toronto, Toronto, Canada
15

Appendices and additional documents:
Appendix A: SRF Research Conferences Presentations 2001-2021
Appendix B: References
Appendix C: CVs
Informed Consent Form
Information Letter to Subjects
Rand SF 36 Questionnaire
PHQ9 Depressive Symptoms 
BAI-21 Beckman Inventory
______________________
 __________________ 
Allan Chuck
         
    Date
President and CEO
Sha Research Foundation
______________________
 __________________ 
Peter Hudoba
      
    
   Date
Principal Research Investigator
16