CONSENT FORM

QIGONG INTERVENTION FOR PERSONS WITH TRIGEMINAL NEURALGIA

Researchers: Miquella Young, ASU Undergraduate in the College of Nursing and Health Innovation, BS
Integrative Health, (847)732-7983, Miquella.young@asu.edu, use as primary contact
Staff Supporter: Professor Shelby Langer, Shelby.Langer@asu.edu
Institutional Support: Arizona State University
We are asking you to be in a research study. The purpose of this consent form is to give you the
information you will need to help you decide whether to be in the study or not. Please read the form
carefully. You may ask questions about the purpose of the research, what we would ask you to do, the
possible risks and benefits, your rights as a volunteer, and anything else about the research or this form
that is not clear. When we have answered all your questions, you can decide if you want to be in the study
or not. This process is called “informed consent.” We will give you a copy of this form for your records.

PURPOSE OF THE STUDY

The purpose of this study is to examine how likely participants are to complete medical qigong sessions,
how accepting participants are of qigong, and how effective the medical qigong intervention is in treating
symptoms of trigeminal neuralgia (TN). Patients with TN have limited treatment options that are often
ineffective and highly symptomatic. Additional questions of interest are as follows: Will persons with TN
agree to participate in a qi-gong intervention? What percentage of qigong intervention sessions will
enrolled participants complete? Among those who don’t complete the intervention, what are the perceived
barriers to doing so? Will a daily medical qigong practice improve pain intensity, psychological stress,
mindfulness and quality of life among patients with TN?

STUDY PROCEDURES
The medical qigong practice involves all muscles of the body are engaged in light movement patterns.
These movements are slow-paced and deliberate. It also includes guided breathing exercises and passive
meditation. Qigong practice requires an hour-long span of time to attend to the practice, with water breaks
as needed. Restroom breaks are discouraged during the hour-long qigong session.
Qigong will be practiced in three ways: interaction with an at home video, in an organized group setting,
and on an individual basis with the qigong master and the researcher present. The at home video requires
access to a computer or a smart phone, and Wi-fi or internet connection. Transportation to and from the
group and individual meeting sites will not be provided.
1. Each video practice will remain the same. For 10 minutes you will begin with short, standing,
breathing exercise to relax the body. These include deep breaths, inhaling for four counts, holding
for four counts, and exhaling for eight counts. The next 30 minutes are spent in movement patterns
that are guided with easy-to-follow visual and auditory direction. The next five minutes are spent in
breathing exercises that will energize the body. An example of this is called bellow’s breath: the
arms reach straight up as you inhale fully and the arms come straight down to land with your
elbows by your hips and your hands in closed fists next to your shoulders while you forcefully

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 exhale. This is done for twenty breaths then there is a 30 second resting period. The twenty-breath
series is repeated three times. The last fifteen minutes are spent in silent meditation, as guided by
the words of the instructor, with the eyes closed in a comfortable seated position. It is up to your
discretion as to what to wear and where to practice at home. Lose, comfortable clothing and an
outdoor space are recommended.
2. The group and classes will follow the same pattern with a different movement routine guided by a
live instructor. It will take place outdoors in a park on the grass. Movement will be performed
barefoot if possible. The group members are advised to bring their pain journals to record their
experience after the session and to intermingle with the other participants before and after the
session.
3. Individual meetings with the qigong master will happen in the same setting as the group. These
meetings will begin with 10 minutes of deep-breathing exercises. For the next 30 minutes the
participant is guided through imagery and meditation with the master in a sitting position. The
remaining 20 minutes are utilized for questions and other conversation with the qigong master
about the practice.
Each of the three qigong exercises will be practiced once a week for one hour, totaling three hours of time
each week. This is not accounting for travel times to the group and individual sessions. It is possible for the
qigong master and researcher to organize meeting locations that are highly accessible for the participant in
the individual sessions only.
The study will run for a total of three months, with one practice a week, and daily recording of pain and
stress levels. This will total 12 hours of participation in qigong practices, not including travel and data
recording time. Pain levels will be recorded using the West-Haven Yale Multi-Dimensional Pain Inventory
(MPI). Stress levels will be recorded using the Perceived Stress Scale.
Before and after the intervention, there will be virtually organized assessments. These are available in
paper form upon request by the participant. These assessments will include the Mindful Attention
Awareness Scale (MAAS), the Short Form Health Survey, and interview.
You may refuse to answer any question or item in any test, inventory, questionnaire, or interview. You will
also be asked to keep a daily journal: logging any information you feel is necessary for you to reflect on
whether this is your pain and stress levels, new awareness, or other emotion or thought record that you
would like to share with the researchers. You are not required to write in this journal or share any private
information. These journals will be collected at the end of the session or upon request if you choose to
cease participation in the intervention.
Upon signing this form, you agree to allow the use of medical records to assert the presence of trigeminal
neuralgia and dates of significance surrounding the condition, such as instances of remission and
reappearances or increases/decreases in severity. Medical records revealing the dosages and forms of
medication prescribed by your physician will also be used to evaluate their role before and during the
intervention.

RISKS, STRESS, OR DISCOMFORT

During the intervention, participants may experience discomforts from the movement. These may include
muscle tension, muscle burning, weakness in the legs, back pain, neck pain, temporary shaking, tingling,

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and numbness. If you are not normally active, the physical risks of muscle strains, tears, or cramps is
higher.
Mental discomfort may result from the mindful engagement and long-term focused attention if this is not
something you are used to. This can result in headaches and migraines. Activity may worsen pre-existing
side-effects of TN or any other medications you may be taking. These are uncommon and likely to be short
lived.
Breathing exercises may cause chest pain, dryness of mouth, or light headedness. There are also risks in
transportation to and from the meeting sites. I, as well as Arizona State University are not liable for any
stress or discomfort that comes from this time; however, current stress level and mood will be addressed at
the beginning of each session.
Discomfort is very likely if you wear clothing that is tight or restricting. Risks of location specific symptoms
like sunburn, heat stroke, overheating, bug bites and dehydration are also present. Distresses are
encouraged to be recorded in the daily journal. However, if a serious condition presents itself, please bring
it to the immediate attention of Miquella Young, (847) 732-7983.
The recordings of qigong intervention sessions will be kept for ten years, and will be destroyed after
December 1, 2027. They will be shared with the other study participants as well as other researchers.
Videos may be used in future presentations and publications for the primary researcher Miquella Young.

ALTERNATIVES TO TAKING PART IN THIS STUDY

If the participant chooses not to participate in the intervention, resources for other local qigong studios as
well as credible on-line qigong practice videos may be provided upon request.

BENEFITS OF THE STUDY

The expected benefits of this qigong intervention are improved stress levels and knowledge of stress
management tools. Each part of the qigong practice may stand individually to reduce stress and increase
mindful awareness. The cultivation of mindful awareness may decrease pain levels and provide new tools
to cope with TN pain. Qigong practice may lessen the side effects of TN associated prescription
medications. Qigong may lead to an increase in your quality of life and reduce your stress levels. Qigong
has the potential to lessen the likelihood that surgical TN procedures are sought out. Qigong may be
practiced on an individual basis with the qigong master for one extra months past the 3-month length of the
study.
If proven efficacious, patients with TN may also have access to qigong as a form of treatment in the future.
Participation will also raise local and community level awareness of qigong as an integrative approach to
care for patients with trigeminal neuralgia, as well as other chronic illness.

CONFIDENTIALITY OF RESEARCH INFORMATION

Data will be linked to personal identifiers like age, name, and gender. This study information is unique to
the individual; although personal information like name and medical records will not be shared outside of
the research staff. The link between the participant and the study data will end ten years from now on

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December 1, 2027. Miquella Young, Arizona State University, and Professor Shelby Langer have access to
this identifiable data. Only personal data may be given to participants at the conclusion of the intervention
period.
All of the information you provide will be confidential. However, if we learn that you intend to harm yourself
or others, we must report that to the authorities .
Government or university staff sometimes review studies such as this one to make sure they are being
done safely and legally. If a review of this study takes place, your records may be examined. The
reviewers will protect your privacy. The study records will not be used to put you at legal risk of harm.
You or a member of your family can share information about yourself or your part in this research if you
wish.

There are some limits to this protection. We will voluntarily provide the information to:
 a member of the federal government who needs it in order to audit or evaluate the research;
 individuals at Arizona State University, the funding agency, and other groups involved in the
research, if they need the information to make sure the research is being done correctly

OTHER INFORMATION
You may refuse to participate and you are free to withdraw from this study at any time without penalty or
loss of benefits to which you are otherwise entitled.
Costs that the subject has to bear include transportations to and from the intervention sites.

COMPENSATION FOR INJURY

If you think you have an injury during the at-home qigong practice or otherwise related to this study, please
contact the study staff, Miquella Young at (847)732-7983 right away. She will refer you to treatment as
necessary. ASU will pay up to $10,000 to reimburse for treatment of injury or illness resulting from the
study. All other treatment will be your responsibility. No money has been set aside to pay for things like lost
wages, lost time, or pain. However, you do not waive any rights by signing this consent form.

Printed name of study staff obtaining consent Signature Date

Subject’s statement
This study has been explained to me. I volunteer to take part in this research. I have had a chance to ask
questions. If I have questions later about the research, I can ask one of the researchers listed above. If I
have questions about my rights as a research subject, I can call the Human Subjects Division at (206) 543-
0098. I give permission to the researchers to use my medical records as described in this consent form. I
will receive a copy of this consent form.

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Printed name of subject Signature of subject Date

Copies to: Researcher

Subject

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