Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
Phase: NA
Conditions: Chronic Pain, Musculoskeletal Pain
Sponsor: Palo Alto Veterans Institute for Research

 
 
 
 
 
 
 
 
Feasibility of at Home Telehealth Yoga for Treating Chronic Pain 
 
 
 
Study Protocol and Statistical Analysis Plan  
 
 
 
NCT #: 04074109 
 
 
 
November 22, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background 
Chronic pain is a debilitating condition with high societal and economic costs. 
Pharmacological pain management includes opioids, which can be dangerous and ineffective 
after long-term use. Consequently, increased efforts are being made to find nonpharmacological 
treatment options for the management of chronic pain. For this reason, rigorous research on 
complementary and integrative health (CIH) for pain is a top priority and pain is the condition 
for which adults in the United States most often use complementary and integrative health. 
Chronic pain, and especially musculoskeletal pain is even more prevalent among veterans, and 
yoga has emerged as a popular and effective treatment option. The use of yoga to treat chronic 
pain has been endorsed by many organizations including the NIH, the American College of 
Physicians, and the VA. However, patients, especially rural and low-income patients, can 
encounter many barriers to practicing yoga, including travel costs and time, health conditions, 
bad weather, lack of transportation, and family responsibilities. One solution to overcome these 
barriers is to provide yoga at home using internet-based technology ("teleyoga"). Indeed, the 
provision of VA care via telehealth to increase access to those living far from VA medical 
facilities is a VA priority. Teleyoga is an innovative, potentially effective approach for treating 
chronic pain in veterans. Research evaluating the acceptability or efficacy of teleyoga is very 
limited. Our pilot data indicate that teleyoga is safe and has similar efficacy to in-person yoga for 
treating several common conditions in veterans, including chronic musculoskeletal pain (Schulz 
Heik et al., 2017). However, our teleyoga experience is limited to group yoga instruction via an 
audiovisual link to one or more outpatient clinics. This clinic-based modality requires 
participants to travel to a clinic for yoga instruction and does not overcome the multiple barriers 
associated with in-person care. Attempts by other groups to deliver at-home teleyoga have not 
overcome all the technical barriers encountered (Donesky et al., 2017). Standard Video 
conferencing software offers an exciting opportunity to develop at-home teleyoga using a well-
resourced, scalable, and technologically advanced system. This study will focus on the treatment 
of chronic musculoskeletal pain, as it is the most common type of chronic pain in veterans and 
nonveterans (Kerns, 2018) and responds well to yoga. 
 
Objectives 
The primary objective is to test the feasibility of treating chronic pain with yoga delivered 
via telehealth. We will modify an existing yoga intervention for chronic musculoskeletal pain 
and address the technical challenges of at-home teleyoga. Then, using the modified intervention, 
we will demonstrate the feasibility of conducting a randomized controlled trial involving at-
home teleyoga. 
 
Specific Aims and Hypothesis 
 
Specific Aims:  
1. Modify an existing yoga intervention for chronic musculoskeletal pain and address the 
technical challenges of at-home teleyoga.  
2. Demonstrate the feasibility of conducting a randomized controlled trial involving at-home 
teleyoga. 
 

Hypothesis 1 (primary): a) Treatment satisfaction as measured by the Multi-Dimensional 
Treatment Satisfaction Measure will be neutral or positive for all factors. B) Treatment 
satisfaction will be at least neutral for all items.  
Hypothesis 2 (secondary): a) It will be feasible to recruit 30 participants over a 3-month period 
and deliver yoga in-person or via at-home teleyoga while maintaining a retention rate 
commensurate with other similar studies. b) Fidelity of treatment delivery will be acceptable as 
measured by scoring of taped sessions. c) We expect participants will complete the PROMIS 
measures with a missing data rate not to exceed 15% per participant. d) The yoga intervention 
will be safe with no serious adverse events in either treatment group. 
 
Study Design  
This study aims to investigate the feasibility of at-home teleyoga for veterans with 
chronic musculoskeletal pain. We will demonstrate the feasibility of conducting a randomized 
controlled trial involving at-home teleyoga. We will randomize veterans (N=30) with chronic 
musculoskeletal pain to at-home teleyoga or in-person yoga. Primary feasibility outcomes will 
include recruitment rates, retention, protocol adherence, participant satisfaction from semi-
structured questionnaires, adverse events, treatment fidelity, and rates of completion of study 
instruments. Feasibility will be determined by comparison to benchmarks from studies that used 
similar interventions and populations. 
We intend to recruit local (residing in the San Francisco Bay Area), outpatient adult 
veterans with chronic musculoskeletal pain to enroll in this clinical trial. This research proposal 
will use randomization after baseline assessments to assign participants (n=30) to at-home 
teleyoga or in-person yoga (n=15 per group). Randomization will occur by identifying group 
membership in 30 sealed envelopes and having each participant draw one envelope. To be 
representative of the veteran population at VAPAHCS Health Care System (VAPAHCS) each 
group will have 1-2 females. 
All human subjects research will be performed at VAPAHCS in Palo Alto, California or 
at the homes of the veterans (residing in the San Francisco Bay Area) who receive the at-home 
teleyoga group. There are no other collaborating sites where human subjects research will be 
performed.  
 
Month 
1 
2 
3 
4 
5 
6 
Recruit (n=30) 
Run in-person yoga groups (n=15) 
Run at-home teleyoga groups (n=15) 
Table 1. Recruitment Table 
 
Group assignment and randomization 
Eligible participants will be added to a cohort list; when 30 have been identified, the 
study team will schedule baseline assessments. After the baseline assessments, participants will 
be randomized to in-person or at-home teleyoga (n=15 per group). Randomization will occur by 
identifying group membership in 30 sealed envelopes and having each participant draw one 
envelope. Each group will contain 1-2 females, to be representative of the veteran population at 
VAPAHCS.  
 
Statistical Plan and Data Analysis  

 
Fidelity and Missing Data Benchmarks 
Fidelity: The instructors will review the video recorded sessions using a manual checklist for 
instructor adherence to the yoga manuals, which will consist of a Yes/No for each procedure or 
instruction.  
Missing Data: Like similar behavioral outcome measures, we expect missing data in the 
PROMIS-PI measures not to exceed 15%. 
 
The main analytic strategy will be descriptive statistics at pre- and post-intervention 
assessments in each arm. We will then preliminarily compare the two conditions in line with the 
intention to treat principle. The purpose of these comparisons is not to provide formal inference 
but provide preliminary information to guide the adequately powered future trial.  
 
The estimated changes and their group differences in pain and depression measured by the BPI-
SF and BDI-II will provide preliminary data on target engagement and therefore inform and 
shape the future trial in terms of elucidating the mechanism of action. We will make a rigorous 
effort to minimize missing data. Nonetheless, we expect some attrition by post-intervention 
assessment. For group comparisons, we will focus on collecting preliminary data on clinical 
significance (i.e. effect size), instead of making formal inference (i.e., p-value). 
 
Inclusion/Exclusion Criteria  
 
Identify inclusion criteria.  
- 
Veteran of the United States Armed Forces ≥ 18 years old  
- 
Diagnosis of chronic musculoskeletal pain > 6 months (Dworkin, 2012)  
- 
Minimum pain intensity at screening visit: pain rated ≥4 on a 0-10 Numeric Rating Scale 
(NRS) as recommended by IMMPACT guidelines. We intend to use the NRS from the 
Defense and Veterans Pain Rating Scale (DVPRS). 
- 
Has not begun new pain treatments or medications in the past month. 
- 
If on a psychotropic medication regimen: stable regimen for at least 4 weeks prior to 
entry to the study; willingness to remain on a stable regimen during the 12-week acute 
treatment phase. 
- 
English literacy. 
- 
Wireless internet connection at home. 
Identify exclusion criteria.  
- 
Participation in another concurrent clinical trial. 
- 
Back surgery within the last 12 months. 
- 
Back pain potentially attributed to a specific underlying cause, disease, or condition. 
- 
Baseline pain <4 or ≥9 on a 0-10 Numeric Rating Scale (NRS) as recommended by 
IMMPACT guidelines. We intend to use the NRS from the Defense and Veterans Pain 
Rating Scale (DVPRS). For ratings ≥9, we will refer the veteran to the provider for 
prompt care. 
- 
Unstable, serious coexisting medical illness. 
- 
Unstable, serious coexisting mental illness or psychiatric conditions. 
- 
 practiced yoga ≥ 1 x in the past 12 months  
- 
Active current suicidal intent or plan. 

 
Criteria will be applied based on the informed consent process, a review of the participant's 
VA electronic medical record (EMR) and a screening interview.  
 
The study will exclude participants with back pain potentially attributed to specific 
underlying causes, diseases, or conditions (e.g. pregnancy, previous back surgery, fractures, 
dislocations); unstable, serious coexisting medical illnesses (e.g. Congestive Heart Failure, 
cancer, COPD, dementia); unstable, serious coexisting mental illnesses or psychiatric conditions 
(e.g. unmanaged psychosis, active substance abuse); or minimal or maximal pain ratings at the 
time of screening (<4 or ≥9 on a 0-10 Numeric Rating Scale (NRS) as recommended by 
IMMPACT guidelines). We intend to use the NRS from the Defense and Veterans Pain Rating 
Scale (DVPRS). 
 
Participants on a psychotropic medication regimen will be asked to maintain a stable 
regimen for at least four weeks prior to entry to the study and remain on a stable regimen during 
the 12-week acute treatment phase, under the patient's medical care team. Excluded participants 
will be reconsidered for eligibility after stability on medication is achieved. Involvement in 
medical treatments will be tracked closely through self-report and clinician interviews, and we 
will use this information when analyzing the results. Participants with active current suicidal 
intent or plan will be excluded. Participants at risk for suicide will be required to establish a 
written safety plan involving their primary psychiatrist and the treatment team, prior to entering 
the clinical trial. 
 
All participants will be able to read, verbalize understanding, and voluntarily sign the 
Informed Consent and Health Insurance Portability & Accountability Act (HIPAA) prior to the 
performance of any study-specific procedures or assessments. 
 
Since we seek to assess the feasibility of providing at-home teleyoga via VA Video 
Connect, all participants will need access to 
wireless internet connection at home. 
 
Informed Consent Process 
Veterans will be recruited from three sources: the VAPAHCS Pain Clinic, local 
advertising, and web-based advertising. These sources will result in either 1) the potential 
participant calling the study team or 2) with the participant’s consent, the study staff contacting 
them directly. Study candidates will be invited to the VAPAHCS for a screening visit, during 
which the Project Manager will obtain informed consent and review the Health Insurance 
Portability & Accountability Act (HIPAA) document.  
 
The informed consent process, including the HIPAA document, is estimated to take about 
30-60 minutes. It will take place in a quiet office or interview room, or via video link. 
1. The Project Manager will explain the information contained in the written informed 
consent (purpose, procedures, risks, benefits, alternatives to participation, etc.) and 
HIPAA documents to the study candidate verbally, in lay language. 

a. The Project Manager will check for comprehension, allow the study candidate 
ample opportunity to ask questions throughout the process, and repeat the 
information, as necessary. 
b. Care will be taken to inform the study candidate that his/her participation is 
entirely voluntary, and they may withdraw at any time and for any reason without 
penalty or loss of benefits to which they would otherwise be entitled. 
c. Study candidates will then be asked to carefully read the informed consent form 
to consider whether or not to participate in the research and to ask questions. 
d. To ensure that the study candidate understands the research, they will next be 
asked to summarize the consent form and HIPAA addendum, with a special focus 
on the discomforts, risks, benefits, and confidentiality sections. 
2. If the study candidate demonstrates (by stating in his/her own words) an understanding of 
the purpose, risks, and benefits of the study and agrees to participate in the study, he/she 
will be asked to initial each page, in addition to sign and date the last page of the consent 
form and the HIPAA document. 
3. The Project Manager who oriented and obtained informed consent will sign and date the 
informed consent form. 
4. The Project Manager will provide the enrolled participant with a photocopy of the 
original signed copy and keep the original signed copy in a binder in a locked cabinet. 
 
The emphasis on the voluntary nature of participation is designed to minimize the possibility 
of coercion or undue influence on participation. The study candidate will be given time to 
understand the written informed consent form and make an informed decision. All treatments for 
this study will be provided in group formats, so potential participants will be reminded that full 
anonymity cannot be maintained. 
 
Following the informed consent process, the enrolled participant will complete other 
measures.  
 
Screening Procedures  
Potential participants (n=30) will be invited to the VAPAHCS for a screening visit. The 
Project Manager will obtain informed consent and review the Health Insurance Portability & 
Accountability Act (HIPAA) document. After obtaining informed consent, a trained researcher 
will collect demographic information (Demographic Questionnaire). Screening for protocol 
eligibility will include the Clinical Questionnaire and DVPRS. 
 
Study Assessments 
Demographics Questionnaire: Documents age, gender, education, and race/ethnicity. 
Clinical Questionnaire: Self-report document focusing on the existence of 78 health symptoms 
taken from a list of ICD-9 codes that are highly likely to represent chronic pain. 
Medication Use: Self-report of all current pharmacological and non-pharmacological treatments. 
Yoga Home Practice Log: Log for participant to document their yoga home practice on non-
treatment days. 
BDI-II Beck Depression Inventory-II (BDI-II): Contains 21 self-report questions, scored on a 
0-3 scale, related over the past two weeks to sleep, appetite, punishment, suicide, and interest in 
sex. 

Brief Pain Inventory-Short Form (BPI-SF): Assesses intensity and impact of pain on 
functioning on a 0-10 rating scale. Interference is assessed on daily life (general, walking, work, 
mood, enjoyment, relationships, sleep). The BPI is recommended by the Initiative on Methods, 
Measurement, and Pain Assessment in Clinical Trials (IMMPACT) group for inclusion in 
clinical trials evaluating pain. 
Defense and Veterans Pain Rating Scale (DVPRS): A five-item scale: one 0-10 pain intensity 
numeric rating scale and four supplemental items measuring functional outcomes (general 
activity, sleep, mood, level of stress). The pain intensity scale is designed to improve upon 
existing scales by using visual cues and word descriptors to anchor pain ratings with perceptual 
experiences and limitations imposed by pain. 
PEG: A 3-item pain measure derived from the Brief Pain Inventory and validated in ambulatory 
care settings. It includes 1 severity item (average pain) and 2 interference items (enjoyment of 
life and general activity). 
Patient-Reported Outcomes Measurement Information System-Pain Interference 
(PROMIS-PI) (108): Examines the extent to which pain hinders engagement over the past seven 
days with social, cognitive, emotional, physical, recreational activities, and physical functioning 
through Likert-type 1-5 scales. 
Treatment Satisfaction: Assessed using the Multi-Dimensional Treatment Satisfaction Measure 
(MDTSM). The measure consists of 11 subscales assessing treatment process and outcome 
attributes. Each subscale has 1-8 items (see Table 5). Each question except the Discomfort 
subscale is rated on a five-point scale ranging from “not at all (0)” to “very much (4)”. Thus, a 
score of 2 represents a rating of neutral satisfaction. The instrument was developed for 
behavioral interventions and is designed to provide a comprehensive set of treatment attributes to 
consider when evaluating treatments in the context of pilot studies. It is designed to be completed 
after exposure to an intervention, to point to aspects of treatments that are viewed favorably or 
unfavorably. The MDTSM is relevant to many types of behavioral interventions and 
can be tailored to our yoga intervention. The MDTSM subscales demonstrates good internal 
consistency, reliability, and validity.  
 
Data Collection  
 
Screening 
Baseline 
Yoga (wks 1-
12) 
Post-treatment 
Background 
 
 
 
 
Consent Form 
˟ 
 
 
 
Demographic Questionnaire  
˟ 
 
 
 
Clinical Questionnaire  
˟ 
 
 
 
Yoga Medical Clearance Form 
˟ 
 
 
 
Medical Use  
 
˟ 
 
˟ 
Yoga Home Practice Log 
 
 
˟ 
 
Mental Health  
 
 
 
 
BDI-II 
 
˟ 
 
˟ 
Pain/QOL/Physical 
 
 
 
 
BPI-SF 
 
˟ 
 
˟ 
DVPRS 
˟ 
 
 
 
PEG 
˟ 
˟ 
 
˟ 
PROMIS-PI 
 
˟ 
 
˟ 
Behavioral  
 
 
 
 

 
Table 2. Study Measures and Timetable of Data Collection  
 
Yoga Treatment 
 
Participants will be randomized to in-person yoga (n=15) or online yoga (n=15). Yoga 
classes will be 75-minutes and will be delivered by a yoga instructor once a week over a course 
of 12 weeks in-person or online.  
 
Yoga (in-person): Veterans in the in-person yoga group will attend yoga classes at VAPAHCS. 
The yoga instructor will provide weekly instruction at the VAPAHCS in a telehealth-equipped 
conference room. 
 
Yoga (online): The yoga instructor will provide weekly instruction using approved 
teleconferencing software either from an offsite location or from the VAPAHCS in a telehealth-
equipped conference room. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment Satisfaction 
 
 
 
˟ 
Provider Suggestions 
 
 
 
˟ 
Patient Safety  
 
 
˟ 
˟ 
Treatment Fidelity  
 
 
˟ 
 

 
 
 IRB Approval Date: November 3, 2021 
Expiration: Does not Expire 
 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
 
What is this research about? 
You are invited to participate in a research study to test whether it is feasible to use 
telehealth to deliver yoga as a treatment for chronic pain. Our goal is to modify an existing 
yoga protocol for musculoskeletal pain and to address the technical challenges of at-home 
teleyoga. You were selected as a possible participant in this study because you have 
indicated that you have been suffering from chronic pain. This research study is looking for 
30 Veterans who exhibit symptoms of chronic pain and want to use yoga via telehealth to 
treat their pain. 
This study is being done by researchers at VA Palo Alto Health Care System and Stanford 
University, and is sponsored by the National Center for Complementary and Integrative 
Health. 
What is expected of me? (Procedures)  
Baseline and Randomization (2-3 hours): You will be asked to complete self-report 
questionnaires about your medication use and experience of chronic pain online through 
Qualtrics or RedCap. If you are randomized to the at-home program, during this session we 
will record your phone number, physical location for at-home teleyoga and an emergency 
contact. This information will be used if the video conferencing session disconnects or an 
unforeseen emergency arises during at-home teleyoga. 
Treatment (12 weeks):  
At-Home Teleyoga: In the first week, you will be given a yoga mat, yoga strap, and 
yoga blocks for use during yoga class. You will then be assigned an iPad and given 
instructions on how to use the video conferencing app to participate in the yoga 
classes at home. You will determine the part of your home that is most comfortable 
and appropriate for a yoga class. You will participate in 1 yoga class per week for 12 
consecutive weeks, 75 minutes per class, at a time that is convenient for the entire 
group and the instructor. A member of the study staff will call you the business day 
before class to remind you of the class appointment and remind you to charge the 
iPad for class. The yoga instructor will be based at the VA Palo Alto, and you will 
participate at home using the video conferencing app on the provided iPad. 
In-Person Yoga: In the first week, you will be given a yoga mat, yoga strap, and yoga 
blocks for use during yoga class. You will be assigned an iPad but will not need it to 
participate in yoga classes. You will participate in 1 yoga class per week at VA Palo 

 
 
 IRB Approval Date: November 3, 2021 
Expiration: Does not Expire 
 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
Alto for 12 consecutive weeks, 75 minutes per class, at a time that is convenient for 
the entire group and the instructor. 
Randomization: You will be randomized to either the in-person or at-home telehealth 
yoga group. Randomization is a process that is similar to flipping a coin where one 
side of the coin is in-person yoga and the other side is at-home teleyoga. There is a 
50:50 chance of being randomized into either treatment. Both groups will receive all 
the same measurements and tests. 
Post-Treatment (2-3 hours): You will be asked to complete self-report questionnaires 
about your medication use and experience of chronic pain, as well as provide feedback 
about the program, including any technical issues you encountered. This will be done either 
in-person at the VA Palo Alto, or online using RedCap or Qualtrics. You will return the iPad 
to study staff in-person at the VA or mail the iPad back to study staff via USPS. 
Video Recording: The in-person and at-home yoga classes will be video recorded to 
monitor instructor fidelity to the yoga intervention manual. Video recording will be used to 
monitor fidelity of treatment delivery. Recordings will be made of treatment providers, not 
the participants. Recordings will be stored on a secure server in accordance with VA 
guidelines. VA record retention polices require records, including videos, created during a 
research project to be maintained for 6 years after study closure, wherein they will be 
destroyed.  
What are the possible risks or discomforts? 
 
The risks associated with this study are minimal. The yoga protocol is developed for participants with 
chronic pain, and you will be encouraged to move safely and modify postures as necessary. If there 
is an unforeseen emergency during your at-home teleyoga session or in-person yoga class, we will 
take the necessary steps to ensure medical help arrives to the address you provided at the start of 
the study.  
 
Will I benefit from the study? 
 
The benefits which may reasonably be expected to result from this study are relief from 
chronic pain. 
 
What are my alternatives to being in this study? 
 
You may choose not to participate in this study. If this is your decision, there are other 
choices including the standard treatments provided by a local clinic. Your study investigator 

 
 
 IRB Approval Date: November 3, 2021 
Expiration: Does not Expire 
 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
will discuss any alternatives with you before you agree to participate in this study. Alternative 
treatments include medication and behavioral therapy.  
 
Will I get paid? 
 
You will receive $200 as payment for your participation. Payments may only be made to U.S. 
citizens, legal resident aliens, and those who have a work eligible visa. You may need to provide 
your social security number to receive payment. 
 
Will I have to pay anything?  
 
You will not have to pay anything to be in this study.  
 
Do I have to be in this study? 
 
Your participation in this study is entirely voluntary. Your decision not to participate will not have any 
negative effect on you or your medical care.  
 
Can I change my mind later and stop being in this study? 
 
You can decide to participate now, but you may withdraw your consent later and stop being in the 
study without any loss of benefits or medical care you are entitled to. 
 
The Protocol Director may also withdraw you from the study without your consent for one or 
more of the following reasons: 
o Failure to follow the instructions of the Protocol Director and study staff. 
o The Protocol Director decides that continuing your participation could be 
harmful to you. 
o Pregnancy  
o You need treatment not allowed in the study. 
o The study is cancelled.  
o Other administrative reasons. 
o Unanticipated circumstances. 
 
Will my information be protected from the public? 
 
We will keep your name and all the information you tell us in this study confidential as possible. We 
may publish the results of this study for others to read about, but you will not be identified in any 
articles about the study by name, social security number, address, telephone number, or any other 
direct personal identifier. Also, other federal agencies as required, such as the VA Office of 

 
 
 IRB Approval Date: November 3, 2021 
Expiration: Does not Expire 
 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
Research Oversight and the VA Office of the Inspector General may have access to your 
information.  
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The 
researchers with this Certificate may not disclose or use information, documents, or biospecimens 
that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other 
action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless 
you have consented for this use. Information, documents, or biospecimens protected by this 
Certificate cannot be disclosed to anyone else who is not connected with the research except, if 
there is a federal, state, or local law that requires disclosure (such as to report child abuse or 
communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or 
other proceedings, see below); if you have consented to the disclosure, including for your medical 
treatment; or if it is used for other scientific research, as allowed by federal regulations protecting 
research subjects. The Certificate of Confidentiality will not be used to prevent disclosure as required 
by federal, state, or local law of harm to self or others. The Certificate of Confidentiality will not be 
used to prevent disclosure for any purpose you have consented to in this informed consent 
document, including research information in the medical record. 
 
What happens if I think I’ve been hurt by being in this study? Who can I talk to about a 
Research Related Injury? 
 
If you are injured as a direct result of being in this study, medical treatment will be available. 
If you are eligible for veteran’s benefits, the cost of such treatment will be covered by the VA. 
If not, the cost of such treatments may still be covered by the VA depending on a number of 
factors. In most circumstances, the treatment must be provided in a VA medical facility. No 
other form of compensation for injuries is available. However, by signing this form you have 
not released the VA from liability for negligence. For further information, you may call the 
Human Protections Administrator at (650) 493-5000, ext. 67593 or the V.A. Regional 
Counsel at (415) 750-2288. 
 
 
Who can I talk to if I have questions about the research, problems related to the study or if I 
think I’ve been hurt by being a part of the study? 
 
If you have any questions, concerns or complaints about this research study, its procedures, risks 
and benefits, or alternative courses of treatment, you should ask the principal investigator, Dr. Peter 
Bayley (650) 493-5000 ext. 68653. You should also contact him at any time if you feel you have 
been hurt by being a part of this study.  
 

 
 
 IRB Approval Date: November 3, 2021 
Expiration: Does not Expire 
 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
If you are not satisfied with how this study is being conducted, or if you have any concerns, 
complaints, or general questions about the research or your rights as a participant, and would like to 
speak someone independent of the research team please contact the Stanford Institutional Review 
Board (IRB) at (650)-723-5244 or toll free at 1-866-680-2906. You can also write to the Stanford 
IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306. 
 
Please print or save a copy of this page for your records. 
 
If you agree to participate in this research, please indicate this to the researchers and complete the 
following survey.