Standardized Yoga & Meditation Program for Stress Reduction for Adolescents With Irritable Bowel Syndrome
Phase: NA
Conditions: Irritable Bowel Syndrome, Anxiety, Quality of Life
Sponsor: The Cooper Health System

 
 
 
 
 
 
 
 
 
Sydney Topfer, Alla Kushnir MD, Marisa Wozniak, Basant Pradhan MD, Natalie Morris 
 
Sydney Topfer: 401 Broadway, Camden, NJ 08103. Topfer36@rowan.edu. 201-563-5715.  
 
Alla Kushnir MD, Marisa Wozniak, Basant Pradhan MD, Natalie Morris: 1 Cooper Plaza, 
Camden, NJ 08103. Cooper University Hospital. Camden, NJ 
 
Pediatric  
Irritable Bowel Syndrome 
Yoga 
Anxiety 
Gastroenterology  
 
3301 Words 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Abstract 
 
 
Introduction: Irritable Bowel Syndrome is the most common cause of recurrent abdominal pain 
in children. IBS is a functional gastrointestinal disorder that is linked to motor and sensory 
physiology, as well as the central nervous system, that presents as abdominal pain with abnormal 
defecation patterns {Drossman et al., 2002}. This discomfort leads to emotional stress, decreased 
quality of life, and anxiety. We are proposing that yoga and mindfulness will decrease anxiety 
and increase quality of life for patients with IBS. The aim of this study is to measure the impact 
of a brief, at-home, 6-week twice per week Standardized Yoga & Meditation Program for Stress 
Reduction program on anxiety, IBS symptoms, and quality of life in children ages 12-21 
diagnosed with IBS. 
 
Methods and Analysis: This is a pilot, IRB approved, prospective study. Each subject will fill 
out the Screen for Child Anxiety Related Disorders to measure anxiety, and Children Somatic 
Symptoms Inventory and Pediatric Quality of Life Inventory questionnaires to measure quality 
of life, before and after an online yoga course. Results of the questionnaires total scores and sub-
scales will be analyzed as continuous variables using paired t-tests or the Wilcoxon signed rank 
tests for the pre-post results and ANCOVA for repeated measures incorporating age, sex, 
baseline scores, etc. as covariates. Comparisons within the group will be done using Student 
paired t-test for continuous data. A minimum sample size of 45 subjects will be required. This 
estimate is based on a standard deviation of the SCARED total score of 10, a two-tailed p-value 
of 0.05 and 80% power. 
 
Ethics and Dissemination: All subject information will be kept strictly confidential, except as 
may be required by law. Data will be published and disseminated through future publications. 
IRB 19-126 
 
Strengths and Limitations of the Study  
Strengths: 
- 
Alternative medical treatment  
- 
Accessible to many families  
- 
Does not alter original treatment plan  
- 
Very low risk  
Limitations: 
- 
Takes 6 weeks to complete  
 
 
 
 
 
 
 
 
 
 

Standardized Yoga & Meditation Program for Stress Reduction for Adolescents with Irritable 
Bowel Syndrome  
 
Sydney Topfer, Alla Kushnir MD, Marisa Wozniak, Basant Pradhan MD 
 
A. Objective/Purpose 
  
The aim of this study is to measure the impact of a brief, at-home, 6-week twice per week 
Standardized Yoga & Meditation Program for Stress Reduction (SYMPro-SR) program on 
anxiety, IBS symptoms, and quality of life in children ages 12-21 years old diagnosed with 
Irritable Bowel Syndrome. 
  
B. Hypothesis 
  
A brief, at-home, yoga and mindfulness program will decrease anxiety and irritable bowel 
symptoms while increasing quality of life in children ages 12 to 21 years old diagnosed with 
Irritable Bowel Syndrome. 
  
C. Background 
  
IBS, or Irritable Bowel Syndrome, is the most common cause of general recurrent 
abdominal pain (RAP) in children. IBS is a functional gastrointestinal disorder that is linked to 
motor and sensory physiology, as well as the central nervous system, that presents as abdominal 
pain with abnormal defecation patterns [1]. This discomfort often significantly impacts the 
patient’s life, leading to emotional stress, decreased quality of life due to necessary changes in 
daily living to accommodate bathroom patterns, as well as anxiety and depression. When 
children present with RAP, the Rome IV is used to clinically diagnose patients with a specific 
type of IBS. These criteria include recurrent abdominal pain at least one day per week in the last 
three months on average, associated with greater than or equal to two of the following: related to 
defecation (either increasing or improving pain), associated with a change in stool frequency, 
and associated with a change in stool form [2]. There are four distinct types of IBS, which are 
IBS with predominant constipation (IBS-C), IBS with predominant diarrhea (IBS-D), with mixed 
bowel habits (IBS-M) or IBS, unsubtyped [3]. IBS-C is accompanied by stomach discomfort, 
bloating, and infrequent or difficult evacuation of feces (a bowel movement every three to four 
days). IBS-D is also accompanied by stomach pain, but the patient has an urgent need to move 
the bowels and the feces is usually loose and watery. IBS-M is accompanied by an alternation 
between the patient not being able to make a bowel movement and the patient making frequent, 
urgent, loose and watery bowel movements [4]. The last type, IBS, unsubtyped, is accompanied 
by hard or loose stools less than 25% of the time [3]. In children, it is especially important to 
make the correct diagnosis of IBS as early as possible in order to implement the most appropriate 
treatment at the earliest time possible. 
Since IBS is often accompanied by anxiety, along with other psychological and quality of 
life issues, we are proposing that practicing yoga and mindfulness will decrease anxiety and 
increase quality of life for patients with IBS. Yoga includes postures, exercises, various 

breathing techniques, relaxation practices, and meditation to improve the mental and physical 
health of the person [5]. Mindfulness as a practice is based on focusing all of the person’s 
attention on the sensations around them and their own breathing in order to fully take in the 
current moment [6]. Both yoga and mindfulness have been used in various settings as a way to 
decrease anxiety and manage stress. For example, Huguet et al found that using mindfulness-
based group therapy significantly lowered levels of anxiety, depression, and aggression of 
children with ADHD [7]. They force the person to be aware of their own bodies and how they 
feel in the present moment, and help to balance all of the internal and external stimulation they 
are receiving. Yoga and meditation are beginning to be used as part of a holistic therapy 
approach to various medical treatment plans. For example, Evans et al found that relative to 
controls, young adults (18–26 years) assigned to yoga as part of their IBS treatment plan reported 
significantly improved IBS symptoms, global improvement, disability, psychological distress, 
sleep quality, and fatigue [8]. The idea behind these studies is to decrease the anxiety and stress 
that accompany difficult diagnoses, painful treatments, and the overall stress that patients 
undergo in their disease state.  
The goal of this study is to use a brief yoga and mindfulness program to decrease anxiety 
and irritable bowel symptoms while increasing quality of life in children ages 12 to 21 who 
suffer from IBS. Yoga and mindfulness help people become more aware of their bodies and 
physical functions, so by making children with IBS more aware of how they feel and correlating 
that with their IBS symptoms, we are hoping that the symptoms themselves become more 
controllable and eventually decrease. IBS has a strong psychological component, which is why 
using techniques such as yoga and mindfulness as therapy options are promising for patients.  
 
Description of the Standardized Yoga & Meditation Program for Stress Reduction 
(SYMPro-SR): SYMPro-SR is the wellness program developed by Pradhan in 1993 during his 
monastic training. Initially he piloted it in a normal and healthy population in India as a means 
for stress reduction, improvement of productivity, and improvement of quality of life. This 
model purports to use Yoga in its entirety (i.e., all eight limbs including meditation, its 7th limb) 
rather than in a piecemeal fashion. SYMpro-SR has been adapted from the three original 
traditions of Yoga and mindfulness, i.e., Buddha’s vipassana meditation (satipat- thana), 
Patanjali’s Eight-Limbed Yoga (ashtanga), and the standardized and technique-rich traditions of 
Tantra (Pradhan, 2014). This model uses neurobiologically informed bottom-up model of 
meditation (Pradhan, 2014, chapter three) and are compatible with other Western models of 
therapy including cognitive behavioral therapy (CBT). The efficacy of this model for wellness 
has been established by Pradhan and colleagues in healthy and clinical population including in a 
population of Resident physicians and medical students in Thomas Jefferson University (2011-
2012) and Cooper University Hospitals (2014-2017). 
 
 
 D. Significance of this Research 
  
Finding ways to improve symptoms of chronic illness in children is pivotal to their quality of 
life. Devanarayana states that Irritable Bowel Syndrome has significant effects on the quality of 
life of patients, so it is important to continuously research ways to improve symptoms [9]. By 
implementing a mind-body approach to care, we are giving patients tools to take with them 

beyond their pediatric years so that they are able to control their symptoms long-term. This study 
will determine if yoga and mindfulness can be integrated into their care. 
 
E. Proposed Research Plan 
 
1. Subjects: 
a. Number of subjects 
Based on the primary outcome, SCARED scores, in order to detect a difference of 
20% in the pre and post yoga SCARED scores (i.e, 30 vs 24), a minimum sample 
size of 45 subjects will be required. This estimate is based on a standard deviation 
of the SCARED total score of 10, a two-tailed p-value of 0.05 and 80% power. 
Subjects will be chosen from January 1st 2021 to January 1st 2022.  
 
b. Inclusion Criteria  
i. Patients of Cooper Pediatric Gastroenterology practice in Camden, NJ or 
Voorhees, NJ 
ii. Subjects must be able to access the internet to be able to watch the yoga 
videos on Youtube  
iii. Must be ages 12-21 
iv. Patients must complete 4/6 modules to stay in the study  
 
c. Exclusion Criteria 
i. Under the age of 12 or over the age of 21 
 
d. Recruitment Methods: Patients at Cooper’s pediatric gastroenterology offices in either 
Camden, NJ or Voorhees, NJ will be screened for our study and approached by 
researchers over the phone for agreement to be in the study. If they agree, they will 
provide their email address, we will send over the consent forms to be read over, and 
an additional meeting will be set up for verbal consent.  
 
e. Informed Consent Process: Parents will be approached by researchers over the phone, 
based off of Cooper Pediatric Gastroenterology IBS patient list, to see if they want 
their child to participate in our study. If so, parents and/or children will be emailed a 
consent form to read over, and we will set up an additional phone call to gather 
consent verbally. This second phone call may be approximately 30 minutes to 120 
minutes. Parents and their children will be requested to verbally consent and/or the 
assent.Parents and/or children will be emailed to read for their information and 
allowed until the end of the phone call to decide whether they want to participate in 
the study. If so, a consent form will be emailed to parents to read over, and we will set 
up an additional phone call to gather consent. This may be approximately 30 minutes 
to 120 minutes. If they agree, they and their children will be requested to verbally 
consent and/or the assent. Subjects ages 18-21 will verbally consent an adult 
consent/HIPPA authorization to participate, children ages 14-17 will verbally consent 
an assent form and we will obtain verbal assent from children ages 12-13 with an age 
appropriate assent script. Parental permission will be obtained from the parent of every 
child participant. Questions can be answered by the researchers.  

 
  
2. Research Methods and Procedures  
a. General Description of Methods and Procedures  
Patients of Cooper’s pediatric gastroenterology offices in either Camden, NJ or 
Voorhees, NJ will be screened for our study. Children ages 12-21 who suffer from 
any of the four types of Irritable Bowel Syndromes will be identified. Parents will be 
called to see if patient wants to be involved in the study. If yes, parents will provide 
an email address where a consent or assent form can be sent. An additional phone call 
will be scheduled to provide verbal consent over the phone, in addition to the 
questionnaires. Patients ages 12-17 will verbally agree to an assent form and their 
parent or guardian will verbally agree to a consent form. Patients ages 18-21 will 
verbally agree to their own consent form. Each subject will be asked over the phone 
to fill out the Screen for Child Anxiety Related Disorders (SCARED) [10] and 
Pediatric Quality of Life Inventory (PedsOL) [8] questionnaires. Researchers will 
perform the study assessments with the children. The primary outcome of the study 
will be the measurement of child anxiety using the 41-item SCARED questionnaire 
(with 5 subscales) before and after the six-week Yoga-meditation intervention. 
Secondary outcomes include the Pediatric Quality of Life Inventory (PedsQL) and 
Children Somatic Symptoms Inventory measured before and after the yoga program. 
Subjects will be emailed a private youtube.com link with access to 6 yoga videos for 
their 6- week course. Each video will be played two times per week. Both survey 
instruments have been validated and used in pediatric studies. A standardized 
meditation home practice log will be used to objectively measure the daily practice 
pattern and duration of meditation.  
 
Subjects will fill out a calendar for the days and times they completed the modules. 
After three weeks, researchers will call subjects with the phone number provided to 
assess adherence. After 6 weeks, researchers will call the subjects again with the 
phone number provided and fill out the Screen for Child Anxiety Related Disorders 
and Pediatric Quality of Life Inventory questionnaires again, this time over the phone.  
 
b. Summary of Visits and Procedures  
Patients of Cooper’s pediatric gastroenterology offices in either Camden, NJ or 
Voorhees, NJ will be screened for our study. Parents will be called to see if they want 
to participate in our study. If so, parents and/or children will be emailed a consent 
form to read over, and we will set up an additional phone call to gather consent 
verbally. This second phone call may be approximately 30 minutes to 120 minutes. 
Parents and their children will be requested to verbally consent and/or the assent.  
 
c. Procedures Just for Research Purposes 
Screen for Child Anxiety Related Disorders, Pediatric Quality of Life Inventory and 
Children's Somatic Symptoms Inventory  
 
d. How Participation Differs from Standard-of-Care 

Patients will fill out the Screen for Child Anxiety Related Disorders, Children Somatic 
Symptoms Inventory and Pediatric Quality of Life Inventory questionnaires and 
participate in a brief, at-home, 6-week twice per week yoga module. All of the above 
screening tools and modules are not the standard of care for IBS patients and would 
not be done if patient were not to be participating in the study. They will continue to 
receive the standard of care medical management for IBS as provided by their 
gastroenterologist  
 
e. Patient and Public Involvement  
The development of the research question and outcome measures informed by patients 
priorities were determined based on the need for alternative treatment methods for 
children who suffered with IBS. Patients were not involved in the design of the study. 
Patients were not involved in the recruitment to and conduct of the study. Results will 
be published publicly after the data collection is complete. This was not a randomized 
control trial. We thank all of our patients for their contribution to our study.  
 
 
3. Data Analysis  
Children who qualify for this study will be given a pre-test and post-test to 
measure anxiety and quality of life, as described above. Anxiety will be measured using 
the Screen for Child Anxiety Related Disorders and quality of life will be measured using 
Pediatric Quality of Life Inventory test. Results of the SCARED and PedsQL total scores 
and sub-scales will be analyzed as continuous variables using paired t-tests or the 
Wilcoxon signed rank tests for the pre-post results and ANCOVA for repeated measures 
incorporating age, sex, baseline scores, etc. as covariates. Comparisons within the group 
will be done using Student paired t-test for continuous data. The difference will be 
considered significant at p0.05.  
 
 
 
F. Risk and benefits 
1. Potential Risks to Subjects 
One potential risk is loss of subject’s privacy and confidentiality. All information about 
patients and the study will be kept strictly confidential, except as may be required by law. 
Another potential risk is minor a minor injury due to yoga. The modules require minimal 
strenuous activity, but there is always a risk and patient will need to reach out to a 
physician with a concerns immediately.  
 
2. Potential benefits 
The subjects may benefit from this study if their anxiety levels decrease and/or their 
quality of life increases. The knowledge gained from this study may benefit future IBS 
patients and help in integrative care of a pediatric chronic illness.  
 
3. Risk: benefit ratio  
The potential risk to the subject is of loss of privacy and confidentiality, which can be 
minimized by keeping information strictly confidential, and minor yoga-related injury, 

which can be minimized by careful description of specific postures. There is a potential 
benefit for current and future patients. The benefit outweighs the risk for the integrative 
care of IBS.  
 
G. Monitoring Subject Safety  
The subjects will be called after 3 weeks to ensure they are doing well with the yoga modules. 
An email address will be provided if the subjects have questions about the study.  
 
H. Procedures Necessary to Maintain Privacy and Confidentiality  
All information obtained in this study will be strictly confidential, except, as may be required by 
law. Each subject will be assigned a number and patient’s name and identifying information with 
that number will be kept in a separate locked cabinet. We will use only the assigned number to 
the subjects on the questionnaires and calendar tracker. All the files and records created for this 
study will be stored in Dr. Kushnir’s office at 755 Dorrance and Cooper Hospital in a locked 
cabinet or in a computer with a password. Any publication resulting from this study will refer to 
the patient by a pre-assigned number. No published data will disclose the identity of any patient. 
 
I. Strengths and Limitations of the Study  
Strengths: 
- 
Alternative medical treatment  
- 
Accessible to many families  
- 
Does not alter original treatment plan  
- 
Very low risk  
Limitations: 
- 
Takes 6 weeks to complete  
 
J. Funding 
 contributorship statements – not applicable  
 competing interests – not applicable 
 funding – not applicable 
 
K. References  
[1] Drossman, D. A., Camilleri, M., Mayer, E. A., & Whitehead, W. E. (2002). AGA technical 
review on irritable bowel syndrome. Gastroenterology, 123(6), 2108-2131. 
 
[2] Chumpitazi, B. P., Self, M. M., Czyzewski, D. I., Cejka, S., Swank, P. R., & Shulman, R. J. 
(2016). Bristol Stool Form Scale reliability and agreement decreases when determining Rome III 
stool form designations. Neurogastroenterol Motil, 28(3), 443-448.  
 
[3] Lacy, B. E., & Patel, N. K. (2017). Rome Criteria and a Diagnostic Approach to Irritable 
Bowel Syndrome. J Clin Med, 6(11). doi:10.3390/jcm6110099 
 
[4] Locke, G. R., Pemberton, J. H., & Phillips, S. F. (2000). AGA technical review on 
constipation. American Gastroenterological Association. Gastroenterology, 119(6), 1766-1778. 
 

[5] Khalsa, S.B.S., Hickey-Schultz, L., Cohen, D. et al. J Behav Health Serv Res (2012) 39: 
80. https://doi.org/10.1007/s11414-011-9249-8 
[6] Bishop, S. R., Lau, M., Shapiro, S., Carlson, L., Anderson, N. D., Carmody, J. et al. (2004). 
Mindfulness: A proposed operational definition. Clinical psychology: Science and practice, 
11(3), 230-241. 
 
[7] Huguet, A., Izaguirre Eguren, J., Miguel-Ruiz, D., Vall Vallés, X., & Alda, J. A. (2019). 
Deficient Emotional Self-Regulation in Children with Attention Deficit Hyperactivity Disorder: 
Mindfulness as a Useful Treatment Modality. J Dev Behav Pediatr. 
doi:10.1097/DBP.0000000000000682 
 
[8] Evans, S., Seidman, L. C., Lung, K., Sternlieb, B., & Zeltzer, L. K. (2018). Yoga for Teens 
With Irritable Bowel Syndrome: Results From a Mixed-Methods Pilot Study. Holist Nurs Pract, 
32(5), 253-260. doi:10.1097/HNP.0000000000000288 
 
[9] Devanarayana NM, Rajindrajith S. Irritable bowel syndrome in children: Current knowledge, 
challenges and opportunities. World J Gastroenterol. 2018;24(21):2211–2235. 
doi:10.3748/wjg.v24.i21.2211 
 
[10] Reigada, L. C., Hoogendoorn, C. J., Walsh, L. C., Lai, J., Szigethy, E., Cohen, B. 
H., . . . Benkov, K. J. (2015). Anxiety symptoms and disease severity in children and adolescents 
with Crohn disease. J Pediatr Gastroenterol Nutr, 60(1), 30-35. 
doi:10.1097/MPG.0000000000000552