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Irritable Bowel Syndrome (IBS) 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. This discomfort leads to emotional stress, decreased quality of life, and anxiety. The study proposes 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.
Background: Irritable Bowel Syndrome (IBS), 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. 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. Since IBS is often accompanied by anxiety, along with other psychological and quality of life issues, it will be evaluated whether practicing yoga and mindfulness will decrease anxiety and increase quality of life for patients with IBS
Objective: 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.
Methods: This is a pilot, IRB approved, prospective study. Children ages 12-21 who suffer from any of the four types of Irritable Bowel Syndromes will be identified. Each subject will be asked to fill out the Screen for Child Anxiety Related Disorders, Children Somatic Symptoms Inventory and Pediatric Quality of Life Inventory questionnaires before and after an online, 6- week yoga course. 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 and Children Somatic Symptoms Inventory tests. 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. The difference will be considered significant at p<0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBS Patients Doing Yoga | Experimental | All patients will fall under the arm of "IBS Patients Doing Yoga" and will follow the yoga videos that are assigned to them during the study. The participants are their own controls and their symptom changes will be recorded pre- and post-video watching and participation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Behavioral | The yoga video set that the participants will follow is a brief, at-home, 6-week twice per week Standardized Yoga & Meditation Program for Stress Reduction (SYMPro-SR) program. The videos feature Sydney Topfer guiding the participants through different yoga poses. |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Quality of Life | Pediatric Quality of Life Inventory questionnaire will be used | Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks) |
| Children Somatic Symptoms Inventory | Children Somatic Symptoms Inventory questionnaire will be used | Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks) |
| Anxiety | Screen for Child Anxiety Related Disorders questionnaire will be used | Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alla Kushnir, MD | Contact | 856-342-2265 | kushnir-alla@cooperhealth.edu | |
| Sydney Topfer, BS | Contact | 201-563-5715 | topfer36@rowan.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alla Kushnir, MD | The Cooper Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Recruiting | Camden | New Jersey | 08103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26690980 | Background | Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Epub 2015 Dec 21. | |
| 29072609 | Background | Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. J Clin Med. 2017 Oct 26;6(11):99. doi: 10.3390/jcm6110099. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2021 | Mar 17, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 29, 2021 | Mar 17, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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|
| 11113099 | Background | Locke GR 3rd, Pemberton JH, Phillips SF. AGA technical review on constipation. American Gastroenterological Association. Gastroenterology. 2000 Dec;119(6):1766-78. doi: 10.1053/gast.2000.20392. |
| 21647811 | Background | Khalsa SB, Hickey-Schultz L, Cohen D, Steiner N, Cope S. Evaluation of the mental health benefits of yoga in a secondary school: a preliminary randomized controlled trial. J Behav Health Serv Res. 2012 Jan;39(1):80-90. doi: 10.1007/s11414-011-9249-8. |
| 31135603 | Background | Huguet A, Izaguirre Eguren J, Miguel-Ruiz D, Vall Valles X, Alda JA. Deficient Emotional Self-Regulation in Children with Attention Deficit Hyperactivity Disorder: Mindfulness as a Useful Treatment Modality. J Dev Behav Pediatr. 2019 Jul/Aug;40(6):425-431. doi: 10.1097/DBP.0000000000000682. |
| 30113959 | Background | Evans S, Seidman LC, Lung K, Sternlieb B, Zeltzer LK. Yoga for Teens With Irritable Bowel Syndrome: Results From a Mixed-Methods Pilot Study. Holist Nurs Pract. 2018 Sep/Oct;32(5):253-260. doi: 10.1097/HNP.0000000000000288. |
| 29881232 | Background | Devanarayana NM, Rajindrajith S. Irritable bowel syndrome in children: Current knowledge, challenges and opportunities. World J Gastroenterol. 2018 Jun 7;24(21):2211-2235. doi: 10.3748/wjg.v24.i21.2211. |
| 25187105 | Background | Reigada LC, Hoogendoorn CJ, Walsh LC, Lai J, Szigethy E, Cohen BH, Bao R, Isola K, Benkov KJ. Anxiety symptoms and disease severity in children and adolescents with Crohn disease. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):30-5. doi: 10.1097/MPG.0000000000000552. |
| 12454866 | Result | Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002 Dec;123(6):2108-31. doi: 10.1053/gast.2002.37095. No abstract available. |
| D004066 | Digestive System Diseases |
| D001523 | Mental Disorders |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |