Standardized Yoga & Meditation Program for Stress Reduction for Adolescents With Irritable Bowel Syndrome

NCT05719246 | Recruiting

• 1 other identifier: 19-126
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

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.

Behavioral: Yoga

Interventions

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.

IBS Patients Doing Yoga

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients of Cooper Pediatric Gastroenterology practice in Camden, NJ or Voorhees, NJ
• Patients of Cooper Pediatric Gastroenterology practice in Voorhees, NJ
• Participants 12 to 21 years old with any type of IBS diagnosis
• Subjects must be able to access the internet to be able to watch the yoga videos on Youtube
• Patients must complete 4 out of 6 modules to stay in the study

You may not qualify if:

• Participants under the age of 12
• Participants over the age of 21

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 26690980 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.

  PMID: 29072609 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.

  PMID: 11113099 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.

  PMID: 21647811 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.

  PMID: 31135603 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.

  PMID: 30113959 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.

  PMID: 29881232 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.

  PMID: 25187105 BACKGROUND

• 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.

  PMID: 12454866 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome; Anxiety Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Alla Kushnir, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alla Kushnir, MD

CONTACT

856-342-2265; kushnir-alla@cooperhealth.edu

Sydney Topfer, BS

CONTACT

201-563-5715; topfer36@rowan.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: February 8, 2023
• Study Start: December 30, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)