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

Primary Purpose

Irritable Bowel Syndrome, Anxiety, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Participants under the age of 12 Participants over the age of 21

Sites / Locations

  • Cooper University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IBS Patients Doing Yoga

Arm Description

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.

Outcomes

Primary Outcome Measures

Pediatric Quality of Life
Pediatric Quality of Life Inventory questionnaire will be used
Children Somatic Symptoms Inventory
Children Somatic Symptoms Inventory questionnaire will be used
Anxiety
Screen for Child Anxiety Related Disorders questionnaire will be used

Secondary Outcome Measures

Full Information

First Posted
March 7, 2022
Last Updated
February 7, 2023
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05719246
Brief Title
Standardized Yoga & Meditation Program for Stress Reduction for Adolescents With Irritable Bowel Syndrome
Official Title
Standardized Yoga & Meditation Program for Stress Reduction for Adolescents With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Anxiety, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBS Patients Doing Yoga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Quality of Life
Description
Pediatric Quality of Life Inventory questionnaire will be used
Time Frame
Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Title
Children Somatic Symptoms Inventory
Description
Children Somatic Symptoms Inventory questionnaire will be used
Time Frame
Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Title
Anxiety
Description
Screen for Child Anxiety Related Disorders questionnaire will be used
Time Frame
Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Participants under the age of 12 Participants over the age of 21
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alla Kushnir, MD
Phone
856-342-2265
Email
kushnir-alla@cooperhealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney Topfer, BS
Phone
201-563-5715
Email
topfer36@rowan.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alla Kushnir, MD
Organizational Affiliation
The Cooper Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alla Kushnir, MD
Phone
856-342-2265
Email
kushnir-alla@cooperhealth.edu
First Name & Middle Initial & Last Name & Degree
Sydney Topfer, BS
First Name & Middle Initial & Last Name & Degree
Marisa Wozniak, BS
First Name & Middle Initial & Last Name & Degree
Natalie Morris, BS
First Name & Middle Initial & Last Name & Degree
Katherine Kaminski, BS
First Name & Middle Initial & Last Name & Degree
Alla Kushnir, MD
First Name & Middle Initial & Last Name & Degree
Basant Pradhan, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26690980
Citation
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.
Results Reference
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PubMed Identifier
29072609
Citation
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.
Results Reference
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PubMed Identifier
11113099
Citation
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.
Results Reference
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PubMed Identifier
21647811
Citation
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.
Results Reference
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PubMed Identifier
31135603
Citation
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.
Results Reference
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PubMed Identifier
30113959
Citation
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.
Results Reference
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PubMed Identifier
29881232
Citation
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.
Results Reference
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PubMed Identifier
25187105
Citation
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.
Results Reference
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PubMed Identifier
12454866
Citation
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Results Reference
result

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

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