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

Sponsor
The Cooper Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05719246
Collaborator
(none)
10
1
1
59.5
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Standardized Yoga & Meditation Program for Stress Reduction for Adolescents With Irritable Bowel Syndrome
Actual Study Start Date :
Dec 30, 2020
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: IBS Patients Doing Yoga

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
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.

Outcome Measures

Primary Outcome Measures

  1. Pediatric Quality of Life [Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)]

    Pediatric Quality of Life Inventory questionnaire will be used

  2. Children Somatic Symptoms Inventory [Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)]

    Children Somatic Symptoms Inventory questionnaire will be used

  3. Anxiety [Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)]

    Screen for Child Anxiety Related Disorders questionnaire will be used

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cooper University Hospital Camden New Jersey United States 08103

Sponsors and Collaborators

  • The Cooper Health System

Investigators

  • Principal Investigator: Alla Kushnir, MD, The Cooper Health System

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
The Cooper Health System
ClinicalTrials.gov Identifier:
NCT05719246
Other Study ID Numbers:
  • 19-126
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023