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NCT Number: NCT05719246

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

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.

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Key information

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location status: Recruiting

Location contact

Alla Kushnir, MD

CONTACT

[email protected]

856-342-2265

Alla Kushnir, MD

PRINCIPAL_INVESTIGATOR

Basant Pradhan, MD

SUB_INVESTIGATOR

Katherine Kaminski, BS

SUB_INVESTIGATOR

Marisa Wozniak, BS

SUB_INVESTIGATOR

Natalie Morris, BS

SUB_INVESTIGATOR

Sydney Topfer, BS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pediatric Quality of Life

    Time frame: 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

    Time frame: 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alla Kushnir, MD

CONTACT

[email protected]

856-342-2265

Sydney Topfer, BS

CONTACT

[email protected]

201-563-5715

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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