Recruiting

Yoga & Meditation

Sponsor:

The Cooper Health System

Code:

NCT05719246

Conditions

Irritable Bowel Syndrome

Anxiety

Quality of Life

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Accepted

Interventions

Yoga

Study Details

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

Study ID

NCT05719246

Start date

Dec 30, 2020

Status verified date

Oct, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Pediatric Quality of Life [ Time Frame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks) ]
  • Children Somatic Symptoms Inventory [ Time Frame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks) ]
  • Anxiety [ Time Frame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks) ]

Central Contacts and Locations

Central contacts

Alla Kushnir, MD

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

Sydney Topfer, BS

201-563-5715topfer36@rowan.edu

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Alla Kushnir, MD

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

Principal Investigator:

Alla Kushnir, MD

More Information

Sponsor

The Cooper Health System

Last update posted

Oct 15, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2024-10-15.