Clinical trial NCT05719246: 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
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Anxiety
Quality of Life
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pediatric Quality of Life
timeFrame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
measure: Children Somatic Symptoms Inventory
timeFrame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
measure: Anxiety
timeFrame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Alla Kushnir, MD
role: PRINCIPAL_INVESTIGATOR
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