An interventional study of Yoga in Irritable Bowel Syndrome, Anxiety and Quality of Life, sponsored by The Cooper Health System. Recruiting at 1 site in United States. Open to participants aged 12 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by The Cooper Health System · Not applicable, Interventional, and Supportive care
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's planned enrollment of 10 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →The Cooper Health System is the lead sponsor of 67 studies on the registry; 18 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Pediatric Quality of Life
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)
Children Somatic Symptoms Inventory
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)
Anxiety
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)
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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