A Trial of Yoga in Pediatric Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT03338894|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis||Behavioral: Yoga||Not Applicable|
Approximately 25% of Inflammatory bowel disease (IBD) is diagnosed in the pediatric age group, with the peak age of onset in the adolescent years. IBD adds additional stressors of a chronic disease with unpredictable and potentially embarrassing symptoms to the expected challenges of psychological and social adjustment that teenagers face. Various techniques, such as psychotherapy programs and IBD overnight camp experiences, have been studied to decrease psychological distress and improve quality of life. Stress, and particularly how stressful events are perceived, may play a role in triggering IBD flares. Complementary and alternative medicine (CAM), especially mind-body techniques are used often by pediatric IBD patients and may be beneficial in decreasing stress and improving quality of life (QOL). Yoga may be well suited as an adjunct to conventional IBD therapy to decrease stress, provide a greater sense of bodily control and improve QOL.
The primary goal of this project is to determine if a structured Yoga program, in addition to standard medical therapy, improves HRQOL in pediatric patients diagnosed with inflammatory bowel disease (IBD). Investigators will also examine if the yoga program improves self efficacy, which is a person's belief about their ability to influence events that affect their lives. Disease response and remission rates will be followed as well, in order to stratify HRQOL outcomes in the yoga group.
Patients will each serve as their own control and complete questionnaires at enrollment and at the start and end of the 12 week group yoga class sessions. They will also complete the questionnaires three months after finishing the class sessions. .The program will consist of a live group class session over 12 weeks. Baseline and follow-up questionnaires will be used to determine there are changes in QOL, self-efficacy, and disease response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Controlled Trial of Yoga in Pediatric Inflammatory Bowel Disease (IBD)|
|Actual Study Start Date :||December 20, 2017|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Each subject will serve as their own control
1 Hour yoga class
- Pediatric Quality of Life [ Time Frame: 90 Days ]The number of patients diagnosed with Inflammatory Bowel disease that have shown an improved health related quality of life (HRQOL) as assessed by the Pediatric Quality of Life survey after a structured yoga program, comparing pre-yoga HRQOL to post-yoga HRQOL. The Peds QOL age related surveys are validated pediatric questionnaires that measure general HRQOL in children ages 8-17 years. They consist of 23 questions in areas of social, school, emotional and physical functioning. The answers are scored on a 5 point scale and then reverse scored and linearly transformed to a scale of 1-100 scale.
- General Self Efficacy Scale [ Time Frame: 90 days ]This is a 10 item scale that measures a patient's general sense of perceived self-efficacy, aiming to predict coping with daily life as well as adaptation after stressful life events. The General Self Efficacy Scale is correlated to emotion, optimism, and work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout and anxiety. The total score is calculated by finding the sum of all item. For the General Self-Efficacy, the total score ranges between 10 to 40, with a higher score indicating more self-efficacy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338894
|Contact: Alycia Leiby, MDfirstname.lastname@example.org|
|Contact: Annette Langseder, RN, BSNemail@example.com|
|United States, New Jersey|
|Morristown Memorial Hospital/Goyerb Children's Hospital||Recruiting|
|Morristown, New Jersey, United States, 07962|
|Contact: Research Coordinator 973-971-5676|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia/Roberts Center for Pediatric Research||Recruiting|
|Philadelphia, Pennsylvania, United States, 19146|
|Contact: Naomi Pressman, MS, RD 267-426-8413|
|Principal Investigator:||Alycia Leiby, MD||Atlantic Health/Goryeb Children's Hospital|