The purpose of this study is to: 1. Determine if audio recorded guided imagery vs deep breathing exercises delivered via a digital media player improves abdominal pain symptoms in children with functional gastrointestinal pain disorders managed in the primary care setting. 2. Determine if audio recorded guided imagery and deep breathing exercises delivered via a digital media player improves psychosocial distress in children affected by functional gastrointestinal pain disorders managed in the primary care setting. The possibility of treating functional gastrointestinal pain disorders using remotely delivered psychosocial therapies has the potential to treat many children affected by functional gastrointestinal pain disorders in a cost-effective manner. This study will provide insight into how well these patients in the primary care could benefit from such interventions.
Children managed in primary care with a functional gastrointestinal pain disorder will be recruited and studied for this trial. After participants are deemed eligible, they will complete multiple questionnaires and then be randomly assigned (like a flip of a coin) to either guided imagery or deep breathing exercises delivered via a digital media player. Participants will be instructed to listen to the tracks at least 5 days per week for an 8 week intervention period. At week 3 of the intervention period, the participant will complete another 2 week pain and stool diary. At week 7 of the intervention period, the participant will complete another 2 week pain and stool dairy. After this diary is completed, the participant will again complete multiple questionnaires for their final visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
One session at least 5 days a week for a total of 8 weeks
Texas Children's Hospital
Houston, Texas, United States
Change in abdominal pain symptoms
Abdominal Pain Index
Time frame: Change from Baseline to 8 weeks post-treatment
Improvement in health-related quality of life
Pediatric Quality of Life Inventory (Peds QL) Questionnaire
Time frame: Change from Baseline to 8 weeks post-treatment
Change in Psychosocial Distress
Behavior Assessment System for Children (BASC 3) Questionnaire
Time frame: Change from Baseline to 8 weeks post-treatment
Adherence to Intervention
Count of Number of Sessions Played
Time frame: 8 weeks after treatment
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