Texas Children's Hospital
Houston, Texas, 77030, United States
NCT Number: NCT03100487
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.
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Notify Me8 year–12 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One session at least 5 days a week for a total of 8 weeks
Time frame: Change from Baseline to 8 weeks post-treatment
Abdominal Pain Index
Time frame: Change from Baseline to 8 weeks post-treatment
Pediatric Quality of Life Inventory (Peds QL) Questionnaire
Time frame: Change from Baseline to 8 weeks post-treatment
Behavior Assessment System for Children (BASC 3) Questionnaire
Time frame: 8 weeks after treatment
Count of Number of Sessions Played
Baylor College of Medicine
Other
Efficacy of Remote Audio Recorded Guided Imagery vs Deep Breathing Exercises on Primary Pediatric Care Patients With Functional Gastrointestinal Pain Disorders (TCH Pediatric Pilot Award)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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