Abdominal Pain, Functional Gastrointestinal Disorders
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEApple iPod Shuffle
One session at least 5 days a week for a total of 8 weeks
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Children who meet criteria for a functional gastrointestinal pain disorder. 2. Children who manage their abdominal pain in the primary care setting.
Exclusion criteria
1. Children who have other comorbidities that are associated with chronic abdominal pain including abdominal surgery and other medical diagnoses that can cause chronic abdominal pain. 2. Children with an intellectual disability which would hamper their ability to communicate with study staff about their pain and complete study questionnaires. 3. Children who have presented to a gastroenterologist for abdominal pain management 4. Children who have previously used deep breathing exercises or guided imagery to manage their abdominal pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in abdominal pain symptoms | Change from Baseline to 8 weeks post-treatment | Abdominal Pain Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in health-related quality of life | Change from Baseline to 8 weeks post-treatment | Pediatric Quality of Life Inventory (Peds QL) Questionnaire |
| Change in Psychosocial Distress | Change from Baseline to 8 weeks post-treatment | Behavior Assessment System for Children (BASC 3) Questionnaire |
| Adherence to Intervention | 8 weeks after treatment | Count of Number of Sessions Played |
Countries
United States
Outcome results
None listed