Clinical trial NCT03100487: Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Functional Gastrointestinal Disorders
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in abdominal pain symptoms
timeFrame: Change from Baseline to 8 weeks post-treatment
Secondary outcomes:
measure: Improvement in health-related quality of life
timeFrame: Change from Baseline to 8 weeks post-treatment
measure: Change in Psychosocial Distress
timeFrame: Change from Baseline to 8 weeks post-treatment
measure: Adherence to Intervention
timeFrame: 8 weeks after treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: John M Hollier, MD
role: PRINCIPAL_INVESTIGATOR
References: