Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders

Baylor College of Medicine

Status: Completed

Conditions: Functional Gastrointestinal Disorders; Abdominal Pain

Treatments: Device: Apple iPod Shuffle

Study type: Interventional

Funder types: Other

Identifiers

NCT03100487

H-39390

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Audio Record Guided Imagery (ARGI)

Experimental group

Description:

The audio recorded guided imagery sessions (treatment) will be delivered through a digital audio player (Apple iPod Shuffle).

Treatment:

Device: Apple iPod Shuffle

Deep Breathing Exercises

Experimental group

Description:

The deep breathing exercises (control) will be delivered through a digital audio player (Apple iPod Shuffle).

Treatment:

Device: Apple iPod Shuffle