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

NCT03100487 | Completed DMC

• 1 other identifier: H-39390
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 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. 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.

Conditions

Abdominal Pain; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• Change in abdominal pain symptoms

  Abdominal Pain Index

  Change from Baseline to 8 weeks post-treatment

Secondary Outcomes (3)

• Improvement in health-related quality of life

  Change from Baseline to 8 weeks post-treatment

• Change in Psychosocial Distress

  Change from Baseline to 8 weeks post-treatment

• Adherence to Intervention

  8 weeks after treatment

Study Arms (2)

Audio Record Guided Imagery (ARGI)

EXPERIMENTAL

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

Device: Apple iPod Shuffle

Deep Breathing Exercises

EXPERIMENTAL

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

Device: Apple iPod Shuffle

Interventions

Apple iPod Shuffle DEVICE

One session at least 5 days a week for a total of 8 weeks

Audio Record Guided Imagery (ARGI); Deep Breathing Exercises

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who meet criteria for a functional gastrointestinal pain disorder.
• Children who manage their abdominal pain in the primary care setting.

You may not qualify if:

• 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.
• Children with an intellectual disability which would hamper their ability to communicate with study staff about their pain and complete study questionnaires.
• Children who have presented to a gastroenterologist for abdominal pain management
• Children who have previously used deep breathing exercises or guided imagery to manage their abdominal pain.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Abdominal Pain; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Digestive System Diseases

Study Officials

• John M Hollier, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics-Gastroenterology

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: April 4, 2017
• Study Start: August 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)