- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03100487
Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders
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)
The purpose of this study is to:
- 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.
- 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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Texas Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children who meet criteria for a functional gastrointestinal pain disorder.
- Children who manage their abdominal pain in the primary care setting.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Audio Record Guided Imagery (ARGI)
The audio recorded guided imagery sessions (treatment) will be delivered through a digital audio player (Apple iPod Shuffle).
|
One session at least 5 days a week for a total of 8 weeks
|
Experimental: Deep Breathing Exercises
The deep breathing exercises (control) will be delivered through a digital audio player (Apple iPod Shuffle).
|
One session at least 5 days a week for a total of 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in abdominal pain symptoms
Time Frame: Change from Baseline to 8 weeks post-treatment
|
Abdominal Pain Index
|
Change from Baseline to 8 weeks post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in health-related quality of life
Time Frame: Change from Baseline to 8 weeks post-treatment
|
Pediatric Quality of Life Inventory (Peds QL) Questionnaire
|
Change from Baseline to 8 weeks post-treatment
|
Change in Psychosocial Distress
Time Frame: Change from Baseline to 8 weeks post-treatment
|
Behavior Assessment System for Children (BASC 3) Questionnaire
|
Change from Baseline to 8 weeks post-treatment
|
Adherence to Intervention
Time Frame: 8 weeks after treatment
|
Count of Number of Sessions Played
|
8 weeks after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John M Hollier, MD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-39390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Pain
-
Lawson Health Research InstituteUniversity of Western Ontario, CanadaCompletedFunctional Gastrointestinal Disorders | Functional Abdominal Pain Syndrome | Abdominal Pain (AP)
-
Duke UniversityUnknown
-
Children's Mercy Hospital Kansas CityUniversity of ArizonaCompletedFunctional Abdominal Pain
-
University of WashingtonUniversity of North Carolina; MultiCare Mary Bridge Children's Hospital & Health...Completed
-
University of MichiganTerminatedFunctional Abdominal PainUnited States
-
University of BariClinica PEdiatrica Ospedale San Paolo Bari ItalyCompletedFunctional Abdominal PainItaly
-
National Center for Complementary and Integrative...CompletedRecurrent Abdominal PainUnited States
-
Jacques E. ChellyNational Institute on Drug Abuse (NIDA); Masimo CorporationRecruitingOpioid Use | Cancer Pain | Auriculotherapy | Pain, AbdominalUnited States
-
Michigan State UniversitySpectrum Health HospitalsWithdrawnFunctional Abdominal Pain SyndromeUnited States
-
Region Örebro CountyÖrebro University, SwedenActive, not recruitingFunctional Abdominal Pain | IBSSweden
Clinical Trials on Apple iPod Shuffle
-
University of Dublin, Trinity CollegeUnknown
-
Duke UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedChronic Pain | Posttraumatic Stress Disorders | Traumatic Brain InjuryUnited States
-
Hunter Holmes Mcguire Veteran Affairs Medical CenterCompleted
-
Pace UniversityEmory UniversityNot yet recruitingDepressive Disorder | Stroke, Acute | Movement, Abnormal | Expressive Aphasia
-
Duke UniversityNational Institute of Nursing Research (NINR)CompletedFeasibility of a Stigma Reduction Intervention for Human Immunodeficiency Virus (HIV)-Infected WomenHuman Immunodeficiency Virus (HIV) | Self-esteem | Self-efficacyUnited States
-
Clinical Nutrition Research Center, Illinois Institute...Completed
-
Maastricht University Medical CenterActive, not recruiting
-
The University of Texas Medical Branch, GalvestonCompleted
-
Clinical Research Center Kiel GmbHNofimaCompleted