Efficacy of Audio Recorded Guided Imagery vs Deep Breathi... | NCT03100487

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

NCT03100487

Sponsor

Baylor College of Medicine

Status

Completed

Last Update Posted

Sep 21, 2023Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Abdominal Pain
Functional Gastrointestinal Disorders

Interventions

Apple iPod Shuffle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016Actual

Primary Completion Date

Sep 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Jan 19, 2017

First Submission Date that Met QC Criteria

Mar 29, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2023

Last Update Posted Date

Sep 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Hollier, Assistant Professor, Pediatrics-Gastroenterology, Baylor College of MedicinePrincipal Investigator

Lead Sponsor

Baylor College of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in abdominal pain symptoms	Abdominal Pain Index	Change from Baseline to 8 weeks post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Improvement in health-related quality of life	Pediatric Quality of Life Inventory (Peds QL) Questionnaire	Change from Baseline to 8 weeks post-treatment
Change in Psychosocial Distress	Behavior Assessment System for Children (BASC 3) Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John M Hollier, MD	Baylor College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Children's Hospital		Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015746	Abdominal Pain
D005767	Gastrointestinal Diseases

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided