Abdominal PainNCT03100487
Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders
A study testing Apple iPod Shuffle in people with Abdominal Pain and Functional Gastrointestinal Disorders, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Abdominal Pain, Functional Gastrointestinal Disorders
- What is being tested?
- Apple iPod Shuffle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who meet criteria for a functional gastrointestinal pain disorder.
- Children who manage their abdominal pain in the primary care setting.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- Apple iPod Shuffle
- Medical subject headings
- Abdominal Pain, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple iPod ShuffleDevice
One session at least 5 days a week for a total of 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Audio Record Guided Imagery (ARGI) | Experimental | The audio recorded guided imagery sessions (treatment) will be delivered through a digital audio player (Apple iPod Shuffle). Receives: Device: Apple iPod Shuffle |
| Deep Breathing Exercises | Experimental | The deep breathing exercises (control) will be delivered through a digital audio player (Apple iPod Shuffle). Receives: Device: Apple iPod Shuffle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abdominal pain symptoms
Abdominal Pain Index
Measured: Change from Baseline to 8 weeks post-treatment
Secondary outcomes (3)
Improvement in health-related quality of life
Pediatric Quality of Life Inventory (Peds QL) Questionnaire
Measured: Change from Baseline to 8 weeks post-treatment
Change in Psychosocial Distress
Behavior Assessment System for Children (BASC 3) Questionnaire
Measured: Change from Baseline to 8 weeks post-treatment
Adherence to Intervention
Count of Number of Sessions Played
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startAug 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Hollier, Baylor College of Medicine
- Investigators
- John M Hollier, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100487
- Sponsor's protocol ID
- H-39390
- Status last verified
- Sep 2023
- First submitted
- 19 Jan 2017
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03100487
- Acronym / sponsor ID
- H-39390
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audio Record Guided Imagery (ARGI) | Experimental | Device: Apple iPod ShuffleThe audio recorded guided imagery sessions (treatment) will be delivered through a digital audio player (Apple iPod Shuffle). |
| Deep Breathing Exercises | Experimental | Device: Apple iPod ShuffleThe deep breathing exercises (control) will be delivered through a digital audio player (Apple iPod Shuffle). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who meet criteria for a functional gastrointestinal pain disorder.
- Children who manage their abdominal pain in the primary care setting.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple iPod ShuffleOne session at least 5 days a week for a total of 8 weeks | Device | Audio Record Guided Imagery (ARGI), Deep Breathing Exercises |
Primary outcome
Change in abdominal pain symptoms
Time frame: Change from Baseline to 8 weeks post-treatment
Abdominal Pain Index
3 secondary outcomes
Improvement in health-related quality of life
Time frame: Change from Baseline to 8 weeks post-treatment
Change in Psychosocial Distress
Time frame: Change from Baseline to 8 weeks post-treatment
Adherence to Intervention
Time frame: 8 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Hollier, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple iPod Shuffle in people with Abdominal Pain and Functional Gastrointestinal Disorders, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in abdominal pain symptoms (time frame: Change from Baseline to 8 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.