Recurrent Abdominal PainNCT00852878
The Treatment of Recurrent Abdominal Pain in Children
A study testing Biofeedback and Behavioral Protocol in people with Recurrent Abdominal Pain, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Recurrent Abdominal Pain
- What is being tested?
- Biofeedback and Behavioral Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2010
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- who speak English
- diagnosis with Recurrent abdominal pain
Who cannot join
- lactose intolerance, urinary tract infections, or recent head trauma;
- the use of prescribed or over he counter medications, which may interfere with the biofeedback data;
- currently receiving other treatment for recurrent abdominal pain;
- the receipt of a recent and related surgical procedure;
- children who met criteria for depression or anxiety disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Vandever Medical Offices
San Diego, California, 92120
About this study
Official title: The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention
The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.
Read the detailed description
Recurrent abdominal pain (RAP) is a functional disorder that affects approximately 10 to 25% of children in the United States. This population tends to be heavy medical users in a search of a treatment for the chronic pain, but at this time there is no standard treatment protocol. The literature proposes that there are two effective treatments for RAP, a relaxation protocol by Sanders et al. (1994) and a biofeedback protocol currently in use at Kaiser, but neither treatment has been widely accepted as standard treatment. A purpose of this study is to gather more data on both treatments to help move one or both treatments into the standard of care for RAP. The hypothesis of this study is that the biofeedback and the relaxation protocols will have equivalent treatment outcomes.
- Conditions
- Recurrent Abdominal Pain
- Being tested
- Biofeedback, Behavioral Protocol
- Keywords
- Recurrent Abdominal Pain, Biofeedback, Heart Rate Variability
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
Also called resonant frequency breathing
Biofeedback will teach resonant frequency breathing for 6-8 sessions
Behavioral ProtocolBehavioural
Also called relaxation, distraction, and coping statements
Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Active comparator | heart rate variability biofeedback Receives: Behavioral: Biofeedback |
| Behavioral | Active comparator | Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements Receives: Behavioral: Behavioral Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy
Measured: 3 Months
Secondary outcomes (1)
A measurable secondary outcome will be changes in heart rate variability
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010 (estimated)
Why it stopped: Not enough interested participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Abdominal PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren L Shapiro, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852878
- Sponsor's protocol ID
- KPSC IRB #5275
- Status last verified
- Dec 2010
- First submitted
- 26 Feb 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention
- ClinicalTrials.gov ID
- NCT00852878
- Acronym / sponsor ID
- KPSC IRB #5275
- Conditions
- Recurrent Abdominal Pain
- Keywords
- Recurrent Abdominal Pain, Biofeedback, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough interested participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (estimated)
- First posted
- 27 Feb 2009 (estimated)
- 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 two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.
Detailed description
Recurrent abdominal pain (RAP) is a functional disorder that affects approximately 10 to 25% of children in the United States. This population tends to be heavy medical users in a search of a treatment for the chronic pain, but at this time there is no standard treatment protocol. The literature proposes that there are two effective treatments for RAP, a relaxation protocol by Sanders et al. (1994) and a biofeedback protocol currently in use at Kaiser, but neither treatment has been widely accepted as standard treatment. A purpose of this study is to gather more data on both treatments to help move one or both treatments into the standard of care for RAP. The hypothesis of this study is that the biofeedback and the relaxation protocols will have equivalent treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Active comparator | Behavioral: Biofeedbackheart rate variability biofeedback |
| Behavioral | Active comparator | Behavioral: Behavioral ProtocolBehavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- who speak English
- diagnosis with Recurrent abdominal pain
Key exclusion criteria (5 listed)
- lactose intolerance, urinary tract infections, or recent head trauma;
- the use of prescribed or over he counter medications, which may interfere with the biofeedback data;
- currently receiving other treatment for recurrent abdominal pain;
- the receipt of a recent and related surgical procedure;
- children who met criteria for depression or anxiety disorder
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 |
|---|---|---|
| BiofeedbackAlso: resonant frequency breathingBiofeedback will teach resonant frequency breathing for 6-8 sessions | Behavioural | Biofeedback |
| Behavioral ProtocolAlso: relaxation, distraction, and coping statementsBehavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions | Behavioural | Behavioral |
Primary outcome
The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy
Time frame: 3 Months
1 secondary outcome
A measurable secondary outcome will be changes in heart rate variability
Time frame: 3 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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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.
Warren L Shapiro, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback and Behavioral Protocol in people with Recurrent Abdominal Pain, run by Kaiser Permanente 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 5 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: withdrawn, as of the sponsor's last update on 23 Jun 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy (time frame: 3 Months). 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 23 Jun 2015.