Abdominal PainNCT00124501
Effectiveness of Biofeedback-Assisted Relaxation Training in Children With Eosinophilic Duodenitis
A study testing Biofeedback-assisted relaxation training in people with Abdominal Pain and Duodenitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the addition of Biofeedback-Assisted Relaxation to standard medication treatment improves outcomes for children with a specific type of recurrent abdominal pain (i.e., eosinophilic gastroenteritis). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Abdominal Pain, Duodenitis
- What is being tested?
- Biofeedback-assisted relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Aug 2006
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A current diagnosis of eosinophilic duodenitis per biopsy.
- Ability to participate in the biofeedback training protocol.
- Transportation available to attend twice weekly visits to Children's Mercy Hospital (CMH).
Who cannot join
- Previous biofeedback training.
- Previous failure of medications used as standard of care in this study.
- Allergy to medications prescribed in this study.
- Co-morbid chronic illness requiring regular medical care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: The Impact of Biofeedback-Assisted Relaxation Training on Pain and Functional Disability in Children Diagnosed With Eosinophilic Duodenitis: Pilot Study
The purpose of this study is to determine whether the addition of Biofeedback-Assisted Relaxation to standard medication treatment improves outcomes for children with a specific type of recurrent abdominal pain (i.e., eosinophilic gastroenteritis).
Read the detailed description
Recurrent abdominal pain (RAP) is the most common type of pain in school age children and young adolescents. Previous studies suggest that stress plays an important role in the activation of specific cells that can produce pain within the stomach and intestines. Medication is the standard approach to the treatment of RAP in children. Although medication is helpful for many children, medication alone is not always enough. Biofeedback trains individuals to use relaxation strategies effectively to relieve emotional and physical symptoms, and has been used successfully for stress and pain reduction with both children and adults. It has shown promising results when used alone in the treatment of children with RAP. Research is needed, however, to determine whether biofeedback training is helpful when used in conjunction with medication. Information about how biofeedback training affects the central nervous system and the cells that produce pain also would be useful in refining treatments for this large group of children. The current research will be done in three steps, with Phase 1 designed to evaluate the time, resources, technical support, and sample size needed for successful completion of the full research study. Twenty children (ages 8-18) with eosinophilic duodenitis, a specific form of RAP, will be enrolled and randomly assigned to one of two groups: 1) Standard of Care; or 2) Biofeedback (standard medical care plus 10 sessions of biofeedback training). Measures of pain, functional disability, quality of life, physiological arousal, and global treatment response will be collected pre- and post-intervention, as well as 3 and 6 months later. Data collected will be used to determine how many participants will be needed for the full research study. If biofeedback training is ultimately found to be a positive addition to standard medical treatment, this could lead to improved health outcomes for children with RAP. This information also could result in greater treatment efficiency and reduced health care costs for families, insurance providers, and the hospital system.
- Conditions
- Abdominal Pain, Duodenitis
- Being tested
- Biofeedback-assisted relaxation training
- Keywords
- Biofeedback
- Medical subject headings
- Abdominal Pain, Duodenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback-assisted relaxation trainingBehavioural
10 sessions BART
| Study group | Role | What they receive |
|---|---|---|
| SMT | Active comparator | Standard Medication Treatment Receives: Behavioral: Biofeedback-assisted relaxation training |
| BART | Experimental | Biofeedback-assisted Relaxation Training plus SMT Receives: Behavioral: Biofeedback-assisted relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection)
Measured: Up to 6 months
Secondary outcomes (4)
Functional disability rating scale at 6 weeks, 3 months, and 6 months
Measured: 6 weeks, 3 months, and 6 months
Pain ratings on daily diary, at 6 weeks, 3 months, and 6 months
Measured: 6 weeks, 3 months, and 6 months
Changes in salivary cortisol at 6 weeks, 3 months, and 6 months
Measured: 6 weeks, 3 months, and 6 months
Changes in other psychosocial measures (e.g., Behavior Assessment System for Children (BASC), sleep survey, quality of life, etc.) at 6 weeks, 3 months, and 6 months
Measured: 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startOct 2004
- Primary completionAug 2006
- Study completionAug 2006
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.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Jennifer V Schurman, Ph.D., Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124501
- Sponsor's protocol ID
- 00003103
- Status last verified
- May 2008
- First submitted
- 26 Jul 2005
- Last updated
- 30 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Biofeedback-Assisted Relaxation Training on Pain and Functional Disability in Children Diagnosed With Eosinophilic Duodenitis: Pilot Study
- ClinicalTrials.gov ID
- NCT00124501
- Acronym / sponsor ID
- 00003103
- Conditions
- Abdominal Pain, Duodenitis
- Keywords
- Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 28 Jul 2005 (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 whether the addition of Biofeedback-Assisted Relaxation to standard medication treatment improves outcomes for children with a specific type of recurrent abdominal pain (i.e., eosinophilic gastroenteritis).
Detailed description
Recurrent abdominal pain (RAP) is the most common type of pain in school age children and young adolescents. Previous studies suggest that stress plays an important role in the activation of specific cells that can produce pain within the stomach and intestines. Medication is the standard approach to the treatment of RAP in children. Although medication is helpful for many children, medication alone is not always enough. Biofeedback trains individuals to use relaxation strategies effectively to relieve emotional and physical symptoms, and has been used successfully for stress and pain reduction with both children and adults. It has shown promising results when used alone in the treatment of children with RAP. Research is needed, however, to determine whether biofeedback training is helpful when used in conjunction with medication. Information about how biofeedback training affects the central nervous system and the cells that produce pain also would be useful in refining treatments for this large group of children. The current research will be done in three steps, with Phase 1 designed to evaluate the time, resources, technical support, and sample size needed for successful completion of the full research study. Twenty children (ages 8-18) with eosinophilic duodenitis, a specific form of RAP, will be enrolled and randomly assigned to one of two groups: 1) Standard of Care; or 2) Biofeedback (standard medical care plus 10 sessions of biofeedback training). Measures of pain, functional disability, quality of life, physiological arousal, and global treatment response will be collected pre- and post-intervention, as well as 3 and 6 months later. Data collected will be used to determine how many participants will be needed for the full research study. If biofeedback training is ultimately found to be a positive addition to standard medical treatment, this could lead to improved health outcomes for children with RAP. This information also could result in greater treatment efficiency and reduced health care costs for families, insurance providers, and the hospital system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMT | Active comparator | Behavioral: Biofeedback-assisted relaxation trainingStandard Medication Treatment |
| BART | Experimental | Behavioral: Biofeedback-assisted relaxation trainingBiofeedback-assisted Relaxation Training plus SMT |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- A current diagnosis of eosinophilic duodenitis per biopsy.
- Ability to participate in the biofeedback training protocol.
- Transportation available to attend twice weekly visits to Children's Mercy Hospital (CMH).
Key exclusion criteria (4 listed)
- Previous biofeedback training.
- Previous failure of medications used as standard of care in this study.
- Allergy to medications prescribed in this study.
- Co-morbid chronic illness requiring regular medical care.
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 |
|---|---|---|
| Biofeedback-assisted relaxation training10 sessions BART | Behavioural | BART, SMT |
Primary outcome
Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection)
Time frame: Up to 6 months
4 secondary outcomes
Functional disability rating scale at 6 weeks, 3 months, and 6 months
Time frame: 6 weeks, 3 months, and 6 months
Pain ratings on daily diary, at 6 weeks, 3 months, and 6 months
Time frame: 6 weeks, 3 months, and 6 months
Changes in salivary cortisol at 6 weeks, 3 months, and 6 months
Time frame: 6 weeks, 3 months, and 6 months
Changes in other psychosocial measures (e.g., Behavior Assessment System for Children (BASC), sleep survey, quality of life, etc.) at 6 weeks, 3 months, and 6 months
Time frame: 6 weeks, 3 months, and 6 months
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 30 May 2008.
Related trials for Abdominal Pain
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
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.
Jennifer V Schurman, Ph.D. principal investigator
Children's Mercy Hospital Kansas City
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-assisted relaxation training in people with Abdominal Pain and Duodenitis, run by Children's Mercy Hospital Kansas City 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 3 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 30 May 2008. 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?
Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection) (time frame: Up to 6 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 30 May 2008.