Functional Abdominal PainPhase 3NCT00327548
Use of Guided Imagery for Functional Abdominal Pain in Children:
A Phase 3 study testing guided imagery in people with Functional Abdominal Pain, run by Children's Mercy Hospital Kansas City.
Trial summary
The purpose of the study is to evaluate the effectiveness of relaxation, with or without guided imagery, for treating children with functional abdominal pain. The study will evaluate a child's ability to decrease the amount of pain with these techniques to allow continuation of normal daily activities at home and at… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Functional Abdominal Pain
- What is being tested?
- guided imagery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 5 to 18 years
- All sexes
- Child, Adult
Who may be able to join
- at least 3 episodes of abdominal pain over the previous 3 months normal complete blood count, sedimentation rate, urinalysis stable on current medications English speaking -
Who cannot join
- unwillingness to participate chronic gastrointestinal disease cognitive-developmental delay major dissociative disorder
- -
About this study
Official title: Treatment of Functional Abdominal Pain in Children:Evaluation of Relaxation/Guided Imagery and Chamomile Tea as Therapeutic Modalities
The purpose of the study is to evaluate the effectiveness of relaxation, with or without guided imagery, for treating children with functional abdominal pain. The study will evaluate a child's ability to decrease the amount of pain with these techniques to allow continuation of normal daily activities at home and at school. The hypothesis is that these relaxation techniques will help decrease reports of abdominal pain and improve levels of activity.
- Conditions
- Functional Abdominal Pain
- Being tested
- guided imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided imageryBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pain
number of days of pain
missed activities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Investigators
- Fayez K Ghishan, MD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327548
- Sponsor's protocol ID
- NIH 5P50-AT00008
- Status last verified
- Jul 2002
- First submitted
- 16 May 2006
- Last updated
- 5 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Functional Abdominal Pain in Children:Evaluation of Relaxation/Guided Imagery and Chamomile Tea as Therapeutic Modalities
- ClinicalTrials.gov ID
- NCT00327548
- Acronym / sponsor ID
- NIH 5P50-AT00008
- Conditions
- Functional Abdominal Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Arizona
- First posted
- 18 May 2006 (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 the study is to evaluate the effectiveness of relaxation, with or without guided imagery, for treating children with functional abdominal pain. The study will evaluate a child's ability to decrease the amount of pain with these techniques to allow continuation of normal daily activities at home and at school. The hypothesis is that these relaxation techniques will help decrease reports of abdominal pain and improve levels of activity.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- at least 3 episodes of abdominal pain over the previous 3 months normal complete blood count, sedimentation rate, urinalysis stable on current medications English speaking -
Key exclusion criteria (2 listed)
- unwillingness to participate chronic gastrointestinal disease cognitive-developmental delay major dissociative 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 |
|---|---|---|
| guided imagery | Behavioural | – |
Primary outcome
Level of pain
number of days of pain
missed activities
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 5 Oct 2006.
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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.
Fayez K Ghishan, MD study chair
University of Arizona
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing guided imagery in people with Functional Abdominal Pain, run by Children's Mercy Hospital Kansas City.
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 1 inclusion and 2 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 5 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Level of pain. The study lists 3 primary outcomes in all. 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 5 Oct 2006.