Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01576302 · ClinicalTrials.gov registry record · Phase 3
Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
NCT01576302: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT01576302 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01576302, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
Study Summary
Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent regurgitation of recently ingested food. Very little is understood about the nature and treatment of this disorder. The act of regurgitation in rumination involves the opening of the upper esophageal sphincter and the muscular contraction of the abdomins rectus. Behavioral treatment of these symptoms is the clinical intervention of choice; however, only uncontrolled case documentation exists to support its effectiveness. However, an effective behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular relaxation is incompatible with the necessary muscular contraction for rumination. To date, single case documentation and few designed single case studies have examined the clinical effectiveness of behavioral interventions for GI rumination. In the current study, the investigators seek to examine the effectiveness of two behavioral relaxation interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our primary goals are to examine the clinical effectiveness of these interventions in symptom reduction at 1- and 3-month follow-up.
Interventions
- BEHAVIORAL Diaphragmatic breathing
- BEHAVIORAL Muscle relaxation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01576302
The ClinicalTrials.gov registry entry for NCT01576302 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Diaphragmatic breathing is the first listed.
NCT01576302 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01576302 about?
NCT01576302 is a clinical study titled "Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination". Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent regurgitation of recently ingested food. Very little is understood about the nature and treatment of this disorder. The act of regurgitation in rumination involves the opening of the upper esophageal sphincter and th...
What is the current status of trial NCT01576302?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2012-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01576302?
The interventions under investigation include: Diaphragmatic breathing (BEHAVIORAL), Muscle relaxation (BEHAVIORAL).
Who is sponsoring clinical trial NCT01576302?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.