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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). 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.
Primary Outcome
Study participants will be treated with diaphragmatic breathing in one arm and muscle relaxation in the other arm. Outcome measure is: Rome III Study Questions Q8: In the last week, how often did food come back up into your mouth? Q10: When food came back up into your mouth, did it usually stay in your mouth for a while before you swallowed it or spit it out?
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 |
What the finished NCT01576302 record still lists
NCT01576302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Diaphragmatic breathing is the first listed.
NCT01576302 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01576302's enrollment target sits among peer trials
13 1984th of 2000 higher than 17 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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