Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination
Completed · Phase 3
Conditions studied: Rumination
In brief
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.
Key facts
- Study ID
- NCT01576302
- Run by
- Mayo Clinic
- People needed
- 13
- Starts
- 2012-04-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2014-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 18 years of age.
- Diagnosis of rumination by RomeIII criteria
You may not qualify if…
- Active alcohol or substance abuse
- Presence of a depressive disorder as measured by PHQ-9 score of 10 or above
- Presence of clinical significant anxiety disorder as measured by GAD-7 score of 10 or above.
- Severe levels of health focused anxiety as measured by SHAI score of 26 or above.
- Any medical, neurological, or psychiatric condition that would impair the ability to consent and carry out all study procedures.
- Any active psychosis or suicidality.
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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