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Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

NCT01576302 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2014-12-10

No results posted yet for this 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.

Conditions

  • Rumination

Interventions

BEHAVIORAL

Diaphragmatic breathing

Patients in this arm will be provided training in diaphragmatic breathing, taught its application in habit-reversal paradigm (to use after eating food and if urge to ruminate).

BEHAVIORAL

Muscle relaxation

Progressive passive muscle relaxation

Sponsors & Collaborators

Principal Investigators

  • Richard Seime, PhD, LP · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576302 on ClinicalTrials.gov