Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

December 8, 2014 updated by: Richard J. Seime, Mayo Clinic

Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal 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 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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 18 years of age.
  2. Diagnosis of rumination by RomeIII criteria

Exclusion Criteria:

  1. Active alcohol or substance abuse
  2. Presence of a depressive disorder as measured by PHQ-9 score of 10 or above
  3. Presence of clinical significant anxiety disorder as measured by GAD-7 score of 10 or above.
  4. Severe levels of health focused anxiety as measured by SHAI score of 26 or above.
  5. Any medical, neurological, or psychiatric condition that would impair the ability to consent and carry out all study procedures.
  6. Any active psychosis or suicidality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diaphragmatic breathing
Training in diaphragmatic breathing as response incompatible with rumination.
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).
Progressive passive muscle relaxation
Other Names:
  • Relaxation training
  • Progressive Muscle Relaxation
ACTIVE_COMPARATOR: Muscle relaxation
Patients in this arm of study will be taught muscle relaxation as intervention for rumination, instructed in habit-reversal paradigm to use after eating food or if urge to ruminate
Progressive passive muscle relaxation
Other Names:
  • Relaxation training
  • Progressive Muscle Relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rumination Frequency assessed using Rome III Criteria
Time Frame: 1 month after intervention

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?

1 month after intervention
Rumination frequency assessed using Rome III Criteria
Time Frame: 3 months after intervention

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?

3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heath Care Utilization
Time Frame: 1 month after intervention
How many healthcare visits would you estimate were related to rumination since you started the intervention?
1 month after intervention
Short Health Anxiety Inventory (SHAI)
Time Frame: 1 month post intervention
Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
1 month post intervention
Sheehan Disability Scale (SDS)
Time Frame: 1 month after intervention
This is a measure of the impact of symptoms on Work, Family, and Social life. Uses a 10 point scale --with categories of mild,moderate severe
1 month after intervention
Treatment adherence
Time Frame: 1 month after intervention
Following question will be posed: Did you engage in the intervention as you were instructed at your training session? The responses will be categorized for themes.
1 month after intervention
Heath Care Utilization
Time Frame: 3 month after intervention
How many healthcare visits would you estimate were related to rumination since you started the intervention?
3 month after intervention
Short Health Anxiety Inventory (SHAI)
Time Frame: 3 months post intervention
Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
3 months post intervention
Sheehan Disability Scale (SDS)
Time Frame: 3 months after intervention
This is a measure of the impact of symptoms on Work, Family, and Social life. Uses a 10 point scale --with categories of mild,moderate severe
3 months after intervention
Treatment adherence
Time Frame: 3 months after intervention
Following question will be posed: Did you engage in the intervention as you were instructed at your training session? The responses will be categorized for themes.
3 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Richard Seime, PhD, LP, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

April 9, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (ESTIMATE)

April 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rumination

Clinical Trials on Diaphragmatic breathing

Subscribe