search
Back to results

Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

Primary Purpose

Rumination

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diaphragmatic breathing
Muscle relaxation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rumination focused on measuring Rumination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diaphragmatic breathing

Muscle relaxation

Arm Description

Training in diaphragmatic breathing as response incompatible with rumination.

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

Outcomes

Primary Outcome Measures

Rumination Frequency assessed using Rome III Criteria
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?
Rumination frequency assessed using Rome III Criteria
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?

Secondary Outcome Measures

Heath Care Utilization
How many healthcare visits would you estimate were related to rumination since you started the intervention?
Short Health Anxiety Inventory (SHAI)
Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
Sheehan Disability Scale (SDS)
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
Treatment adherence
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.
Heath Care Utilization
How many healthcare visits would you estimate were related to rumination since you started the intervention?
Short Health Anxiety Inventory (SHAI)
Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
Sheehan Disability Scale (SDS)
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
Treatment adherence
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.

Full Information

First Posted
April 9, 2012
Last Updated
December 8, 2014
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01576302
Brief Title
Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination
Official Title
Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rumination
Keywords
Rumination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic breathing
Arm Type
Experimental
Arm Description
Training in diaphragmatic breathing as response incompatible with rumination.
Arm Title
Muscle relaxation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Diaphragmatic breathing
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Muscle relaxation
Other Intervention Name(s)
Relaxation training, Progressive Muscle Relaxation
Intervention Description
Progressive passive muscle relaxation
Primary Outcome Measure Information:
Title
Rumination Frequency assessed using Rome III Criteria
Description
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?
Time Frame
1 month after intervention
Title
Rumination frequency assessed using Rome III Criteria
Description
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?
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
Heath Care Utilization
Description
How many healthcare visits would you estimate were related to rumination since you started the intervention?
Time Frame
1 month after intervention
Title
Short Health Anxiety Inventory (SHAI)
Description
Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
Time Frame
1 month post intervention
Title
Sheehan Disability Scale (SDS)
Description
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
Time Frame
1 month after intervention
Title
Treatment adherence
Description
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.
Time Frame
1 month after intervention
Title
Heath Care Utilization
Description
How many healthcare visits would you estimate were related to rumination since you started the intervention?
Time Frame
3 month after intervention
Title
Short Health Anxiety Inventory (SHAI)
Description
Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
Time Frame
3 months post intervention
Title
Sheehan Disability Scale (SDS)
Description
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
Time Frame
3 months after intervention
Title
Treatment adherence
Description
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.
Time Frame
3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age. Diagnosis of rumination by RomeIII criteria Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Seime, PhD, LP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

We'll reach out to this number within 24 hrs