Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

Rumination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576302
• Other study ID #: 11-008528
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2012
• Last updated: December 8, 2014
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rumination

Intervention

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).
• Muscle relaxation
Progressive passive muscle relaxation

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	1 month after intervention	No
Primary	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?	3 months after intervention	No
Secondary	Heath Care Utilization	How many healthcare visits would you estimate were related to rumination since you started the intervention?	1 month after intervention	No
Secondary	Short Health Anxiety Inventory (SHAI)	Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure	1 month post intervention	No
Secondary	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	1 month after intervention	No
Secondary	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.	1 month after intervention	No
Secondary	Heath Care Utilization	How many healthcare visits would you estimate were related to rumination since you started the intervention?	3 month after intervention	No
Secondary	Short Health Anxiety Inventory (SHAI)	Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure	3 months post intervention	No
Secondary	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	3 months after intervention	No
Secondary	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.	3 months after intervention	No