Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Richard J. Seime, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01576302
First received: April 9, 2012
Last updated: May 2, 2014
Last verified: May 2014

April 9, 2012
May 2, 2014
April 2012
November 2014   (final data collection date for primary outcome measure)
  • Rumination Frequency assessed using Rome III Criteria [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]

    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?

Same as current
Complete list of historical versions of study NCT01576302 on ClinicalTrials.gov Archive Site
  • Heath Care Utilization [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    How many healthcare visits would you estimate were related to rumination since you started the intervention?
  • Short Health Anxiety Inventory (SHAI) [ Time Frame: 1 month post intervention ] [ Designated as safety issue: No ]
    Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
  • Sheehan Disability Scale (SDS) [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 month after intervention ] [ Designated as safety issue: No ]
    How many healthcare visits would you estimate were related to rumination since you started the intervention?
  • Short Health Anxiety Inventory (SHAI) [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]
    Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
  • Sheehan Disability Scale (SDS) [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    How many healthcare visits would you estimate were related to rumination since you started the intervention?
  • Short Health Anxiety Inventory (SHAI) [ Time Frame: 1 month post intevention ] [ Designated as safety issue: No ]
    Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
  • Sheehan Disability Scale (SDS) [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    Following question will be posed: Did you engage in the intervention as you were instructed at your training session? The reponses will be categorized for themes.
  • Heath Care Utilization [ Time Frame: 3 month after intervention ] [ Designated as safety issue: No ]
    How many healthcare visits would you estimate were related to rumination since you started the intervention?
  • Short Health Anxiety Inventory (SHAI) [ Time Frame: 3 months post intevention ] [ Designated as safety issue: No ]
    Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
  • Sheehan Disability Scale (SDS) [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
    Following question will be posed: Did you engage in the intervention as you were instructed at your training session? The reponses will be categorized for themes.
Not Provided
Not Provided
 
Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rumination
  • 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
    Other Names:
    • Relaxation training
    • Progressive Muscle Relaxation
  • Experimental: Diaphragmatic breathing
    Training in diaphragmatic breathing as response incompatible with rumination.
    Interventions:
    • Behavioral: Diaphragmatic breathing
    • Behavioral: 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
    Intervention: Behavioral: Muscle relaxation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United States
 
NCT01576302
11-008528
No
Richard J. Seime, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Richard Seime, PhD, LP Mayo Clinic
Mayo Clinic
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP