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Completed

NCT Number: NCT01576302

Comparison of Diaphragmatic Breathing and Muscle Relaxation for 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.

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Key information

Conditions

Rumination Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Rumination Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diaphragmatic breathing

Behavioral

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

Behavioral

Progressive passive muscle relaxation

Other names: Relaxation training, Progressive Muscle Relaxation

Primary outcomes

  1. 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?

  2. 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?

Secondary outcomes

  1. 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?

  2. 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

  3. 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

  4. 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.

  5. 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?

  6. 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

  7. 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

  8. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 12, 2012
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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