Clinical Trial: Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination
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.
Detailed Summary:
Sponsor: Mayo Clinic
Current Primary Outcome:
- 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?
- 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?
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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?
- 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
- 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
- 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.
- 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?
- 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
- 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
- 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.
Original Secondary Outcome:
- 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?
- Short Health Anxiety Inventory (SHAI) [ Time Frame: 1 month post intevention ]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 ]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 ]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 ]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 ]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 ]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 ]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.
Information By: Mayo Clinic
Dates:
Date Received: April 9, 2012
Date Started: April 2012
Date Completion:
Last Updated: December 8, 2014
Last Verified: December 2014
