RuminationPhase 3NCT01576302
Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination
A Phase 3 study testing Diaphragmatic breathing and Muscle relaxation in people with Rumination, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rumination
- What is being tested?
- Diaphragmatic breathing and Muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Diagnosis of rumination by RomeIII criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Rumination
- Being tested
- Diaphragmatic breathing, Muscle relaxation
- Keywords
- Rumination
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathingBehavioural
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 relaxationBehavioural
Also called Relaxation training, Progressive Muscle Relaxation
Progressive passive muscle relaxation
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing | Experimental | Training in diaphragmatic breathing as response incompatible with rumination. Receives: Behavioral: Diaphragmatic breathing; Behavioral: Muscle relaxation |
| Muscle relaxation | Active comparator | 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 Receives: Behavioral: Muscle relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 1 month after intervention
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?
Measured: 3 months after intervention
Secondary outcomes (8)
Heath Care Utilization
How many healthcare visits would you estimate were related to rumination since you started the intervention?
Measured: 1 month after intervention
Short Health Anxiety Inventory (SHAI)
Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
Measured: 1 month post intervention
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
Measured: 1 month after intervention
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.
Measured: 1 month after intervention
Heath Care Utilization
How many healthcare visits would you estimate were related to rumination since you started the intervention?
Measured: 3 month after intervention
Short Health Anxiety Inventory (SHAI)
Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
Measured: 3 months post intervention
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
Measured: 3 months after intervention
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.
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RuminationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard J. Seime, Mayo Clinic
- Investigators
- Richard Seime, PhD, LP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576302
- Sponsor's protocol ID
- 11-008528
- Status last verified
- Dec 2014
- First submitted
- 9 Apr 2012
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination
- ClinicalTrials.gov ID
- NCT01576302
- Acronym / sponsor ID
- 11-008528
- Conditions
- Rumination
- Keywords
- Rumination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing | Experimental | Behavioral: Diaphragmatic breathing, Behavioral: Muscle relaxationTraining in diaphragmatic breathing as response incompatible with rumination. |
| Muscle relaxation | Active comparator | Behavioral: Muscle relaxationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age.
- Diagnosis of rumination by RomeIII criteria
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic breathingPatients 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). | Behavioural | Diaphragmatic breathing |
| Muscle relaxationAlso: Relaxation training, Progressive Muscle RelaxationProgressive passive muscle relaxation | Behavioural | Diaphragmatic breathing, Muscle relaxation |
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?
8 secondary outcomes
Heath Care Utilization
Time frame: 1 month after intervention
Short Health Anxiety Inventory (SHAI)
Time frame: 1 month post intervention
Sheehan Disability Scale (SDS)
Time frame: 1 month after intervention
Treatment adherence
Time frame: 1 month after intervention
Heath Care Utilization
Time frame: 3 month after intervention
Short Health Anxiety Inventory (SHAI)
Time frame: 3 months post intervention
Sheehan Disability Scale (SDS)
Time frame: 3 months after intervention
Treatment adherence
Time frame: 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Seime, PhD, LP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diaphragmatic breathing and Muscle relaxation in people with Rumination, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rumination Frequency assessed using Rome III Criteria (time frame: 1 month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.