Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-17 @ 2:14 PM
Study NCT ID:
NCT06596759
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2024-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragmatic Breathing for the Treatment of Bloating and Distension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mayo Bloating Questionnaire (MBQ) score', 'timeFrame': 'Baseline, 4 weeks', 'description': 'The Mayo Bloating Questionnaire is a 45-item questionnaire developed to measure the multiple symptom components of bloating and distension.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bloating']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of diaphragmatic breathing using the validated Mayo Bloating Questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred for breath testing for the indication of bloating.\n\nExclusion Criteria:\n\n* Not referred for breath testing for the indication of bloating.'}, 'identificationModule': {'nctId': 'NCT06596759', 'briefTitle': 'Diaphragmatic Breathing for the Treatment of Bloating and Distension', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Diaphragmatic Breathing for the Treatment of Bloating and Distension: a Prospective Pilot Study', 'orgStudyIdInfo': {'id': '24-002905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diaphragmatic Breathing', 'description': 'Patients will complete the Mayo Bloating Questionnaire (MBQ) before referral to a physical therapist for in diaphragmatic breathing (DB) techniques over a 30-minute session. The patient will be instructed to complete 5-10 minutes of diaphragmatic breathing twice a day for a period of 4 weeks. At the end of the 4-week follow up period, patients will repeat the MBQ and self-report their adherence to daily diaphragmatic breathing.', 'interventionNames': ['Behavioral: Diaphragmatic Breathing']}], 'interventions': [{'name': 'Diaphragmatic Breathing', 'type': 'BEHAVIORAL', 'description': 'REDCap will be used to administer the Mayo Bloating Questionnaire (MBQ) and collect self-reported compliance to diaphragmatic breathing (DB) exercises over a 4 week follow up period. After completion of the MBQ, the patient will be taught DB techniques by an individual physical therapist face to face over a 30-minute session. The patient will be instructed to complete 5-10 minutes of diaphragmatic breathing twice a day for a period of 4 weeks. Patients will receive a telephone call and electronic health record portal message to check progress and answer any questions. At the end of the 4-week follow up period, patients will repeat the MBQ and self-report their adherence to daily diaphragmatic breathing. The questionnaire will include prompts investigating perceived side effects and attitudes towards therapy, willingness to perform DB therapy, likelihood to attempt self-guided DB in the future, and if the participant would recommend the therapy to a friend.', 'armGroupLabels': ['Diaphragmatic Breathing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian E Lacy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Robert C Chase, MD', 'role': 'CONTACT', 'email': 'chase.robert@mayo.edu', 'phone': '904-953-2000'}], 'overallOfficials': [{'name': 'Brian E Lacy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brian Lacy', 'investigatorAffiliation': 'Mayo Clinic'}}}}