Diaphragmatic Breathing for the Treatment of Bloating and Distension

Diaphragmatic Breathing for the Treatment of Bloating and Distension: a Prospective Pilot Study

The purpose of this study is to evaluate the efficacy of diaphragmatic breathing using the validated Mayo Bloating Questionnaire.

Study Overview

• Status: Recruiting
• Conditions: Bloating
• Intervention / Treatment: Behavioral: Diaphragmatic Breathing

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert C Chase, MD; Phone Number: 904-953-2000; Email: chase.robert@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Principal Investigator: Brian E Lacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Referred for breath testing for the indication of bloating.

Exclusion Criteria:

• Not referred for breath testing for the indication of bloating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diaphragmatic Breathing; 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.

Behavioral: Diaphragmatic Breathing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mayo Bloating Questionnaire (MBQ) score	The Mayo Bloating Questionnaire is a 45-item questionnaire developed to measure the multiple symptom components of bloating and distension.	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brian E Lacy, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 24-002905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No