Diaphragmatic Breathing for the Treatment of Bloating and Distension

NCT06596759 | Recruiting

• 1 other identifier: 24-002905
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bloating

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diaphragmatic Breathing

EXPERIMENTAL

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

Interventions

Diaphragmatic Breathing BEHAVIORAL

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.

Diaphragmatic Breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred for breath testing for the indication of bloating.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Study Officials

• Brian E Lacy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert C Chase, MD

CONTACT

904-953-2000; chase.robert@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 21, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)