Gastric motility rhythms response to heart rate variability biofeedback interventions

Not Applicable

Recruiting

• Conditions: functional dyspepsia; chronic nausea and vomiting syndrome; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000691549
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-30
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Eligible participants must be at least 16 years old and meet Rome IV criteria for Functional Gastrointestinal Disorders (FGIDs), specifically limited to the upper gastrointestinal tract. This includes functional dyspepsia and chronic nausea and vomiting disorders or both if they meet criteria for both. Participants who also meet Rome IV criteria for disorders outside of the upper gastrointestinal system (i.e. irritable bowel syndrome) alongside their upper gastrointestinal disorder will not be excluded from the study. Participants must also be fluent in English and able to fully understand the risks and benefits of the research process.

Exclusion Criteria

Individuals who have chronic gastrointestinal disorders and/or a history of gastrointestinal surgery will be excluded. Females who are pregnant and/or lactating will also be excluded. Participants who have a history of cardiac disease, arrhythmia, beta blockers, calcium channel blockers or other cardiac rate-control drugs will also be excluded.

Patients will be required to sit in a reclined position for the duration of the study and so participants who are not able to do so will be excluded from the study.

The adhesive array of electrodes used as part of the BSGM test has a slight risk of irritation post-removal (incidence rate 1-2%). Thus, participants who are susceptible to skin abrasions, tears and bruises as well as participants with allergies to adhesives will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified