Clinical Trial: Heartfulness Meditation Cyclic Vomiting Syndrome

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Heartfulness Meditation: Acute and Long-term Effects on the Endocannabinoid Signaling System and Correlation With Psychological Outcomes in Cyclic Vomiting Syndrome

Brief Summary:

Cyclic vomiting syndrome (CVS) is a chronic disorder of gut-brain interaction (DGBI) characterized by episodes of vomiting often triggered by stress.
CVS affects 2% of the population and has a disproportionate negative impact on patients and the healthcare system.
Although gastrointestinal symptoms are prominent, most patients have comorbid anxiety, depression, high degrees of psychological distress, and other negative cognitive traits that adversely affect health-related quality of life (HRQoL).
This is independent of typical measures of severity of CVS and warrants treatment.
Recent guidelines recommend a biopsychosocial model of care incorporating techniques like meditation to mitigate stress and improve psychological outcomes in CVS.
One potential approach to improve these outcomes is the use of heartfulness (HFN) meditation.

Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.
It is offered virtually and is free-of charge ensuring no barriers to broad application in clinical practice.
A pilot study incorporating HFN meditation in CVS significantly reduced psychological distress, perceived stress, and improved coping strategies, sleep quality, and HRQoL.
Other data also show that HFN meditation improves overall well-being and reduces perceived stress.
However, there are significant gaps in our understanding of the mechanism underlying HFN meditation and its effects on patient outcomes.

Detailed Summary:
Sponsor: Ohio State University

Current Primary Outcome: Conduct a prospective study to elucidate the acute effects of HFN meditation on the ECSS in CVS.
We will measure circulating endocannabinoids and related lipids immediately before and after HFN meditation.

Original Primary Outcome: Conduct a prospective study to elucidate the acute effects of HFN meditation on the ECSS in CVS.
We will measure circulating endocannabinoids and related lipids immediately before and after HFN meditation.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University

Dates:
Date Received: April 05, 2023
Date Started: June 06, 2022
Date Completion: January 01, 2024
Last Updated: July 18, 2023
Last Verified: April 01, 2023