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Clinical Trial 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05961995
Study type Interventional
Source Ohio State University
Contact Thangam Venkatesan, MD
Phone 614-293-6255
Email thangam.venkatesean@osumc.edu
Status Recruiting
Phase N/A
Start date June 6, 2022
Completion date January 2024

See also
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Completed NCT03434652 - Auricular Neurostimulation for Cyclic Vomiting Syndrome N/A
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Completed NCT03470181 - Applying Nutrient Drink Test in Understanding Pathophysiology of CVS
Completed NCT03295760 - Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children N/A
Terminated NCT05065567 - Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis Phase 2
Terminated NCT04721171 - Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome. N/A