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NCT05961995 · ClinicalTrials.gov registry record · NA
Heartfulness Meditation (HFM) in Cyclic Vomiting Syndrome (CVS)
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT05961995 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 45 participants.
The verdict
NCT05961995, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study 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. The endocannabinoid signaling system (ECSS) is activated by stress exposure and functions through multiple neuroendocrine responses to mitigate the negative effects of stress. We examined the role of the ECSS in CVS and found that endocannabinoids were not elevated during an acute CVS episode. This lack of a response in the ECSS during an acute CVS episode, which is characterized by panic, intense nausea and vomiting is striking, given that the ECSS is typically activated by stres
Interventions
- BEHAVIORAL Heartfulness meditation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-06-06 |
| Est. Completion | 2024-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05961995
The ClinicalTrials.gov registry entry for NCT05961995 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Heartfulness meditation is the first listed.
NCT05961995 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05961995 about?
NCT05961995 is a clinical study titled "Heartfulness Meditation (HFM) in Cyclic Vomiting Syndrome (CVS)". 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 ...
What is the current status of trial NCT05961995?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2022-06-06. Estimated completion is 2024-01-01.
What interventions are being tested in trial NCT05961995?
The interventions under investigation include: Heartfulness meditation (BEHAVIORAL).
Who is sponsoring clinical trial NCT05961995?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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