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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: Completed NA study, sponsored by Ohio State University.
NCT05961995 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The primary outcomes were state and trait anxiety and mood states, measured using the State-Trait-Anxiety Inventory (STAI) and Profile of Mood States (POMS) respectively. The STAI-S evaluates current feelings of apprehension, tension, nervousness, and worry. The scale consists of two 20-item subscales and four rating categories including very much so, moderately so, somewhat and not at all. Scores for STAI range from 20 to 80. Higher scores indicate great anxiety, lower scores indicate no or low
Interventions
- BEHAVIORAL Heartfulness meditation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-06-06 |
| Est. Completion | 2024-01-01 |
| Phase | NA |
What the finished NCT05961995 record still lists
NCT05961995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Heartfulness meditation is the first listed.
NCT05961995 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05961995's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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