CompletedNot Applicable

Heartfulness Meditation (HFM) in Cyclic Vomiting Syndrome (CVS)

United States45 participantsStarted 2022-06-06

Plain-language 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 stress exposure. This may reflect an underlying dysfunction of the ECSS in CVS and impaired stress responsivity. Given these data and our preliminary findings of the beneficial effects of HFN meditation, our central hypothesis is that HFN meditation will increase circulating endocannabinoids in CVS and that this will be correlated with a reduction in anxiety and other psychological outcomes and overall quality of life. We propose to test our hypothesis with the following specific aims Specific Aim 1a: 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. 1b: Correlate indices of ECSS with state anxiety and mood pre-and post-HFN meditation. We will measure state anxiety and mood with validated tools including the State Trait Anxiety Inventory (STAI) and Profile of Mood States (POMS) which evaluates tension, depression, anger, vigor, fatigue, and confusion. Hypothesis: HFN meditation will acutely increase circulating endocannabinoids which will be correlated with a reduction in state anxiety and improvement in mood. Specific Aim 2: Determine the long-term effects of a 6-week HFN meditation program on ECSS and correlate with psychological outcomes including psychological distress, STAI scores, sleep quality, and HRQoL. We will measure these outcomes with validated tools including the Brief Symptom Inventory (BSI), STAI, Pittsburgh Sleep Quality Index (PSQI), and PROMIS quality of life questionnaires. Hypothesis: A regular HFN meditation practice over 6 weeks will further augment ECSS, and this will be correlated with an improvement in psychological outcomes such as psychological distress, sleep, mood and HRQoL.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18 - 80 years of age * Diagnosed with CVS based on Rome criteria Exclusion Criteria: * Major psychiatric illness such as schizophrenia, bipolar disease, and major depression or anxiety that is not controlled with medication or requiring inpatient care within the past year * History of suicidal attempt/ideation in the past year * Cognitive impairment that precludes the ability to meditate * Inability to sit for at least 30 minutes * Severe cardiopulmonary diseases, malignancy, or renal failure on dialysis * Other organic gastrointestinal diseases or systemic diseases including but not limited to inflammatory bowel disease and chronic liver diseases * Pregnancy at the time of enrollment * BMI \< 18 or \>35 * Regular cannabis use (defined as daily or near-daily cannabis use) and * Individuals with significant prior meditation experience (continuous meditation practice for ≥ 3 months within a year prior to the study).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)

Timeframe: 6 weeks

Trial details

NCT IDNCT05961995

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

Results submitted2024-04-22

View on ClinicalTrials.gov More Cyclic Vomiting Syndrome trials