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N/A N=45 Supportive Care

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

Cyclic Vomiting Syndrome

Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS) — 34.59; 35.05; 26.27; 41.67 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Heartfulness meditation (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Ohio State University
Primary completion
Jan 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
34.59; 35.05; 26.27; 41.67; 39.76; 36.10
SECONDARY
Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score
57.86; 55.68; 54.21; 46.63; 46.89; 49.87

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.

Eligibility Criteria

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 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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05961995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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