Heartfulness Meditation Cyclic Vomiting Syndrome (HFN in CVS)

Heartfulness Meditation: Acute and Long-term Effects on the Endocannabinoid Signaling System and Correlation With Psychological Outcomes in Cyclic Vomiting Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Cyclic Vomiting Syndrome
• Intervention / Treatment: Behavioral: Heartfulness meditation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thangam Venkatesan, MD; Phone Number: 614-293-6255; Email: thangam.venkatesean@osumc.edu
• Study Contact Backup: Name: Kebire Gofar, MD, MPH; Phone Number: 614-293-8400; Email: kebire.gofar@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Thangam Venkatesan, MD; Phone Number: 614-293-6255; Email: thangam.venkatesan@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFN Meditation; Subjects will complete guided meditation sessions 3 x a week for six weeks delivered in the app via video, as well as pre- and post-meditation psychological state assessments.	Behavioral: Heartfulness meditation; Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute physiological effects of HFN Meditation on the endocannabinoid signaling system (ECSS)	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.	6 weeks
Correlate indices of ECSS with psychological state	Measure stat anxiety with State Trait Anxiety Inventory (STAI) tool	6 weeks
Correlate indices of ECSS with psychological state	Measure state mood with Profile of Mood States (POMS) tool	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes	Measure psychological distress using Brief Symptom Inventory (BSI) questionnaire	6 weeks
Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes	Measure sleep quality using Pittsburgh Sleep Quality Index (PSQI) questionnaire	6 weeks
Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes	Measure Health-related quality of life (HRQOL) using Patient-Reported Outcomes Measurement Information System (PROMIS) quality of life questionnaire	6 weeks

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Signs and Symptoms, Digestive; Syndrome; Vomiting
• Other Study ID Numbers: 2022H0078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No