Heartfulness Meditation Cyclic Vomiting Syndrome

Cyclic Vomiting Syndrome Clinical Trial

— HFN in CVS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961995
• Other study ID #: 2022H0078
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: January 2024

Study information

• Verified date: April 2023
• Source: Ohio State University
• Contact: Thangam Venkatesan, MD
• Phone: 614-293-6255
• Email: thangam.venkatesean[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cyclic Vomiting Syndrome
• Syndrome
• Vomiting

Intervention

Behavioral:
• Heartfulness meditation
Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Correlate indices of ECSS with psychological state	Measure stat anxiety with State Trait Anxiety Inventory (STAI) tool	6 weeks
Primary	Correlate indices of ECSS with psychological state	Measure state mood with Profile of Mood States (POMS) tool	6 weeks
Secondary	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
Secondary	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
Secondary	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