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Heartfulness Meditation Cyclic Vomiting Syndrome (HFN in CVS)

Primary Purpose

Cyclic Vomiting Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heartfulness meditation
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cyclic Vomiting Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HFN Meditation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Correlate indices of ECSS with psychological state
Measure stat anxiety with State Trait Anxiety Inventory (STAI) tool
Correlate indices of ECSS with psychological state
Measure state mood with Profile of Mood States (POMS) tool

Secondary Outcome Measures

Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes
Measure psychological distress using Brief Symptom Inventory (BSI) questionnaire
Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes
Measure sleep quality using Pittsburgh Sleep Quality Index (PSQI) questionnaire
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

Full Information

First Posted
April 5, 2023
Last Updated
July 18, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05961995
Brief Title
Heartfulness Meditation Cyclic Vomiting Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyclic Vomiting Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFN Meditation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Heartfulness meditation
Intervention Description
Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.
Primary Outcome Measure Information:
Title
Acute physiological effects of HFN Meditation on the endocannabinoid signaling system (ECSS)
Description
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.
Time Frame
6 weeks
Title
Correlate indices of ECSS with psychological state
Description
Measure stat anxiety with State Trait Anxiety Inventory (STAI) tool
Time Frame
6 weeks
Title
Correlate indices of ECSS with psychological state
Description
Measure state mood with Profile of Mood States (POMS) tool
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes
Description
Measure psychological distress using Brief Symptom Inventory (BSI) questionnaire
Time Frame
6 weeks
Title
Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes
Description
Measure sleep quality using Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame
6 weeks
Title
Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes
Description
Measure Health-related quality of life (HRQOL) using Patient-Reported Outcomes Measurement Information System (PROMIS) quality of life questionnaire
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 < 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thangam Venkatesan, MD
Phone
614-293-6255
Email
thangam.venkatesean@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kebire Gofar, MD, MPH
Phone
614-293-8400
Email
kebire.gofar@osumc.edu
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thangam Venkatesan, MD
Phone
614-293-6255
Email
thangam.venkatesan@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Heartfulness Meditation Cyclic Vomiting Syndrome

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