What side effects are associated with this type of intervention?

Common treatments for Cyclic Vomiting Syndrome (CVS) that focus on stress reduction and improved psychological outcomes include Heartfulness Meditation, cognitive-behavioral therapy (CBT), guided imagery, and hypnotherapy. These treatments generally have minimal side effects. Heartfulness Meditation and guided imagery are typically well-tolerated, with the most common side effects being mild and transient, such as temporary discomfort or emotional release during sessions. CBT and hypnotherapy may occasionally cause increased anxiety or emotional distress, particularly when addressing deep-seated psychological issues. Overall, these treatments are considered safe and beneficial for managing CVS symptoms and improving quality of life.

What prior FDA approvals exist?

Cyclic Vomiting Syndrome (CVS) is often managed through a combination of pharmacological and non-pharmacological treatments. While specific FDA-approved drugs for CVS are not detailed in the provided context, the management typically includes medications to control nausea and vomiting, such as antiemetics and prokinetics. Additionally, stress reduction techniques, such as Heartfulness Meditation, have shown promise in improving psychological outcomes and reducing the frequency of CVS episodes. This holistic approach aligns with the biopsychosocial model of care recommended for CVS, emphasizing the importance of addressing both physical and psychological aspects of the disorder.

What other types of research exist?

Promising, novel alternatives to Heartfulness Meditation for Cyclic Vomiting Syndrome patients include biofeedback-assisted relaxation training, guided imagery, and acupuncture. These techniques have shown efficacy in stress reduction and improving psychological outcomes in various clinical settings.

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Behavioral Intervention

Heartfulness Meditation for Cyclic Vomiting Syndrome (HFN in CVS Trial)

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

HFN in CVS Trial Summary

This trial examines a technique to reduce psychological distress and improve HRQoL in people with Cyclic Vomiting Syndrome. It suggests that Heartfulness Meditation may help reduce stress and improve well-being in those affected.

Who is the study for?

This trial is for adults aged 18-80 with Cyclic Vomiting Syndrome (CVS) as per Rome criteria. It's not suitable for those with severe heart/lung diseases, kidney failure on dialysis, recent suicidal behavior, cognitive issues preventing meditation, major uncontrolled psychiatric illnesses, inability to sit for 30 minutes, certain other health conditions or high/low BMI.Check my eligibility

What is being tested?

The study tests Heartfulness meditation—a free guided technique focusing on relaxation and the heart—to see if it reduces stress and improves quality of life in CVS patients. The effects of this meditation practice on psychological distress and coping strategies are also being studied.See study design

What are the potential side effects?

Heartfulness meditation is generally considered safe but may cause discomfort due to sitting still for long periods. Some individuals might experience increased emotional sensitivity or awareness during the process.

HFN in CVS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute physiological effects of HFN Meditation on the endocannabinoid signaling system (ECSS)

Correlate indices of ECSS with psychological state

Secondary outcome measures

Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes

HFN in CVS Trial Design

1Treatment groups

Experimental Treatment

Group I: HFN MeditationExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cyclic Vomiting Syndrome (CVS) include tricyclic antidepressants (TCAs) like amitriptyline, which modulate neurotransmitters to reduce stress and improve mood, and mitochondrial-targeted therapies like coenzyme Q10 and L-carnitine, which enhance cellular energy production and reduce oxidative stress. Treatments for autonomic dysfunction, such as those addressing postural orthostatic tachycardia syndrome (POTS), help balance the autonomic nervous system. These mechanisms are crucial for CVS patients as they address both psychological and physiological triggers, potentially reducing the frequency and severity of vomiting episodes.

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Who is running the clinical trial?

Ohio State UniversityLead Sponsor

837 Previous Clinical Trials

507,906 Total Patients Enrolled

Media Library

Heartfulness Meditation (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05961995 — N/A

Cyclic Vomiting Syndrome Research Study Groups: HFN Meditation

Cyclic Vomiting Syndrome Clinical Trial 2023: Heartfulness Meditation Highlights & Side Effects. Trial Name: NCT05961995 — N/A

Heartfulness Meditation (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05961995 — N/A

~14 spots leftby May 2025

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