Virtual Reality for Non-cardiac Chest Pain

NCT ID: NCT06262126

Last Updated: 2026-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).

Detailed Description

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The primary aim of this study is to assess the overall feasibility of virtual reality for the treatment of noncardiac chest pain and identify problems, issues, or challenges that may impact the performance of a future clinical trial. As such, the study will focus on willingness to participate, patient adherence, patient retention, and burdensomeness of the intervention and survey instruments. As a lesser objective, we will assess the effectiveness of virtual reality in patients with noncardiac chest pain at improving pain severity, symptom hypervigilance, anxiety, quality of life, and resilience.

Conditions

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Gastrointestinal Diseases Chest Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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VR Arm

Viritual Reality therapy arm. All patients will receive virtual reality therapy.

Group Type OTHER

Virtual Reality

Intervention Type OTHER

Virtual Reality therapy

Interventions

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Virtual Reality

Virtual Reality therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain)
* Negative prior cardiac evaluation (at a minimum, including electrocardiogram)
* Prior esophagogastroduodenoscopy and/or barium esophagram to rule out severe esophagitis, stricture, or motility abnormality

Exclusion Criteria

* Initiation of a proton pump inhibitor (PPI) within 8 weeks
* Major concomitant illness
* Current drug or alcohol use that that would interfere with adherence to study requirements
* Symptoms of vertigo or dizziness that would limit tolerability of the VR headset
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Andree H. Koop

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andree Koop, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Wendi Lehman

Role: primary

904-953-8742

Related Links

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Other Identifiers

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23-012673

Identifier Type: -

Identifier Source: org_study_id

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