Virtual Reality for Non-cardiac Chest Pain

NCT06262126 | Recruiting

• 1 other identifier: 23-012673
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastrointestinal Diseases; Chest Pain

Keywords

Virtual reality

Outcome Measures

Primary Outcomes (5)

• Measure changes in GERD symptoms using the GERDQ questionnare

  Gastroesophageal reflux disease (GERD) questionnaire (GerdQ) is a 6-item questionnaire (scale from 0 to 18) that measures heartburn, regurgitation, abdominal pain, nausea, sleep disorders, and the over-the-counter (OTC) drugs use. The score predicts the likelihood of GERD, with a score between 11-18 suggesting 89% or greater likelihood.

  Week 2

• Measure changes in GERD quality of life using the GERD-HRQL questionnaire

  GERD-HRQL- Gastroesophageal reflux disease (GERD) - Health Related Quality of Life (HRQL) The scale has 15 items, which focus on heartburn symptoms, dysphagia, medication effects and health condition. Each item is scored from 0 to 5 (maximum score 75), with a higher score indicating a better QOL

  Week 2

• Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire

  The esophageal hypervigilance and anxiety scale (EHAS) The EHAS is a 15-item measure with two factors evaluating esophageal hypervigilance and symptom specific anxiety scored on a 0-4 Likert scale. Items are summed to yield a total score ranging from 0 - 60 (Greater hypervigilance/anxiety).

  Week 2

• Measure changes in GI symptom severity using the PAGI-SYM questionnaire

  Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) The PAGI-SYM includes 6 subscales ranging from 0 (none) to 5 (very severe): heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain.

  Week 2

• Measure changes in GI related patient assessment of quality of life using PAGI-QOL

  Patient Assessment of Gastrointestinal Disorders-Quality of Life (PAGI-QOL) The PAGI-QOL Is an instrument scoring 30 factors each from 0 (none of the time) to 5 (all of the time). Symptoms are assessed over a 2 week period and include the 5 domains daily activities, clothing, diet and food habits, psychological well-being/distress, and relationships.

  Week 2

Secondary Outcomes (2)

• Measure changes in anxiety and depression using the HADs scale

  Week 2

• Measure changes in resilience using the brief resilience scale

  Week 2

Study Arms (1)

VR Arm

OTHER

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

Other: Virtual Reality

Interventions

Virtual Reality OTHER

Virtual Reality therapy

VR Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastrointestinal Diseases; Chest Pain

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andree Koop, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 15, 2024
• Study Start: February 14, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)