Virtual Reality for Non-cardiac Chest Pain

Not Applicable

Recruiting

• Conditions: Gastrointestinal Diseases; Chest Pain
• Interventions: Other: Virtual Reality

• Registration Number: NCT06262126
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-08
• Study Start: 2024-02-14
• Study First Posted: 2024-02-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VR Arm	Virtual Reality	Viritual Reality therapy arm. All patients will receive virtual reality therapy.

Primary Outcome Measures

Name	Time	Method
Measure changes in GERD symptoms using the GERDQ questionnare	Week 2	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.
Measure changes in GERD quality of life using the GERD-HRQL questionnaire	Week 2	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
Measure changes in GI symptom severity using the PAGI-SYM questionnaire	Week 2	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.
Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire	Week 2	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).
Measure changes in GI related patient assessment of quality of life using PAGI-QOL	Week 2	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.

Secondary Outcome Measures

Name	Time	Method
Measure changes in resilience using the brief resilience scale	Week 2	The brief resilience scale is a 6 question survey assessing resiliency with questions assessed by a 5 point Likert scale.; 12-item short form survey (SF-12). The SF-12 is a 12 question survey assessing the impact of health on a patient's everyday life. The questions assess 8 domains including physical activities, social activities, pain, mental health, vitality, general health perceptions and limitations related to physical and emotional problems.
Measure changes in anxiety and depression using the HADs scale	Week 2	The Hospital Anxiety and Depression Scale (HADs) consists of 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States