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NCT Number: NCT06262126

Virtual Reality for Non-cardiac Chest Pain

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Wendi Lehman

CONTACT

[email protected]

904-953-8742

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

Virtual Reality therapy

Primary outcomes

  1. Measure changes in GERD symptoms using the GERDQ questionnare

    Time frame: 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.

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

    Time frame: 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

  3. Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire

    Time frame: 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).

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Measure changes in anxiety and depression using the HADs scale

    Time frame: 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'.

  2. Measure changes in resilience using the brief resilience scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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