Virtual Reality for Non-cardiac Chest Pain

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262126
• Other study ID #: 23-012673
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Other:
• Virtual Reality
Virtual Reality therapy

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Measure changes in anxiety and depression using the HADs scale	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'.	Week 2
Secondary	Measure changes in resilience using the brief resilience scale	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.	Week 2