Virtual Reality for Non-cardiac Chest Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Diseases, Chest Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain
Overview
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.
Interventions
- Other Virtual Reality
Virtual Reality therapy
Primary outcome measures
- Measure changes in GERD symptoms using the GERDQ questionnare [Time frame: Week 2]
- Measure changes in GERD quality of life using the GERD-HRQL questionnaire [Time frame: Week 2]
- Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire [Time frame: Week 2]
- Measure changes in GI symptom severity using the PAGI-SYM questionnaire [Time frame: Week 2]
- Measure changes in GI related patient assessment of quality of life using PAGI-QOL [Time frame: Week 2]
Secondary outcome measures (2)
- Measure changes in anxiety and depression using the HADs scale [Time frame: Week 2]
- Measure changes in resilience using the brief resilience scale [Time frame: Week 2]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic Florida — Jacksonville
Identifiers
NCT: NCT06262126 · 23-012673