Virtual Reality for Non-cardiac Chest Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Virtual Reality
Other interventionVirtual Reality therapy
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: VR ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 22
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
Time frame
Week 23
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).
Time frame
Week 24
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.
Time frame
Week 2Secondary outcomes
1
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'.
Time frame
Week 22
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.
Time frame
Week 2Sponsors and contacts
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Source ClinicalTrials.gov