The purpose of this study is to determine if virtual reality therapy is safe and tolerable in treating gastroparesis.
After informed consent patients will be randomized to a 4 week treatment program comparing active VR treatment to sham VR treatment. Symptoms will be measured at baseline and at 2 and 4 weeks using validated questionnaires. A short questionnaire will be answered daily to evaluate changes in nausea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Virtual reality programs consisting of interactive games, meditation and deep breathing exercises, and passive virtual reality experiences designed to facilitate relaxation.
Virtual reality program with two-dimensional nature video
Mayo Clinic in Florida
Jacsonville, Florida, United States
Patient-reported adverse events
Number of patient-reported adverse events assessed using standardized daily patient-reported adverse event questionnaires
Time frame: 4 weeks
Changes in global gastroparesis symptom scores
Measured by the self-reported GCSI (Gastroparesis Cardinal Symptom Index-daily diary); consisting of questions about severity of symptoms experienced during the past 24 hours on a scale of none, mild, moderate, severe, and very severe.
Time frame: Baseline, 4 weeks
Changes in gastrointestinal disorder symptoms
Measured using the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire; consisting of questions about severity of symptoms related to gastrointestinal problem during the past 2 weeks on a scale of 0=note to 5=very severe.
Time frame: Baseline, 4 weeks
Changes in individual scores for nausea
Measured using Visual Analogue Scale (VAS) where subject place a X on a scale to show how much nausea they had today; scale is 0%=no nausea, 100%=worse nausea ever.
Time frame: Baseline, 4 weeks
Changes in abdominal pain
Measured using a Numeric Pain Rating Scale (NRS) where subject place a X on a scale to show how much abdominal pain they had today; scale is 0% no abdominal pain, 100% worse abdominal pain ever.
Time frame: Baseline, 4 weeks
Changes in bloating
Measured using the validated Mayo Bloating Questionnaire to assess subject symptoms of gastroparesis
Time frame: Baseline, 4 weeks
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Change in work productivity
Measured using the validated WPAI (work productivity activity index) to assess subject ability to work and perform regular activities
Time frame: Baseline, 4 weeks
Change in Quality of life
Measured using the self-reported Short-Form 12 questionnaire; health survey to assess subject views about their health
Time frame: Baseline, 4 weeks