We hypothesize that patients with gastroparesis (GP) who use regular sessions of active virtual reality (VR) will experience a greater reduction in global symptoms of gastroparesis, as measured by a reduction in symptom scores using the Gastroparesis Cardinal Symptom Index (GCSI), the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM), a visual analog scale for nausea (VAS) and a numerical rating scale for abdominal pain (NRS), compared to patients with GP treated with sham VR therapy. This pragmatic trial is a pilot study to assess the safety, tolerability and efficacy of virtual reality for the treatment of gastroparesis.
There are three main aims for this study. One, to determine whether VR is safe for the treatment of GP. Two, to determine whether using VR therapy is tolerable for the treatment of GP symptoms. Three, to determine whether VR is an effective treatment for symptoms of GP compared to sham VR therapy. A key objective of the third aim will be to compare changes in global gastroparesis symptom scores, as measured by the GCSI, at the end of the 4-week study period compared to baseline, in patients with GP treated with active VR therapy compared to those treated with sham VR. Secondary objectives for the third aim will be to assess changes in overall total PAGI-SYM scores, changes in individual scores for nausea (using a VAS), changes in abdominal pain using a NRS, and changes in bloating using the validated Mayo Bloating Questionnaire. Changes in work productivity will be assessed during the 4-week trial using the validated WPAI (work productivity activity index) while short-term changes in quality of life will be assessed using the Short-Form 12 questionnaire.