S514 Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Controlled, Double-Blind Pilot Study

Abstract

Introduction: Functional dyspepsia (FD) is a common functional GI disorder, characterized by symptoms of abdominal pain, nausea, and/or early satiety. Virtual reality (VR) is a promising intervention which has been shown to alleviate pain in various clinical settings. There are currently no studies assessing VR for the treatment of FD. The aim of this study was to investigate the effectiveness and safety of VR for the treatment of FD. Methods: This is a prospective, single-center, randomized, controlled, double-blinded study of adult patients with FD (Rome IV criteria). Enrolled patients were randomized 2:1 (experimental to control). Experimental patients were given a VR headset with software consisting of immersive audiovisual programs. Control patients were given an identical headset with 2-D nature videos. Patients were asked to use their headset at least daily and completed Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) and Nepean Dyspepsia Index (NDI) questionnaires at their initial visit, after 1 week of use, and at the conclusion of the 2-week study. Paired sample t-tests were used to compare questionnaire scores. Results: Thirty-seven patients were enrolled in the study (27 experimental, 10 controls); demographic data are shown in Table (Table). Patients used the VR headset an average of 1.3 times/day for a mean of 23.2 minutes/day. Total PAGI-SYM scores significantly decreased for all patients [2.51 (baseline) to 0.62 (week 2); p=0.000]. Notably, patients in the experimental group had greater improvement in mean total PAGI-SYM scores [2.51 baseline) to 1.83 (week 2); mean difference -0.68; p=0.000], compared to the control group [2.50 (baseline) to 2.04 (week 2); mean difference -0.46; p=0.046]. Further, quality of life (QoL) significantly improved for all patients, as the total NDI QoL score increased from 40.97 (baseline) to 57.14 (week 2), p=0.000, though experimental patients saw greater improvement in QoL, compared to control patients (Figure). Seventeen patients (45.9%; 11 experimental, 6 controls) reported non-serious adverse effects (AE), with headache and dizziness being the most common; 1 experimental patient withdrew due to AEs (migraines). Conclusion: In the first randomized, controlled, double-blind study to assess VR for the treatment of FD, VR was shown to be safe and result in statistically significant overall improvement in symptoms and QoL in FD patients. We propose VR as a novel treatment for FD worthy of further investigation.Figure 1.: Total PAGI-SYM and NDI Quality of Life Scores Table 1. - Study Population Demographic Data Mean Age 45 years (± 14) Mean BMI 24.56 (± 6.79) SexFemaleMale 30 (81.1%)7 FD subtypeEPSPDSMixed EPS/PDS 12 (32.4%)20 (54.1%)5 (13.5%) Anxiety 17 (45.9%) Depression 9 (24.3%) PTSD 2 (5.4%) Fibromyalgia 4 (10.8%) Prior H. pylori infection 5 (13.5%) MedicationsPPIAntidepressantsGabapentinOpioidsNSAIDs 16 (43.2%)11 (29.7%)4 (10.8%)2 (5.4%)0 Alcohol Use 7 (18.9%) Marijuana Use 4 (10.8%)