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A virtual reality headset using software consisting of passive and active immersive 3D audiovisual programs improved symptoms and quality of life for patients with functional dyspepsia, a randomized pilot study showed.

Compared with a control group who watched 2D nature videos on a virtual reality headset, those in the experimental group experienced greater reductions in their total Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) scores from baseline to 2 weeks (2.50 to 2.04 with the 2D videos [P<0.05] vs 2.51 to 1.83 with the virtual reality headset [P<0.001]), reported David Cangemi, MD, of the Mayo Clinic in Jacksonville, Florida.

The experimental patients also had significant improvements in nearly all subscales of the PAGI-SYM, including for lower abdominal pain, early satiety, nausea/vomiting, heartburn, upper abdominal pain, and bloating, while control patients only experienced significant improvements in nausea/vomiting, early satiety, and heartburn, Cangemi noted in a presentation during the American College of Gastroenterology annual meeting.

Although all patients showed improvement in quality of life from baseline to 2 weeks, those in the experimental group experienced greater improvement, with higher Nepean Dyspepsia Index (NDI) scores (42 to 60.05) versus the control group (38.19 vs 49.28).

"We think that virtual reality is an intriguing novel treatment option for functional dyspepsia," Cangemi said. "Clearly, larger trials of longer durations are needed to explore the true benefits of virtual reality, and we intend to be a part of that moving forward."

Scott Gabbard, MD, of the Cleveland Clinic in Ohio, who was not involved in this study, told 番茄社区app that "virtual reality may help to address a significant need in gastroenterology, as there are currently no FDA-approved therapies for functional dyspepsia."

Functional dyspepsia is a common gut-brain interaction disorder and can cause nausea, early satiety, and abdominal pain, among other symptoms. Virtual reality has been shown to be a promising intervention that alleviates pain in many clinical settings, but no studies have assessed its use for functional dyspepsia.

Cangemi noted that virtual reality is "now recognized by the FDA and regulated by the FDA as a novel form of therapy called 'mixed extended reality,'" which is the subject of . Virtual reality devices have been approved for other indications, including for chronic lower back pain when incorporated with cognitive behavioral therapy, as well as for pediatric amblyopia, or lazy eye.

"Virtual reality affects pain perception by attention, concentration, and emotion alteration," the authors noted in their presentation. "Immersive environments diminish pain experience by downregulating noxious stimuli and upregulating noxious stimuli and upregulating non-painful neural signaling."

"Really it's the unique, distractive, and immersive element that virtual reality provides the user, which we think recalibrates the perception of pain in a very powerful manner," Cangemi said.

For their double-blind study, Cangemi and colleagues randomized 37 adults with functional dyspepsia 2:1 to the experimental treatment or control. All patients were asked to use their headset at least once daily for 2 weeks.

"We gave them the freedom to use it as much as they'd like. We also gave them the freedom to select whichever program fit them, so they could choose between passive, active, or guided relaxation programming on the headset," Cangemi explained.

Participants completed validated questionnaires at baseline, in addition to after 1 and 2 weeks of use.

On average, participants used their virtual reality headset 1.3 times per day (mean 23.2 minutes per day).

Among both groups, mean age was 45, and 79.5% were women. Of the functional dyspepsia subtypes, 56.4% had post-prandial distress syndrome, 30.8% had epigastric pain syndrome, and 12.8% had an undefined subtype. About 44% had anxiety, and 23% had depression. As for common medications used, about 44% were on proton pump inhibitors, and 31% were on antidepressants.

Non-serious adverse events occurred among 17 participants, including 11 in the experimental group. The most common adverse events were headache and dizziness. One experimental patient withdrew from the study due to migraines.

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