Data Sheet 1_The impact of an immersive digital therapeutic tool on experimental pain: a pilot randomized within-subject experiment with an active control condition.docx

Background

Pain is a complex and multifaced sensory and emotional experience. Virtual reality (VR) has shown promise in reducing experimental pain and chronic pain. This study examines an immersive VR environment initially designed for endometriosis patients, which demonstrated short-term analgesic effects. The research aims to determine the impact of the VR environment on experimental pain intensity and unpleasantness both during and after VR exposure (3D with binaural beats), while using an active control condition (2D with no binaural beats). Additionally, a secondary objective of the study was to identify the psychological and psychophysical factors that predict the analgesic effects of the immersive digital therapeutic tool.

Methods

The study involved twenty-one healthy individuals and used a within-subject design, comparing a VR treatment with an active control condition. Continuous heat stimulation was applied to the left forearm with a Peltier thermode. Pain ratings were collected for immediate and short-term effects.

Results

In both the VR and Control conditions, there were no significant differences in pain intensity before, during, and after exposure. However, during VR exposure, there was a significant decrease in pain unpleasantness as compared to before exposure (p < 0.001), with a 27.2% pain reduction. In the Control condition, there were no significant differences in pain unpleasantness during and after exposure. Furthermore, no psychological and psychophysical factors predicted the analgesic effects.

Discussion

The study investigated how a VR environment affected experimentally induced pain in healthy volunteers. It showed that VR reduced pain unpleasantness during exposure but had no lasting impact. The VR environment mainly influenced the emotional aspect of pain, possibly due to its inclusion of binaural beats and natural stimuli. The study suggests that the VR environment should be tested in chronic pain population with high distress levels.

Registration number (clinicaltrials.gov)

NCT06130267.