Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Patients with Ovarian Cancer: A Randomized Controlled Trial.

Background: Persistent pain affects many middle-aged and older patients with ovarian cancer. Serious games offer non-pharmacological relief, but their effectiveness and immersion monitoring in this population remain underexplored. Objective: To evaluate the efficacy of a biofeedback-driven serious game with dynamic difficulty in reducing pain and enhancing immersion. Methods: A two-arm, single-blinded randomized controlled trial was conducted with 52 participants randomized into an intervention group (biofeedback-driven dynamic-difficulty game) or a control group (fixed-difficulty game). Both groups engaged in a 15-minute gameplay session. The primary outcome was pain intensity, where the secondary outcomes were pain-related anxiety, immersion level, and user experience. Results: Both groups showed significant reductions in pain intensity and pain-related anxiety from baseline (p < 0.05). No significant between-group differences were observed in these outcomes. The intervention group, however, exhibited a significantly higher average immersion level compared to the control group (p < 0.01; d = 1.08; β = 0.11 [-0.38, 0.60]) . Participants in the intervention group also rated the game as more innovative, interesting, supportive, efficient, and exciting, though slightly more difficult to use. Conclusion: The biofeedback-based serious game effectively enhances immersion and may support pain and anxiety reduction in older ovarian cancer patients.