Farm Design Blog Best Practices for Identifying and Managing Participant Distress

Human factors engineers conduct usability testing sessions to inform medical device manufacturers on whether a device is safe and effective before commercialization. Such testing sessions often include both healthcare professionals and patients. To ensure that the results gathered in a usability study will reflect actual use case scenarios, usability studies are conducted in simulated-use environments that closely represent the real-world use environments of the device being investigated, as specified in the FDA Guidance. By immersing participants in a realistic, simulated-use environment, we gain valuable insights on how to mitigate use-related issues through improvement to the device design. However, we must pay close attention to participants who might become distressed during a usability study due to past trauma that may resurface. As human factors engineers, we can learn best practices for identifying and managing participant distress that might be triggered by simulated use environments. How is trauma learned? We know from Watson’s classic Little Albert Study (1920) that fear, or trauma, can be learned through associations between fear stimuli and previously neutral stimuli. People may experience a traumatic event while simultaneously being exposed to a variety of auditory, visual, olfactory, and tactile cues that are present in an environment. These seemingly neutral background cues can become associated with a traumatic event, in that a person may recall the traumatic event when later sensing the background cues on their own. For example, if a person previously received painful treatments (unconditioned stimuli) while being exposed to the sound of a heart monitoring alarm (neutral stimulus), it’s possible that they might recall the negative experience when hearing auditory cues from a heart monitoring alarm at a later time (e.g., during a usability study).