Consistent pain affects most middle-aged and older ovarian cancer patients. Non-pharmacological pain interventions, such as serious games, offer a promising approach to alleviating this pain by providing an effective sense of immersion. However, current games on the pain alleviation lack examination of its efficacy in middle-aged and older population and real-time monitoring of immersion level, particular since immersion level is highly associated with pain alleviation effect and adjustable to challenging level of game difficulty. This study developed a serious game with biofeedback-driven dynamic difficulty. Then examined its feasibility and efficacy through a two-arm, single-blinded randomized controlled trial. A total of 52 participants were recruited and randomized into intervention group and control group to receive biofeedback-based dynamic-difficulty serious game or fix-difficulty serious game for 15 mins each, respectively. The primary outcome was the assessment of the pain level, measured using the Visual Analog Scale. The secondary outcomes included pain-related anxiety, immersion level, and user experience.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
A biofeedback based dynamic-difficulty serious game rooted in distraction therapy.
A fixed difficulty serious game rooted in distraction therapy.
Jianan Zhao
Shanghai, Shanghai Municipality, China
Pain level
Patients' pain perception was assessed using the Visual Analog Scale (VAS), a widely accepted tool in clinical settings due to its convenience and ease of understanding. The VAS employs a 10-scale ruler from 1 to 10 with a movable marker, where higher number indicating a more severe level of pain. Patients are instructed to place the marker on the ruler at the point that corresponds to their current level of pain.
Time frame: 15 mins
Pain related anxiety
The Psychological Assessment of the Symptoms of Pain (PASS) scale was used to evaluate patients' psychological states during painful episodes. This scale consists of four subscales - cognition, avoidance, fear, and physiological anxiety - each containing five items, totaling 20 items. Responses are rated on a 5-point Likert scale from 0 to 4, with higher scores indicating greater levels of pain-related anxiety and fear. The PASS scale demonstrates good reliability and validity, providing a scientific means of assessing pain-related psychological distress.
Time frame: 15 mins
Immersion level
Immersion level was assessed using a combination of objective and subjective measures. Physiological data on immersion level indicators were obtained through the wearable EEG device using the TGAM brainwave monitoring module, while subjective evaluation was conducted using the Attention Control Scale (ACS). The ACS comprises two subscales: Attention Focus and Attention Shift. This study utilized the Attention Shift subscale to measure improvements in patients' ability to shift attention after intervention. Each item on the Attention Shift subscale was rated on a Likert scale ranging from 1 to 4, with higher scores denoting more frequent occurrences, thus shedding light on patients' attentional control capabilities and their aptitude to redirect focus.
Time frame: 15 mins
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