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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 52
• From 1 Aug 2023 to the primary completion date, 1 Sept 2023
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 45 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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