Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic standards established by the International Association for the Study of Pain (IASP) and having a pain severity level between 3 and 6 (classified as mild to moderate) at the time of enrollment,
- •Diagnosed with ovarian caner
- •Demonstrating clear cognitive and expressive abilities,
- •Being aged 45 or older,
- •Providing voluntary consent after fully understanding the study's objectives.
排除标准
- •Individuals with a history of mental illness or communication disorders,
- •Those experiencing vision or cognitive impairments,
- •Individuals undergoing pain medication treatment during the intervention period.
研究组 & 干预措施
Intervention group
The intervention consist of 26 participants using biofeedback based dynamic-difficulty game for 15 mins each.
干预措施: biofeedback based dynamic-difficulty game (Device)
Control group
Twenty six participants in the control group played a serious game with a fixed difficulty level for 15 mins each
干预措施: fixed difficulty game (Device)
结局指标
主要结局
Pain level
时间窗: 15 mins
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.
次要结局
- Immersion level(15 mins)
- Pain related anxiety(15 mins)
研究者
Jianan Zhao
Principal Investigator
Shanghai Jiao Tong University School of Medicine