Effect of the PainCoach App on Pain and Opiate Use in the First Two Weeks After Total Knee Replacement: Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Change in opiate use in the first two weeks at home after TKR
研究概览
简要总结
Less is known about pain and opiate use at home directly after total knee replacement (TKR). Regarding side effects, low opiate use is desired. An e-health application, PainCoach app, was developed to guide patients in pain control and opiate use.
The aim of this study was to investigate the effect of the PainCoach app on pain and opiate use in TKR patients in the first two weeks at home after surgery. The hypothesis was that the use of this app would decrease pain and opiate use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned for primary TKR
排除标准
- •No possession of a smartphone or tablet
- •Contra-indication to any of the pain medication used in the study
- •No email address
- •No internet at home
- •No thorough command of the Dutch language
- •Suffering from memory disorders
- •Surgery under general anaesthesia
研究组 & 干预措施
PainCoach-app group
In the PainCoach-app group, in addition to receiving the aforementioned usual care, the PainCoach app was downloaded on each patient's smartphone or tablet. Patients could use this app whenever they wanted until day 14 after surgery. They were not subjected to any different treatment compared to the control group, i.e. advice on pain management was delivered in an extra and different way, but the pain medication itself was exactly the same for both groups.
干预措施: PainCoach app (Behavioral)
Control group
The control group received usual care.
结局指标
主要结局
Change in opiate use in the first two weeks at home after TKR
时间窗: 14 measurement points: daily from day 1 to 14 after surgery
Oxycodon (5 mg per tablet) use was recorded in quantities per 24 hours
Change in pain during activity in the first two weeks at home after TKR
时间窗: 14 measurement points: daily from day 1 to 14 after surgery
Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
Change in pain at rest in the first two weeks at home after TKR
时间窗: 14 measurement points: daily from day 1 to 14 after surgery
Pain at rest was daily measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
Change in pain at night in the first two weeks at home after TKR
时间窗: 14 measurement points: daily from day 1 to 14 after surgery
Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
次要结局
- Change in pain acceptance at rest, during activity and at night in the first two weeks at home after TKR(14 measurement points: daily from day 1 to 14, and at 1 month after surgery)
- Pain at rest(1 month after surgery)
- Change in other pain medication use in the first two weeks at home after TKR(14 measurement points: daily from day 1 to 14 after surgery)
- Change in experiences with the executed recommended physiotherapy exercises in the first two weeks at home after TKR(14 measurement points: daily from day 1 to 14 after surgery)
- Function(1 month after surgery)
- Pain during activity(1 month after surgery)
- PainCoach app's perceived effectiveness(Day 14 after surgery)
- Pain at night(1 month after surgery)
- Function and pain(1 month after surgery)
- Quality of life(1 month after surgery)
- Active PainCoach app use(From day 1 to 14 after surgery)