Habit Awareness Device for Treatment of Onychophagia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean Change in Nail Biting Behavior as Measured by Number of Patient Reported Vibrations a Day
研究概览
简要总结
This clinical trial wants to find out if using a special bracelet that vibrates gently whenever someone with a nail-biting problem bites their nails can help them stop. The investigators are looking at adults who bite their nails a lot. If this bracelet works, it could make nail-biters bite their nails less and have a better life.
The main question the investigators are trying to answer is: "Does the gentle vibration from the bracelet make people bite their nails less?"
The investigators will give participants a bracelet that vibrates when it senses nail-biting for 12 weeks. Participants will need to download an app that connects to the bracelet. This app will help the investigators keep track of how often participants get these vibration signals and see if nail-biting decreases while using the bracelet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with onychophagia
- •Must understand and voluntarily sign an informed consent form
- •Must be aged 18-95 years at the time of consent
- •Must be able to adhere to the study visit schedule and other protocol requirements
排除标准
- •Subject is unable to provide written informed consent for any reason.
- •Subject is sensitive or allergic to any of the elements included in this study.
- •Subject is unable to complete the required pain dairy.
- •Subject is pregnant, planning pregnancy, or nursing.
- •Subject does not have a compatible personal device with either IOS 13.0 or greater or Android version 6.0 or greater.
研究组 & 干预措施
HabitAware Participants
Patients will be asked to wear the HabitAwareness bracelet for 12 weeks. The bracelet provides the attention stimulus of gentle vibration when the motion of nail biting is sensed.
干预措施: HabitAware group (Device)
结局指标
主要结局
Mean Change in Nail Biting Behavior as Measured by Number of Patient Reported Vibrations a Day
时间窗: baseline; 4 weeks; 8 weeks; 12 weeks
次要结局
- Change in nail length in millimeters(Monthly for 3 months)
- Change in nail health as measured by Malone-Massler Scale For Nail Biting(baseline; 3 months)