Pain and Stress Detection and Relief in People With Dementia Using Portable EEG Headband: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Changes on pain level
研究概览
简要总结
The objective of this study is to investigate the feasibility and efficacy of using the portable EEG headband and the headband-guided meditation practices for pain and stress relief in people with dementia in Hong Kong. Additionally, it explores the potential use of the headband as a biomarker for pain and stress in this target group.
详细描述
This project is a Phase II clinical trial to access the feasibility and efficacy of incorporating portable EEG headband-guided meditation for alleviating pain and stress among people with early and moderate dementia in Hong Kong. Sixty dementia people will be recruited. Participants in the intervention group will wear the EEG headband and engage in 10-minute guided meditation sessions, while the control group will wear the EEG headband and undergo a 10-minute resting session. Efficacy will be evaluated using the Wong-Baker Faces Pain Rating Scale, Perceived Stress Scale, and EEG signals associated with pain and stress. Immediate post-assessment focus group interviews will be conducted to explore caregiver's experiences with the use of portable EEG headbands in this study.
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 (Participant)
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
- •People with mild to moderate severe dementia;
- •Have chronic pain or have experienced stress for at least six months;
- •Be able to communicate and express pain;
- •Have no prior experience with any type of meditation training;
- •Volunteer to participate in the study and provide written informed consent
排除标准
- •Person with other acute or terminal illnesses that may not be able to stay in a home living environment frequently;
- •With severe visual or hearing problems that would hinder communication;
- •With infectious diseases that could be transmitted by using the headband.
结局指标
主要结局
Changes on pain level
时间窗: Pre-intervention, immediately post-intervention
Pain detection will be measured by the Wong-Baker Faces Pain Rating Scale. The scale show a series of facial expressions, ranging from a happy face at "0", or "no hurt", to a crying face at 10, indicating "hurts like the worst pain imaginable".
次要结局
- Changes on stress level(Pre-intervention, immediately post-intervention)