Effects of a Self-Regulation-Based E-MOTE Emotional Care Program Delivered Via an AI-Assisted Robot and Supported by Mobile Platforms for Newly Diagnosed Gynecologic Cancer Patients From Surgery to 6-Month Post-Discharge
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Distress
研究概览
简要总结
To evaluate the effectiveness of the E-MOTE Emotional Care Program, delivered through the Kebbi robot and the LINE Official Account, for patients newly diagnosed with gynecologic cancer undergoing surgery. The primary outcomes are psychological distress , and the secondary outcomes are physical symptoms, stress index, and quality of life.
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
- 是
入选标准
- •***Patients***
- •Inclusion Criteria:
- •Aged 18 years or older.
- •Diagnosed with gynecologic cancer and undergoing surgery.
- •Willing to receive E-MOTE robot and wear a smart wearable device.
- •Willing to complete pre-test and post-test questionnaires.
排除标准
- •Unable to communicate clearly.
- •Unwilling or unable to participate in the study in its entirety.
- •***Nurse***
- •Inclusion Criteria:
- •Aged 18 years or older.
- •As a clinical nurse and has cared for patients who received the E-MOTE robot
- •Exclusion Criteria:
- •- Unwilling to participate in the qualitative interview.
结局指标
主要结局
Distress
时间窗: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Investigators utilized the Distress Thermometer(DT) as the primary outcome measure. The scale uses a 11 Liker scale, where 0 indicates no distress at all and 10 represents the most severe distress.Higher score indicates a more severe distress. When the score is 4 or higher, a Problem List (PL) is used to further identify factors contributing to the emotional distress.
Depression
时间窗: Measurements will be taken before the intervention, three days after surgery, and one week after discharge
Investigators utilized the Patient Health Questionnaire (PHQ-9) as the primary outcome measure to assess depression. The scale consists of 9 items, each rated on a 4-point Likert scale (0 = not at all, 3 = nearly every day). The total score ranges from 0 to 27, and depression severity can be categorized as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20 or above).Higher score indicates a more severe depression.
次要结局
- Quality of Life Measurement(Measurements will be taken before the intervention, three days after surgery, and one week after discharge)
- Symptom Severity(Measurements will be taken before the intervention, three days after surgery, and one week after discharge)
- Stress Index(Measurements will be taken before the intervention, three days after surgery, and one week after discharge)