Humanistic Continuing Care Via WeChat for Patients Undergoing Thermal Ablation of Papillary Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in emotion distress from baseline to post-procedure (HADS)
研究概览
简要总结
The goal of this clinical trial is to test whether human-centered nursing care lowers emotional distress and improves quality of life for people who are awake during thyroid thermal ablation. The procedure uses local anesthesia, so participants remain awake and may feel tense. Human-centered care focuses on emotional support, clear communication, comfort, and follow-up, and it may improve the experience and recovery for patients.
The main questions are:
Does human-centered nursing care reduce emotional distress levels in patients undergoing thyroid thermal ablation?
Does human-centered nursing care improve patient quality of life after thyroid thermal ablation?
If there is a comparison group: Researchers will compare human-centered nursing care to usual nursing care to see if human-centered care leads to lower emotional distress and higher quality of life.
Participants will:
Receive either human-centered nursing care or usual nursing care.
Complete questionnaires before, during, and after the procedure to measure emotional distress, quality of life, pain, and satisfaction with care.
Have their vital signs and quality of life tracked during and after the procedure.
Have their adherence to care plans and any complications monitored.
The main outcomes are emotional distress levels and quality of life. Other outcomes include pain and vital signs during the procedure, satisfaction with care, and complication rates. Results may guide better care for people undergoing small, minimally invasive treatments while awake.
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)
盲法说明
Personnel responsible for evaluating the primary or secondary outcome measures remain unaware of the participants' group assignments.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-60 years; scheduled for thyroid thermal ablation
- •Papillary thyroid carcinoma (PTC)
- •Number of target lesions <= 3
- •Largest lesion diameter <= 2 cm; clinical stage T1N0M0 by imaging
- •Awake and able to cooperate under local anesthesia
- •Owns a smartphone and can use WeChat
排除标准
- •Serious medical comorbidities or cognitive impairment that precludes participation
- •Prior thyroid surgery or thermal ablation
- •Unwilling or unable to join the WeChat group or complete postoperative follow-up
研究组 & 干预措施
Usual Care (No Structured WeChat Program)
干预措施: Usual Care (No Structured WeChat Program) (Procedure)
Humanistic Continuing Care via WeChat
干预措施: Humanistic Continuing Care via WeChat (Behavioral)
结局指标
主要结局
Change in emotion distress from baseline to post-procedure (HADS)
时间窗: From enrollment to the end of treatment at 3 months
Change in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scores from baseline to 3 months
时间窗: From enrollment to the end of treatment at 3 months
Change in Thyroid Cancer-Specific Quality of Life Questionnaire scores from baseline to 3 months
时间窗: From enrollment to 3 months after end of treatment
次要结局
- Intraoperative pain intensity (Visual Analog Scale)(Intraoperative period (during the procedure))
- Patient satisfaction with nursing care (Newcastle Satisfaction with Nursing Scale, NSNS)(Postoperative Day 1)
研究者
Ming-an Yu
Head of department of intervention medicine
China-Japan Friendship Hospital