A Prospective Study of the Effectiveness of Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- ICU-acquired anxiety
研究概览
简要总结
The goal of this clinical trial is to learn the effect of Speech-to-speech Voice-Cloning Care (SVCC) on improving ICU-acquired anxiety for critically ill patients. The main question it aims to answer is:
- Can the use of participants' loved ones' voices by nurses in communication while providing care lead to better mental health and clinical outcomes?
Researchers will see if the implementation of SVCC can reduce anxiety and depression and improve clinical outcomes.
Participants will:
- Receive the SVCC intervention until the endotracheal tube (ETT) is removed.
- Keep a diary of delirium, the duration of mechanical ventilation, and ICU stays.
详细描述
During the SVCC, healthcare will be delivered by nurses who will communicate with participants using the familiar voices of their loved ones, transformed in real-time by an artificial intelligence voice-cloning tool.
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
- None
盲法说明
The independent statistician conducting the interim analysis will be masking. The statistician analyzing the primary and secondary outcome data will also be masking.
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
- •Expected mechanical ventilation time > 24 hours;
- •Expected ICU stay > 72 hours;
- •Language: Chinese;
- •Richmond Agitation-Sedation Scale (RAAS) score ≥ -2 points;
- •Hemodynamic stability.
排除标准
- •Severe hearing impairment or worse (Grade 3 or higher according to WHO's Grades of hearing impairment);
- •Disorders of consciousness or comprehension;
- •Mental or psychological disorders that are being treated with medication;
- •Head trauma or surgery resulting in an inability to wear earphones.
结局指标
主要结局
ICU-acquired anxiety
时间窗: Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge.
The primary outcome assessment will be conducted using the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS is used to assess symptoms of anxiety and depression in medical patients, which includes two subscales: one for anxiety (HADS-A) and one for depression (HADS-D). Each subscale consists of seven items, with scores for each item ranging from 1 to 4. The total score for each subscale ranges from 7 to 28, with a score of 11 or above considered to be the critical value.
次要结局
- ICU-acquired depression(Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge.)
- Incidence of Delirium(Twice daily from Day 1 through ICU discharge, an average of 7 days.)
- Duration of Mechanical Ventilation(From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.)
- ICU Stay(From ICU admission through ICU discharge, an average of 7 days.)
- Qualitative assessment(Once during the follow-up visit, three days after the participant is discharged from the ICU.)