Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility of VoiceLove digital therapy use by participants in the ICU
研究概览
简要总结
The study is a single-center, single-arm, prospective trial to evaluate the feasibility, safety, and acceptability of VoiceLOVE digital therapy for the management of delirium in surgical ICU patients. 15 participants will be enrolled. The study expects that 70% of participants will complete 20 -25 minutes of the VoiceLOVE digital therapy. Descriptive statistics will be used to summarize the findings. The intent is that this study will provide information for a larger, subsequent clinical trial of surgical ICU patients who are at risk for delirium.
详细描述
VoiceLove digital therapy includes voice recordings of the participant's loved one delivered at the bedside via a smartphone attached to the bed. The VoiceLove digital therapy will be delivered in the morning and in the evening and will play for 20-25 minutes each session.
Participants will have a pre-operative visit, 3 consecutive intervention visits with vital signs assessment, 7 days of assessments of Confusion Assessment Methods (CAM)-ICU (morning and evening), and 7 days of a Richmond Agitation-Sedation Scale assessment. The participant will provide an assessment of the acceptability of the VoiceLove digital therapy using a system usability scale score at the end of their participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Men and women aged ≥18 years admitted to the hospital after major surgery (elective or non-elective) require a hospital stay of at least five days following surgery, including an ICU stay for at least three days after the surgical procedure
- •At risk of delirium, as per ICU delirium risk score or existing diagnosis
- •Family members or caregivers involved in patient care at least 18 years of age.
- •Clinical team members caring for the patients
排除标准
- •Patients in the ICU who have
- •a history of severe mental illness,
- •admission for a drug overdose,
- •severe vertigo,
- •a history of severe postoperative nausea and vomiting,
- •hearing or visual impairments,
- •preexisting severe dementia (Montreal Cognitive Assessment Score <15),
- •neurological surgeries.
结局指标
主要结局
Feasibility of VoiceLove digital therapy use by participants in the ICU
时间窗: Baseline to day 3
70% of participants complete two 25-minute sessions of VoiceLove digital therapy per day for 3 days
次要结局
- Change in peripheral arterial oxygen saturation (SpO2) after VoiceLove digital therapy(Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.)
- Change in blood pressure after VoiceLove digital therapy(Start of Voice Love digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.)
- Change in respiratory rate after VoiceLove digital therapy(Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.)
- Change in heart rate after VoiceLove digital therapy(Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.)