Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale (HADS) - Anxiety
研究概览
简要总结
The purpose of this study is to assess the use of an audio recording containing positive suggestion as a means to provide needed psychological support to critically ill patients in a feasible and reliable manner.
详细描述
Following screening and consenting processes, patients will be randomized to enroll in interventional or control groups. The interventional group will listen to an audio recording of psychological support based on positive suggestion for about 30 min each day via headphones. At the time of ICU discharge, patients will be administered validated questionnaires to screen for symptoms of anxiety/depression (HADS), PTSD (IES-r), cognitive dysfunction (MOCA-blind), as well as evaluation of health status (EQ-5D). Six months post ICU discharge, patients will again be contacted and repeat the assessment with above questionnaires. Scores on the questionnaires will be compared between the groups at the two times points. Patient demographic data will also be obtained and assessed to contextualize study findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Acute respiratory failure and/or requiring vasopressors
- •Admitted to the ICU
- •Expected to stay >48 hours in the ICU
排除标准
- •History of dementia
- •History of mental retardation
- •History of suicide attempt
- •History of psychotic disorders such as schizophrenia
- •Acute alcohol/substance intoxication or withdrawal
- •Severe metabolic encephalopathy
- •Patients on comfort care
- •Patients not expected to survive the hospital stay
- •Those with hearing impairment
- •Non-English speaking.
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS) - Anxiety
时间窗: within 96 hours of ICU discharge
A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; \> 11: Abnormal. Total questions: 14 Anxiety 7 Depression 7 A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; \> 11: Abnormal. TL questions: 14: Anxiety 7, Depression 7
次要结局
- Impact of Events Scale-Revised(6 months following ICU discharge)
- Hospital Anxiety and Depression Scale (HADS) - Depression(6 months following ICU discharge)
- Montreal Cognitive Assessment-Blind (MoCA-blind)(6 months following ICU discharge)
- Hospital Anxiety and Depression Scale (HADS) - Anxiety(6 months following ICU discharge)
- EQ-5D(6 months following ICU discharge)
研究者
Lioudmila Karnatovskaia
Principal Investigator
Mayo Clinic