Hypnosis to Improve Well-beings of Critically Ill Patients and Prevent Post-intensive Care Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Wellbeing at day 28 post intensive care unit discharge
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of a hypnosis intervention in improving well-being at day 28 of an ICU stay. The main question it aims to answer is :
-Does Hypnosis intervention at ICU discharge and on day 7 and 14 on the wards if the patient remains in the hospital, improve wellbeing at 28 days ?
Researchers will compare discharged ICU patients who received standard post-discharge care to discharged ICU patients who received standard post-discharge care and hypnosis intervention on discharge and 7 and 14days after if they are still in the hospital, to see if hypnosis can improve their wellbeing.
Participants will receive a hypnosis session on the day of ICU discharge, a second session seven days post-discharge and a third session at day 14 if they are still in the hospital.
详细描述
Critically ill patients in the Intensive Care Unit (ICU) face numerous challenges both acutely and in the long term. These patients frequently experience acute pain and anxiety due to intubation and induced comas. Following their ICU discharge, they commonly report decreased well-being and quality of life. Additionally, up to 40% of critically ill patients develop post-intensive care syndrome (PICS), which includes mental, physical, and cognitive sequelae that can persist up to one year after discharge. Heavy sedation and medications necessary to manage pain and anxiety are known risk factors for PICS.
The current standard of care in the ICU includes mobilization and nutrition, pain control, and family engagement and empowerment. Furthermore, no other specific interventions are aimed at improving long-term outcomes and preventing PICS.
Several studies have explored using hypnosis to improve the acute care of ICU patients. For instance, a pain protocol that included hypnosis in burn patients hospitalized in the CHUV (Centre Hospitalier Universitaire Vaudois) resulted in reduced pain intensity, reduced opioid use, reduced anxiety, and better wound outcomes, all while lowering costs. A pilot study involving non-invasive ventilation patients showed that hypnosis could improve comfort, mask tolerance, and anxiety levels. Additionally, studies on relaxation therapy have indicated that electronic relaxation therapy is a promising, safe, and effective non-pharmacological solution to enhance overall comfort in alert and non-delirious ICU patients.
However, despite these efforts, there is a lack of efficient interventions specifically targeting the wellbeing of patients after an ICU stay and the prevention of PICS. Existing interventions, such as follow-up programs, rehabilitation, and psychological follow-up, have shown conflicting results. To date, no studies have specifically assessed the effect of hypnosis on the short and longer-term well-being of critically ill patients leaving the ICU and its possible effect on the prevention of PICS.
The investigators hypothesize that providing a hypnosis session at ICU discharge and followed by subsequent sessions on days 7 and 14 on the ward will improve well-being in the short term and reduce PICS symptoms at 3-months. The primary outcome will be the assessment of well-being at day 28 post-ICU discharge. Secondary outcomes will be anxiety, depression, PTSD, and quality of life at three months.
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
- 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
- 否
入选标准
- •On Mechanical Ventilation for at least 2 days
- •Able to give informed consent as documented by signature
- •French speaking
排除标准
- •Refusal of the patient
- •Patient transferred from another ICU
- •Patient is planned for a withdrawal of care or is actively dying
- •Glasgow coma scale (GCS) <15 on ICU discharge
- •Patient presenting with delirium (detected by CAM-ICU) on ICU discharge
- •Patient hospitalized for traumatic brain injury
- •Patient is in jail
- •Patient hospitalized for more than 28 days in the ICU
研究组 & 干预措施
Hypnosis group
Participants in the intervention group will receive a hypnosis session on the day of discharge, a second session seven days post-discharge, and a third session on day 14 if they are still in the hospital. Trained professionals will conduct the hypnosis sessions following a standardized protocol, designed by the study team for critically ill patients.
干预措施: Hypnosis (Other)
Control group
Participants in the control group will receive standard post-discharge care, which includes mobilization, nutrition, pain control, and family engagement and empowerment, without any hypnosis intervention.
结局指标
主要结局
Wellbeing at day 28 post intensive care unit discharge
时间窗: Day 28 post intensive care unit discharge
ESAS scale (Edmonton Symptom Assessment System) with a range from 0 to 100. Higher scores means worse wellbeing.
次要结局
- PDI - Peritraumatic distress inventory(day 28 post ICU discharge)
- PHQ-9 - Patient Health Questionnaire-9(Day 28 post intensive care unit discharge and 3 months post intensive care)
- GAD-7 - Generalized Anxiety Disorder-7(at day 28 and 3 months post ICU discharge)
- IES-R (Impact of event Scale)(3 months post intensive care unit discharge. Higher score means more PTSD symptoms.)
- EQ-5D-5L (Quality of life)(Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge)
- PGIC - Patient Global Impression of Change(Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge)
- Immediate wellbeing following a hypnosis session(Day 1 (Day of discharge from ICU), day 7, day 14)
- HADS(Day 28 post intensive care unit discharge, 3 months, 6 months post intensive care)
- IES-R (Impact of event Scale)(Day 28 post intensive care unit discharge, 3 months, 6 months post intensive care unit discharge. Higher score means more PTSD symptoms.)
- SF-12 (Short Form 12-Item Health Survey)(Day 28 post intensive care unit discharge, 3 months, 6 months post intensive care unit discharge)
- EQ-5D-5L (Quality of life)(Day 28 post intensive care unit discharge, 3 months, 6 months post intensive care unit discharge)
- PGIC - Patient Global Impression of Change(Day 28 post intensive care unit discharge, 3 months, 6 months post intensive care unit discharge)
- PSQ - Patient Satisfaction Questionnaire (PSQ-18 short form)(Day 28 post intensive care unit discharge, 3 months, 6 months post intensive care unit discharge)
研究者
COEN Matteo
Dr. med. PD. PhD
University Hospital, Geneva