Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients

Официальное название

A Prospective Study of the Effectiveness of Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Speech-to-speech Voice-Cloning Care (SVCC)
  After patients in the intervention group were transferred to the ICU, the SVCC intervention was initiated. It is administered three times daily: in the morning, at noon, and in the evening. The SVCC intervention includes three types of activities: awakening, reassurance, and preparatory exercises for the removal of the endotracheal tube (ETT). Before each intervention is carried out, the clinical status of the participants must be assessed to determine whether they are suitable for SVCC and to d

Первичные конечные точки

• ICU-acquired anxiety [Срок оценки: Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge.]

Вторичные конечные точки (5)

• ICU-acquired depression [Срок оценки: Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge.]
• Incidence of Delirium [Срок оценки: Twice daily from Day 1 through ICU discharge, an average of 7 days.]
• Duration of Mechanical Ventilation [Срок оценки: From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.]
• ICU Stay [Срок оценки: From ICU admission through ICU discharge, an average of 7 days.]
• Qualitative assessment [Срок оценки: Once during the follow-up visit, three days after the participant is discharged from the ICU.]

Критерии участия

Критерии включения

• Expected mechanical ventilation time > 24 hours;
• Expected ICU stay > 72 hours;
• Language: Chinese;
• Richmond Agitation-Sedation Scale (RAAS) score ≥ -2 points;
• Hemodynamic stability.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Публикации

• Novaes MA, Knobel E, Karam CH, Andreoli PB, Laselva C. A simple intervention to improve satisfaction in patients and relatives. Intensive Care Med. 2001 May;27(5):937. doi: 10.1007/s001340100910. No abstract available. PMID 11430555
• Cray L. A collaborative project: initiating a family intervention program in a medical intensive care unit. Focus Crit Care. 1989 Jun;16(3):213-8. PMID 2737344
• May AD, Parker AM, Caldwell ES, Hough CL, Jutte JE, Gonzalez MS, Needham DM, Hosey MM. Provider-Documented Anxiety in the ICU: Prevalence, Risk Factors, and Associated Patient Outcomes. J Intensive Care Med. 2021 Dec;36(12):1424-1430. doi: 10.1177/0885066620956564. Epub 2020 Oct 9. PMID 33034254
• Fond G, Nemani K, Etchecopar-Etchart D, Loundou A, Goff DC, Lee SW, Lancon C, Auquier P, Baumstarck K, Llorca PM, Yon DK, Boyer L. Association Between Mental Health Disorders and Mortality Among Patients With COVID-19 in 7 Countries: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 Nov 1;78(11):1208-1217. doi: 10.1001/jamapsychiatry.2021.2274. PMID 34313711
• Rabiee A, Nikayin S, Hashem MD, Huang M, Dinglas VD, Bienvenu OJ, Turnbull AE, Needham DM. Depressive Symptoms After Critical Illness: A Systematic Review and Meta-Analysis. Crit Care Med. 2016 Sep;44(9):1744-53. doi: 10.1097/CCM.0000000000001811. PMID 27153046
• Scragg P, Jones A, Fauvel N. Psychological problems following ICU treatment. Anaesthesia. 2001 Jan;56(1):9-14. doi: 10.1046/j.1365-2044.2001.01714.x. PMID 11167429
• Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May;43(5):1121-9. doi: 10.1097/CCM.0000000000000882. PMID 25654178
• Cuthbertson BH, Scott J, Strachan M, Kilonzo M, Vale L. Quality of life before and after intensive care. Anaesthesia. 2005 Apr;60(4):332-9. doi: 10.1111/j.1365-2044.2004.04109.x. PMID 15766335

Идентификаторы

NCT: NCT06743321 · K6842

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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