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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

China · 1 center

• Peking Union Medical College Hospital — Beijing

Publications

• 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

Identifiers

NCT: NCT06743321 · K6842

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗