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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:
Researchers will see if the implementation of SVCC can reduce anxiety and depression and improve clinical outcomes.
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The intervention group | Experimental | Patients in the intervention group will receive Speech-to-Speech Voice-Cloning Care (SVCC) as an addition to their standard ICU care. |
|
| The controlled group | No Intervention | Patients in the controlled group will only receive standard ICU care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speech-to-speech Voice-Cloning Care (SVCC) | Behavioral | 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 decide on the specific content of the intervention. Once the removal of the ETT is implemented, the SVCC intervention will no longer be carried out. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU-acquired anxiety | The primary outcome assessment will be conducted using the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS is used to assess symptoms of anxiety and depression in medical patients, which includes two subscales: one for anxiety (HADS-A) and one for depression (HADS-D). Each subscale consists of seven items, with scores for each item ranging from 1 to 4. The total score for each subscale ranges from 7 to 28, with a score of 11 or above considered to be the critical value. | Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU-acquired depression | ICU-acquired depression is assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D). | Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge. |
| Incidence of Delirium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingying Yang, MD | Contact | +8618800173833 | yangyingying2703@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Yun Long, MD | Peking union medical college hospital, ICU department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11430555 | Background | 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. | |
| 2737344 | Background | 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. |
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IPD sharing is not applicable due to the risk of patient privacy breaches and the potential for tampering with or leakage of patients' family members' voice data.
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The independent statistician conducting the interim analysis will be masking. The statistician analyzing the primary and secondary outcome data will also be masking.
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The incidence of delirium is monitored and evaluated by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU has four items: (1) altered mental status/fluctuating course, (2)inattention, (3) altered level of consciousness, and (4) disorganized thinking. Each item has two factors (positive or negative). The physicians can diagnose the patients with delirium when the results of item (1), item (2), and item (3) or item (4) are positive. |
| Twice daily from Day 1 through ICU discharge, an average of 7 days. |
| Duration of Mechanical Ventilation | The duration of mechanical ventilation is daily recorded by the physicians and nurses. | From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days. |
| ICU Stay | The ICU stays are daily recorded by the physicians and nurses. | From ICU admission through ICU discharge, an average of 7 days. |
| Qualitative assessment | To assess subjective patient experiences, brief, semi-structured interviews will be conducted with a subset of eligible participants in the intervention group to explore their perceptions, acceptance, and the impact of the voice-cloning intervention. | Once during the follow-up visit, three days after the participant is discharged from the ICU. |
| 33034254 | Background | 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. |
| 34313711 | Background | 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. |
| 27153046 | Background | 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. |
| 11167429 | Background | 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. |
| 25654178 | Background | 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. |
| 15766335 | Background | 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. |
| 31142240 | Background | Jacques T, Ramnani A, Deshpande K, Kalfon P. Perceived Discomfort in Patients admitted to Intensive Care (DETECT DISCOMFORT 1): a prospective observational study. Crit Care Resusc. 2019 Jun;21(2):103-109. |
| 32242994 | Background | Berntzen H, Bjork IT, Storsveen AM, Woien H. "Please mind the gap": A secondary analysis of discomfort and comfort in intensive care. J Clin Nurs. 2020 Jul;29(13-14):2441-2454. doi: 10.1111/jocn.15260. Epub 2020 Apr 17. |
| 25376648 | Background | Baumgarten M, Poulsen I. Patients' experiences of being mechanically ventilated in an ICU: a qualitative metasynthesis. Scand J Caring Sci. 2015 Jun;29(2):205-14. doi: 10.1111/scs.12177. Epub 2014 Nov 7. |
| 41781048 | Derived | Li M, Yang Y, Hao J, Xue Y, Weng D, Jiang H, Song W, Yang Y, Long Y. Speech-to-Speech Voice-Cloning Care (SVCC) for improving ICU-acquired anxiety for critically ill patients in a tertiary hospital in Beijing, China: protocol of a randomised, controlled trial. BMJ Open. 2026 Mar 4;16(3):e101227. doi: 10.1136/bmjopen-2025-101227. |