Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients
NCT ID: NCT06743321
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
234 participants
INTERVENTIONAL
2026-01-01
2026-12-31
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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The intervention group
Patients in the intervention group will receive Speech-to-Speech Voice-Cloning Care (SVCC) as an addition to their standard ICU care.
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 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.
The controlled group
Patients in the controlled group will only receive standard ICU care.
No interventions assigned to this group
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* Expected ICU stay \> 72 hours;
* Language: Chinese;
* Richmond Agitation-Sedation Scale (RAAS) score ≥ -2 points;
* Hemodynamic stability.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Yun Long, MD
Role: STUDY_DIRECTOR
Peking union medical college hospital, ICU department
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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K6842
Identifier Type: -
Identifier Source: org_study_id