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

NCT06743321 | Not Yet Recruiting DMC

• 1 other identifier: K6842
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Care Nursing

Keywords

ICU-acquired anxiety; Voice-cloning; Critical Care Nursing; Family-centered care; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• ICU-acquired depression

  Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge.

• Incidence of Delirium

  Twice daily from Day 1 through ICU discharge, an average of 7 days.

• Duration of Mechanical Ventilation

  From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.

• ICU Stay

  From ICU admission through ICU discharge, an average of 7 days.

• Qualitative assessment

  Once during the follow-up visit, three days after the participant is discharged from the ICU.

Study Arms (2)

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.

Behavioral: Speech-to-speech Voice-Cloning Care (SVCC)

The controlled group

NO INTERVENTION

Patients in the controlled group will only receive standard ICU care.

Interventions

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.

The intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (12)

• 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 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.

  PMID: 2737344 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.

  PMID: 33034254 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.

  PMID: 34313711 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.

  PMID: 27153046 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.

  PMID: 11167429 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.

  PMID: 25654178 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.

  PMID: 15766335 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.

  PMID: 31142240 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.

  PMID: 32242994 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.

  PMID: 25376648 BACKGROUND

• 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.

  PMID: 41781048 DERIVED

Study Officials

• Yun Long, MD

  Peking union medical college hospital, ICU department

  STUDY DIRECTOR

Central Study Contacts

Yingying Yang, MD

CONTACT

+8618800173833; yangyingying2703@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The independent statistician conducting the interim analysis will be masking. The statistician analyzing the primary and secondary outcome data will also be masking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)