Critical Care NursingNCT06743321
Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients
A study testing Speech-to-speech Voice-Cloning Care (SVCC) in people with Critical Care Nursing, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care Nursing
- What is being tested?
- Speech-to-speech Voice-Cloning Care (SVCC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expected mechanical ventilation time > 24 hours;
- Expected ICU stay > 72 hours;
- Language: Chinese;
- Richmond Agitation-Sedation Scale (RAAS) score ≥ -2 points;
- Hemodynamic stability.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
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
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.
Read the 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.
- Conditions
- Critical Care Nursing
- Being tested
- Speech-to-speech Voice-Cloning Care (SVCC)
- Keywords
- ICU-acquired anxiety, Voice-cloning, Critical Care Nursing, Family-centered care, Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech-to-speech Voice-Cloning Care (SVCC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Speech-to-speech Voice-Cloning Care (SVCC) |
| The controlled group | No intervention | Patients in the controlled group will only receive standard ICU care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
ICU-acquired depression is assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D).
Measured: Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge.
Incidence of Delirium
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Once during the follow-up visit, three days after the participant is discharged from the ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Aug 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Critical Care NursingStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, MD, Study director, Peking union medical college hospital, ICU department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743321
- Sponsor's protocol ID
- K6842
- Status last verified
- Nov 2025
- First submitted
- 16 Dec 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 11430555Cray L. A collaborative project: initiating a family intervention program in a medical intensive care unit. Focus Crit Care. 1989 Jun;16(3):213-8.
PubMed 2737344May 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.
PubMed 33034254Fond 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.
PubMed 34313711Rabiee 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.
PubMed 27153046Scragg 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.
PubMed 11167429Parker 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.
PubMed 25654178Cuthbertson 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.
PubMed 15766335Jacques 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.
PubMed 31142240Berntzen 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.
PubMed 32242994Baumgarten 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.
PubMed 25376648Li 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.
PubMed 41781048
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06743321
- Acronym / sponsor ID
- K6842
- Conditions
- Critical Care Nursing
- Keywords
- ICU-acquired anxiety, Voice-cloning, Critical Care Nursing, Family-centered care, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Speech-to-speech Voice-Cloning Care (SVCC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Expected mechanical ventilation time > 24 hours;
- Expected ICU stay > 72 hours;
- Language: Chinese;
- Richmond Agitation-Sedation Scale (RAAS) score ≥ -2 points;
- Hemodynamic stability.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | The intervention group |
Primary outcome
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.
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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 11430555Novaes 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.
- Background: PubMed 2737344Cray L. A collaborative project: initiating a family intervention program in a medical intensive care unit. Focus Crit Care. 1989 Jun;16(3):213-8.
- Background: PubMed 33034254May 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.
- Background: PubMed 34313711Fond 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.
- Background: PubMed 27153046Rabiee 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.
- Background: PubMed 11167429Scragg 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.
- Background: PubMed 25654178Parker 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.
- Background: PubMed 15766335Cuthbertson 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.
- Background: PubMed 31142240Jacques 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.
- Background: PubMed 32242994Berntzen 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.
- Background: PubMed 25376648Baumgarten 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.
- Derived from this study: PubMed 41781048Li 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun Long, MD study director
Peking union medical college hospital, ICU department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech-to-speech Voice-Cloning Care (SVCC) in people with Critical Care Nursing, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingying Yang, MD (+8618800173833, yangyingying2703@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743321, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.