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

March 23, 2026 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 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.
No Intervention: The controlled group
Patients in the controlled group will only receive standard ICU care.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Twice daily from Day 1 through ICU discharge, an average of 7 days.
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
Time Frame: From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.
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
Time Frame: From ICU admission through ICU discharge, an average of 7 days.
The ICU stays are daily recorded by the physicians and nurses.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Director: Yun Long, MD, Peking union medical college hospital, ICU department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K6842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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