Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06743321

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Critical Care Nursing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yingying Yang, MD

CONTACT

[email protected]

+8618800173833

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

A Prospective Study of the Effectiveness of Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.