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

Not Applicable

Not yet recruiting

• Conditions: Critical Care Nursing

• Registration Number: NCT06743321
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Study Start: 2025-03-01
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ICU-acquired anxiety	2 years	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 Outcome Measures

Name	Time	Method
Incidence of Delirium	2 years	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.
Duration of Mechanical Ventilation	2 years	The duration of mechanical ventilation is daily recorded by the physicians and nurses.
ICU Stay	2 years	The ICU stays are daily recorded by the physicians and nurses.
ICU-acquired depression	2 years	ICU-acquired depression is assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D).

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China