Clinical trial NCT06743321: Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Care Nursing
Keywords: ICU-acquired anxiety
Voice-cloning
Critical Care Nursing
Family-centered care
Artificial intelligence
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ICU-acquired anxiety
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of Delirium
timeFrame: 2 years
measure: Duration of Mechanical Ventilation
timeFrame: 2 years
measure: ICU Stay
timeFrame: 2 years
measure: ICU-acquired depression
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking union medical college hospital, ICU department
name: Yun Long, MD
role: STUDY_DIRECTOR
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