What question did this study set out to answer?

This trial aims to evaluate the impact of voice-cloning care on ICU-acquired anxiety in critically ill patients.

March 6, 2026BMJ Open0 citationsOpen Access

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

Key Points

This trial aims to evaluate the impact of voice-cloning care on ICU-acquired anxiety in critically ill patients.
Enrolling 234 adult ICU patients requiring mechanical ventilation for over 24 hours.
Randomly assigning participants to control (standardized communication) or intervention (SVCC) groups.
Using cloned voices of family members to deliver communication scripts during specific care moments.
Intervention group is expected to show reduced ICU-acquired anxiety as measured by the Hospital Anxiety and Depression Scale.
Secondary outcomes include lower rates of ICU-acquired depression and delirium.
The study may also affect the mean duration of mechanical ventilation and ICU stay length.

Abstract

Introduction Intensive care unit (ICU) visiting restrictions in hospitals, implemented due to infection control and other factors, limited contact between patients and family members, affecting patients’ well-being and clinical outcomes. With the evolution of voice-cloning based on artificial intelligence (AI) technology, it has become possible for health providers to communicate with critically ill patients using highly similar synthetic voices of their loved ones during ICU care. This current randomised, controlled trial will explore the effect of voice-cloning care on improving mental health outcomes for critically ill patients, with ICU-acquired anxiety as the primary indicator. Methods and analysis This study will enrol 234 adult ICU patients, who are expected to require mechanical ventilation for over 24 hours and an ICU stay exceeding 72 hours. Participants will be randomly assigned to two groups. The control group will receive standardised communication as part of usual ICU care, while the intervention group will receive Speech-to-Speech Voice-Cloning Care (SVCC) in addition to standard ICU care. The SVCC interventions involve nurses using a participant’s family member’s cloned voice to deliver pre-set communication scripts during awakening, soothing and preparation for endotracheal tube removal. The primary outcome is expected to lead to improvements in ICU-acquired anxiety for the intervention group, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes include ICU-acquired depression, the incidence of delirium, the mean duration of mechanical ventilation and the average length of ICU stay. Ethics and dissemination This protocol was approved by the Ethics Committee of Peking Union Medical College Hospital (Approval Number: K-6842). The protocol version number is 1.2 and the version date is 8 October 2024. Study findings will be disseminated through peer-reviewed publications and presentations at national and international conferences. Trial registration number ClinicalTrials.gov, ID: NCT06743321 .

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