Critical Care Nursing
Conditions
Keywords
ICU-acquired anxiety, Voice-cloning, Critical Care Nursing, Family-centered care, Artificial intelligence
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.
Interventions
BEHAVIORALSpeech-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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
The independent statistician conducting the interim analysis will be masking. The statistician analyzing the primary and secondary outcome data will also be masking.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU-acquired anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| ICU-acquired depression | 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). |
| Incidence of Delirium | 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. |
| Duration of Mechanical Ventilation | 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. |
| ICU Stay | From ICU admission through ICU discharge, an average of 7 days. | The ICU stays are daily recorded by the physicians and nurses. |
| Qualitative assessment | 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. |
Countries
China
Contacts
CONTACTYingying Yang, MD
STUDY_DIRECTORYun Long, MD
Peking union medical college hospital, ICU department
Outcome results
None listed