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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Expected mechanical ventilation time > 24 hours;

Expected ICU stay > 72 hours;

Language: Chinese;

Richmond Agitation-Sedation Scale (RAAS) score ≥ -2 points;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

234 Participants
are divided into 2 treatment groups
Group A: The intervention groupExperimental treatment 1 intervention
Group B: The controlled groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

ICU-acquired anxiety

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.

Time frame
Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge.

Secondary outcomes

1

ICU-acquired depression

ICU-acquired depression is assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D).

Time frame
Baseline (Day 0); daily from ICU admission through ICU discharge (an average of 7 days); and 3 days post-ICU discharge.
2

Incidence of Delirium

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.

Time frame
Twice daily from Day 1 through ICU discharge, an average of 7 days.
3

Duration of Mechanical Ventilation

The duration of mechanical ventilation is daily recorded by the physicians and nurses.

Time frame
From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.
4

ICU Stay

The ICU stays are daily recorded by the physicians and nurses.

Time frame
From ICU admission through ICU discharge, an average of 7 days.

Other outcomes

Sponsors and contacts

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