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Delirium is an acute cerebral dysfunction syndrome characterized by acute fluctuating changes in consciousness, cognitive dysfunction, and disorientation. It's especially common in critically ill patients of emergency intensive care units and seriously threatens the survival and prognosis of patients and causes heavy economic burdens to the family, society, and medical service system. Impaired verbal communication, unfamiliar medical personnel, physical restraint, spatial-temporal disorientation, mechanical ventilation and sedation medication use can lead to a lack of adequate sensory stimulation and a high risk of delirium. Acoustic stimulation as a non-invasive non-pharmacological intervention can provide some sensory stimulation as a surrogate for critically ill patients. This research designs the content scripts from the needs of ICU patients and families for sound stimulation. The goal of this randomized controlled study is to test the effect of auditory stimulation by family voices in preventing delirium among sedative patients in emergency Intensive care units.
Patients are separated from their families and society under the closed management of the intensive care unit, the use of sedative drugs, mechanical ventilation, impaired verbal communication, physical restraint, environmental noise, and prolonged light exposure, which lead to a lack of adequate sensory stimulation, causing sensory deprivation in patients to some extent. In turn, sensory deprivation may cause multisensory perceptual confusion and hallucinations, affecting patients' orientation and thinking and triggering delirium, so providing appropriate sensory stimulation to critically ill patients may help to improve patients' orientation and attention, correct patients' thinking confusion and prevent delirium, and in clinical practice, sensory stimulation is considered as an important part of multicomponent delirium prevention programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| structured family voice stimulation | Experimental | Patients in this group were provided with structured family voice stimulation |
|
| unstructured family voice stimulation | Experimental | Patients in this group were provided with unstructured family voice stimulation |
|
| Control group | No Intervention | Patients in this group will receive no specific voice stimulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| structured family voice stimulation | Other | The structured family voice stimulation is played to the patients for the first five days after admission to eicu until transfer out or death. The content of the recording is developed according to the structured script. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of delirium | use the Confusion Assessment Method for the ICU (CAM-ICU) | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| delirium severity | use Confusion Assessment Method for the Intensive Care Unit 7-item (CAM-ICU-7), ranging from 0-7 , higher scores means higher delirium severity. | up to 5 days |
| delirium duration |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jingfen Jin, Master | The Second Affiliated Hospital of Medical College of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| unstructured family voice stimulation | Other | The unstructured family voice stimulation is played to the patients for the first five days after admission to eicu until transfer out or death. |
|
use the Confusion Assessment Method for the ICU (CAM-ICU)
| up to 5 days |
| delirium-free days | use the Confusion Assessment Method for the ICU (CAM-ICU) | up to 5 days |
| delirium subtype | use the Confusion Assessment Method for the ICU (CAM-ICU) and Richmond Agitation Sedation Scale(RASS) | up to 5 days |
| time to first delirium | use the Confusion Assessment Method for the ICU (CAM-ICU) | up to 5 days |
| family anxiety levels | families were assessed using the Self-Rating Anxiety Scale (SAS) at the beginning and at the end of the intervention. (The score ranges from 25 to 100 and higher scores means more anxious situation) | up to 5 days |
| family depression levels | families were assessed using the Self-Rating Depression Scale (SDS) at the beginning and at the end of the intervention. (The score ranges from 25 to 100 and higher scores means more depressed situation) | up to 5 days |
| Duration of mechanical ventilation | Duration of use of mechanical ventilation | up to 5 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |