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Effect of Auditory Stimulation by Family Voices in Preventing Delirium: A Randomized Controlled Trial

Effect of Auditory Stimulation by Family Voices in Preventing Delirium Among Sedative Patients in Emergency Intensive Care Units :A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05732584
Enrollment
213
Registered
2023-02-17
Start date
2023-03-25
Completion date
2023-11-15
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Delirium, Intensive Care Units, Auditory Stimulation

Brief summary

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.

Detailed description

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.

Interventions

OTHERstructured family voice stimulation

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.

OTHERunstructured family voice stimulation

The unstructured family voice stimulation is played to the patients for the first five days after admission to eicu until transfer out or death.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* transferred to the EICU from emergency admission * no other history of emergency, surgery, or ICU admission history within 30 days * no delirium in the first screening of Emergency Intensive Care Unit(EICU) admission * with an expected length of stay in EICU longer than 24h and use of sedation medication

Exclusion criteria

* Presence of hearing impairment, severe dementia, psychiatric disorder, or other severe brain dysfunction that hinders delirium assessment * persistent coma or deep sedation (RASS score of -4 to -5) * patients without a family member who can cooperate with the recording * external ear disease or surgery that hinders earphone wearing

Design outcomes

Primary

MeasureTime frameDescription
incidence of deliriumup to 5 daysuse the Confusion Assessment Method for the ICU (CAM-ICU)

Secondary

MeasureTime frameDescription
delirium durationup to 5 daysuse the Confusion Assessment Method for the ICU (CAM-ICU)
delirium-free daysup to 5 daysuse the Confusion Assessment Method for the ICU (CAM-ICU)
delirium subtypeup to 5 daysuse the Confusion Assessment Method for the ICU (CAM-ICU) and Richmond Agitation Sedation Scale(RASS)
delirium severityup to 5 daysuse Confusion Assessment Method for the Intensive Care Unit 7-item (CAM-ICU-7), ranging from 0-7 , higher scores means higher delirium severity.
family anxiety levelsup to 5 daysfamilies 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)
family depression levelsup to 5 daysfamilies 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)
Duration of mechanical ventilationup to 5 daysDuration of use of mechanical ventilation
time to first deliriumup to 5 daysuse the Confusion Assessment Method for the ICU (CAM-ICU)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026