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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05732584
• Other study ID #: 2022-1013
• Status: Completed
• Phase: N/A
• Start date: March 25, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• structured 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.
• unstructured 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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delirium	use the Confusion Assessment Method for the ICU (CAM-ICU)	up to 5 days
Secondary	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
Secondary	delirium duration	use the Confusion Assessment Method for the ICU (CAM-ICU)	up to 5 days
Secondary	delirium-free days	use the Confusion Assessment Method for the ICU (CAM-ICU)	up to 5 days
Secondary	delirium subtype	use the Confusion Assessment Method for the ICU (CAM-ICU) and Richmond Agitation Sedation Scale(RASS)	up to 5 days
Secondary	time to first delirium	use the Confusion Assessment Method for the ICU (CAM-ICU)	up to 5 days
Secondary	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
Secondary	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
Secondary	Duration of mechanical ventilation	Duration of use of mechanical ventilation	up to 5 days