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

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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Other: structured family voice stimulation; Other: unstructured family voice stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients in this group will receive no specific voice stimulation
Experimental: structured family voice stimulation; Patients in this group were provided with structured family voice stimulation	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.
Experimental: unstructured family voice stimulation; Patients in this group were provided with unstructured family voice stimulation	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of delirium	use the Confusion Assessment Method for the ICU (CAM-ICU)	up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delirium duration	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
Duration of mechanical ventilation	Duration of use of mechanical ventilation	up to 5 days
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Intensive Care Units; Delirium; Auditory Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2022-1013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No