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

NCT ID: NCT05732584

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-25
• Study Completion Date: 2023-11-15

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

structured family voice stimulation

Patients in this group were provided with structured family voice stimulation

Group Type: EXPERIMENTAL

structured family voice stimulation

Intervention Type: 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.

unstructured family voice stimulation

Patients in this group were provided with unstructured family voice stimulation

Group Type: EXPERIMENTAL

unstructured family voice stimulation

Intervention Type: 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.

Control group

Patients in this group will receive no specific voice stimulation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jingfen Jin, Master

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Medical College of Zhejiang University

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2022-1013

Identifier Type: -

Identifier Source: org_study_id