NCT05732584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

February 8, 2023

Last Update Submit

February 27, 2024

Conditions

Delirium

Keywords

DeliriumIntensive Care UnitsAuditory Stimulation

Outcome Measures

Primary Outcomes (1)

  • incidence of delirium

    use the Confusion Assessment Method for the ICU (CAM-ICU)

    up to 5 days

Secondary Outcomes (8)

  • delirium severity

    up to 5 days

  • delirium duration

    up to 5 days

  • delirium-free days

    up to 5 days

  • delirium subtype

    up to 5 days

  • time to first delirium

    up to 5 days

  • +3 more secondary outcomes

Study Arms (3)

structured family voice stimulation

EXPERIMENTAL

Patients in this group were provided with structured family voice stimulation

Other: structured family voice stimulation

unstructured family voice stimulation

EXPERIMENTAL

Patients in this group were provided with unstructured family voice stimulation

Other: unstructured family voice stimulation

Control group

NO INTERVENTION

Patients in this group will receive no specific voice stimulation

Interventions

structured family voice stimulationOTHER

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.

structured family voice stimulation
unstructured family voice stimulationOTHER

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

unstructured family voice stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Jingfen Jin, Master

    The Second Affiliated Hospital of Medical College of Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

March 25, 2023

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

February 28, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)