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

Primary Purpose

Delirium

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Family voice stimulation
Unfamiliar voice stimulation
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Delirium, Intensive Care Units, Auditory Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Family voice stimulation

Unfamiliar voice stimulation

Control group

Arm Description

Patients in this group were provided with structured family voice stimulation

Patients in this group were provided with structured unfamiliar voice stimulation

Patients in this group will receive no specific voice stimulation

Outcomes

Primary Outcome Measures

incidence of delirium
use the Confusion Assessment Method for the ICU (CAM-ICU)

Secondary Outcome Measures

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.
delirium duration
use the Confusion Assessment Method for the ICU (CAM-ICU)
delirium-free days
use the Confusion Assessment Method for the ICU (CAM-ICU)
delirium subtype
use the Confusion Assessment Method for the ICU (CAM-ICU) and Richmond Agitation Sedation Scale(RASS)
time to first delirium
use the Confusion Assessment Method for the ICU (CAM-ICU)
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)
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)
Duration of mechanical ventilation
Duration of use of mechanical ventilation

Full Information

First Posted
February 8, 2023
Last Updated
April 20, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05732584
Brief Title
Effect of Auditory Stimulation by Family Voices in Preventing Delirium: A Randomized Controlled 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Intensive Care Units, Auditory Stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
213 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Family voice stimulation
Arm Type
Experimental
Arm Description
Patients in this group were provided with structured family voice stimulation
Arm Title
Unfamiliar voice stimulation
Arm Type
Experimental
Arm Description
Patients in this group were provided with structured unfamiliar voice stimulation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in this group will receive no specific voice stimulation
Intervention Type
Other
Intervention Name(s)
Family voice stimulation
Intervention Description
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
Intervention Name(s)
Unfamiliar voice stimulation
Intervention Description
The structured unfamiliar 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
Primary Outcome Measure Information:
Title
incidence of delirium
Description
use the Confusion Assessment Method for the ICU (CAM-ICU)
Time Frame
up to 5 days
Secondary Outcome Measure Information:
Title
delirium severity
Description
use Confusion Assessment Method for the Intensive Care Unit 7-item (CAM-ICU-7), ranging from 0-7 , higher scores means higher delirium severity.
Time Frame
up to 5 days
Title
delirium duration
Description
use the Confusion Assessment Method for the ICU (CAM-ICU)
Time Frame
up to 5 days
Title
delirium-free days
Description
use the Confusion Assessment Method for the ICU (CAM-ICU)
Time Frame
up to 5 days
Title
delirium subtype
Description
use the Confusion Assessment Method for the ICU (CAM-ICU) and Richmond Agitation Sedation Scale(RASS)
Time Frame
up to 5 days
Title
time to first delirium
Description
use the Confusion Assessment Method for the ICU (CAM-ICU)
Time Frame
up to 5 days
Title
family anxiety levels
Description
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)
Time Frame
up to 5 days
Title
family depression levels
Description
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)
Time Frame
up to 5 days
Title
Duration of mechanical ventilation
Description
Duration of use of mechanical ventilation
Time Frame
up to 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingfen Jin, Master
Phone
+86-0571-87783887
Email
zrjzkhl@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingfen Jin, Master
Organizational Affiliation
The Second Affiliated Hospital of Medical College of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfen Jin, Master
Phone
+86-0571-87783887
Email
zrjzkhl@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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