The aim of this study is to evaluate the effect of playing a familiar voice in reduction of agitation in patients admitted in the Intensive Care Unit.
Design
This is a clinical trial with a control group, with parallel, non-blind, and randomized groups which was randomized by using a computer software for defining the blocks.
Settings and conduct
This study is conducted in Shahid Beheshti Hospitals, including Shohada Tajrish Hospital and Taleghani Hospital, and the intervention is performed as playing a familiar voice for patients (voice record of family members) three times a day in the morning and evening, each time for 30 minutes and totally for 3 days.
Participants/Inclusion and exclusion criteria
The inclusion criteria: Age between 18 and 65;
The agitation rate based on the Richmond criterion is between 1+ and 2+;
The complete health of the patient's hearing system;
The exclusion criteria:
History of neurological diseases such as Alzheimer's disease, dementia, stroke;
The history of drug addiction;
History of mental illness
Intervention groups
In the intervention group, a familiar voice record (the recorded sound of a patient's acquaintance, containing relaxing and hopeful sentences) will be played for them. the control group consists of agitated patients who have been admitted to the same intensive care unit and the usual care will be provided for them.
Main outcome variables
Agitation rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170701034837N2
Registration date:2018-03-14, 1396/12/23
Registration timing:retrospective
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
hasti ansari ashlaghi
Name of organization / entity
shahid beheshti university
Country
Iran (Islamic Republic of)
Phone
+98 88061058
Email address
h.ansari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
researcher
Expected recruitment start date
2016-09-26, 1395/07/05
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-02-08, 1395/11/20
Trial completion date
empty
Scientific title
Evaluating the Effect of Familiar Voice on Decrease of Agitation in Patients in Intensive Care Unit
Public title
Effect of Familiar Voice on Decrease of Patient's Agitation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65
The agitation rate based on the Richmond criterion is between 1+ and 2+
Complete health of the patient's hearing system
Exclusion criteria:
History of neurological diseases such as Alzheimer's disease, dementia, stroke
The history of drug addiction
History of mental illness
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method was used which the patient was the randomization unit. For this purpose, computer software was used to define the blocks and the allocation concealment was not applicable in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Iran, Evin, Tehran, Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2016-07-26, 1395/05/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.247
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Agitation
Timepoint
Measurements will be done before the intervention in each day and at the end of the study.
Method of measurement
Richmond Agitation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Familiar voice (the sound of favorite relatives of the patient) for 30 minutes, two times a day in the morning and evening for 3 days
Category
Prevention
2
Description
Control group: common care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Hasti Ansari Ashlaghi
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
56845342
Phone
+98 21 8806 1058
Email
pr_shohada@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Hasti Ansari Ashlaghi
Street address
Tabnak St., Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
9854324678
Phone
+98 21 2243 2560
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Shokri
Street address
Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2263
Email
info.ece@cc.sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?