Comparison the effect of auditory stimulation with a familiar voice and the familiar environment reconstruction on delirium of patients admitted to the ICU: A parallel randomized clinical trial
Comparison of the effect of auditory stimulation with familiar language and reconstruction of familiar environment on delirium in patients hospitalized in the intensive care unit (ICU).
Design
The present study is a parallel randomized clinical trial. The sample size of 111 people was obtained by statistical calculations and people will be randomly divided into a control group and two intervention groups. There is no blinding in this study.
Settings and conduct
The place of study is Imam Hossein and Bahar hospital in Shahrood city. The questionnaire will be administered before the intervention, the day after the hospitalization, twice in the morning and in the evening, and will continue until the end of the hospitalization.
Participants/Inclusion and exclusion criteria
Admission: people over 18 years old; 24 hours have passed since admission to the intensive care unit; the patient is conscious and not on a ventilator; the level of consciousness based on GCS is greater than or equal to 10, and a close family member of the patient is available. Non-entry: history of alcohol consumption; connection to a ventilator; people in need of special treatment; history of psychiatric disorders and use of drugs with delusions and hallucinations.
Intervention groups
The present study includes 2 intervention groups (group A = auditory stimulation with familiar language), (group B = reconstruction of familiar environment) and a control group with routine care.
Main outcome variables
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240811062720N1
Registration date:2024-08-22, 1403/06/01
Registration timing:prospective
Last update:2024-08-22, 1403/06/01
Update count:0
Registration date
2024-08-22, 1403/06/01
Registrant information
Name
Fatemeh Moslemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4478 8379
Email address
fatemehmoslemi1377@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of auditory stimulation with a familiar voice and the familiar environment reconstruction on delirium of patients admitted to the ICU: A parallel randomized clinical trial
Public title
Comparison the effect of auditory stimulation with a familiar voice and the familiar environment reconstruction on delirium of patients admitted to the ICU: A parallel randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old
24 hours have passed since admission to the intensive care unit
The patient is awake and not on a ventilator
The level of consciousness of the patient should be greater than or equal to based on GCS
A close family member of the patient should be available
Exclusion criteria:
History of alcohol consumption
Connection to the ventilator
People in need of special treatment
History of psychiatric disorders
Using drugs with delusions and hallucinations
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
Because patients are gradually included in the study and also for the number of people assigned to each group to be equal, the block method with a volume of 6 will be used to create a random allocation sequence. In the current study, patients will be selected based on the researcher's desired criteria and by sequential sampling method, and based on the randomization software, the patients will be grouped into blocks of six and into three groups. A and group B and C will be placed. Then, randomly, the letter A is assigned to the intervention group, the letter B to the intervention group, and the letter C to the control group. The replacement arrangement will be done secretly. It means that there are 111 envelopes in the package, each of which contains the code A, B, and C. After it is determined that the desired person participates in the study, the researcher takes the desired envelope in the specified order and acts according to the group registered in the envelope.
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 Shahrood University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Approval date
2024-08-09, 1403/05/19
Ethics committee reference number
IR.SHMU.REC.1403.066
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium
Timepoint
Before the intervention, the next day of hospitalization in two shifts, morning and evening, continuing this process daily until the end of the hospitalization day
Intervention group: The intervention in group A is in the form of the presence of a close family member of the patient between 2 and 12 hours after admission and according to the patient's condition and talking to him for one consecutive hour. This intervention member cannot be moved during the test, and this action will be carried out until the end of the hospitalization day, at a specific time of the day, corresponding to the first day of admission.
Category
Prevention
2
Description
Intervention group: The intervention in group B is based on the fact that the family of hospitalized people will be asked about the memorable objects that the patient was interested in or used a lot, and after preparing a list of those objects, the family of the people will be asked. They are asked to provide the desired tools and then using the necessary tools, these objects will be fixed around the patient so that they do not disturb the support devices, and the necessary simulation will be provided for the desired patients.
Category
Prevention
3
Description
Control group: In the control group, visitors will be allowed to visit their patients in a limited way, according to the ward and hospital routine.
Faculty of Nursing and Midwifery, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 6714
Email
bagheri@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Behzad Garmabi
Street address
Faculty of Nursing and Midwifery, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 6714
Email
behzad.garmabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 6714
Email
bagheri@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 6714
Email
bagheri@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh moslemi
Position
master's student nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 6714
Email
fatemehmoslemi1377@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the demographic information and all the information related to the reconstruction of the familiar environment and the simulation of the familiar environment can be shared by maintaining confidentiality and not using the names of the participants.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Project partners
Under which criteria data/document could be used
For people doing similar research work.
From where data/document is obtainable
Correspondence should be addressed to the corresponding author: bagheri@shmu.ac.ir
What processes are involved for a request to access data/document