The results of this study may increase the level of alertness of head injured patients in the intensive care unit and promote the use of non-pharmacological treatments, such as music in special units
Design
A clinical trial design with a control group, single blind, randomized
Settings and conduct
The study will be conducted in Shahid Rajaee and razi hospitals in Qazvin for 7 days.
Participants/Inclusion and exclusion criteria
Patients aged 18-65 years old.
The level of consciousness based on Glasgow coma scale is less than 8.
The patient is admitted with a diagnosis of trauma brain injury including subdural , epidural, intracerebral, ventricular and subarachnoid hemorrhage.
The setation is based on the Richmond criteria in the range of 2+ to 2.
48 hours from the time of admission.
exclusion criteria:
discontent of the patient's companions to continue the study.
Patients with vegetable status according to doctor's diagnosis.
Patients with severe previous head injury.
The history of alcohol use and pre-incident drug use according to family statements.
Loss of consciousness is suddenly more than 3 scores based on the Glasgow coma scale during the intervention.
Intervention groups
In the intervention group, smooth and unconventional beach walking, Stein will be selected from the Top-Hits zum Entspannen Vol.1 album. This music will be played in the intervention group with a beat of 60 to 80 beats per minute with MP3 PLAYER for 15 minutes. Music selected once a day ,Music will be at 16-18 pm, Music will be played through headphones for 7 days.The control group will only receive the usual activities of the department
Main outcome variables
level of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190106042259N1
Registration date:2019-02-19, 1397/11/30
Registration timing:prospective
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
saeedeh doust mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3523 9125
Email address
s.doustmohammadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of music on the level of consciousness of Traumatic brain injury patients
Public title
The Impact of Music on the Level of consciousness the traumatic brain injury patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-65 years old
The level of consciousness based on Glasgow coma scale less than 8
The patient is admitted with a diagnosis of. traumatic brain injury including subdural , epidural, intracerebral, ventricular and subarachnoid hemorrhage.
The sedation is based on the Richmond critera in the range of 2+ to 2
24 hours after vital signs are stable
No previous hearing loss is reported by the family
No Dressing in the ear
According to the orthopedics doctor, patients should have at least one healthy hearing position
Exclusion criteria:
Dissatisfaction the companions of the patient to continue participating in the study
Patients with vegetable status according to doctor's diagnosis
The history of alcohol use and pre-incident drug use according to family statements.
Loss of consciousness is suddenly more than 3 scores based on the Glasgow coma scale during the intervention.
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:
54
More than 1 sample in each individual
Number of samples in each individual:
27
The research units will include patients who have entered the research criteria and will enter the study in two groups of control and Intervention. 54 patients (women and men) will be placed in two groups of intervention and control, each of which will contain 27 samples. Satisfaction will be taken from executor patient. Patients with an alertness level of less than 8 scores based on the Glasgow coma scale will be selected
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected by convenient sampling method. Using simple random sampling method, two groups of intervention and control using separate drawings of two red and white balls (without placement) will be performed, so that the white ball indicates the control group And the red ball indicates the intervention group
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 Qazvin University of Medical Sciences
Street address
Shafa hospital,Fakuri street,Takestan,Qazvin-
City
Qazvin
Province
Qazvin
Postal code
3481993656
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.QUMS.REC.1397.276
Health conditions studied
1
Description of health condition studied
Level of consciousness in traumatic brain injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
level of consciousness
Timepoint
The level of consciousness will be measured for 7 days 5 minutes before the performance and 10 minutes after the completion of the music
Method of measurement
level of consciousness will be measured based on Glasgow coma scale
Secondary outcomes
empty
Intervention groups
1
Description
Music intervention in the intervention group will be performed through a part of the work of Arend Stein for 7 sessions and 15 minutes through the headphones.
Category
Rehabilitation
2
Description
Control group: The control group will receive routine care only
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei and Razi Hospital in Qazvin city
Full name of responsible person
Saeedeh doust mohammadi
Street address
Shafa hospital,Fakouri street,Takestan,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3481993656
Phone
+98 28 3523 9125
Email
saeedeh.dm6475@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Saeedeh doust mohammadi
Street address
Shafa hospital,Fakuri street,Takestan,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3481993656
Phone
+98 28 3523 9125
Email
saeedeh.dm6475@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
50
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
Qazvin University of Medical Sciences
Full name of responsible person
Saeedeh doust mohammadi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shafa hospital,Fakuri street
City
Takestan
Province
Qazvin
Postal code
3481993656
Phone
+98 28 3523 9125
Email
saeedeh.dm6475@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
saeedeh doust mohammadi
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shafa hospital,Fakuri street
City
takestan
Province
Qazvin
Postal code
3481993656
Phone
+98 28 3523 9125
Email
saeedeh.dm6475@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Saeedeh duost mohammadi
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shafa hospital,fakuri sreet
City
Takestan
Province
Qazvin
Postal code
3481993656
Phone
+98 28 3523 9125
Email
saeedeh.dm6475@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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main consequence of sharing is possible
When the data will become available and for how long
One year after the start of sampling
To whom data/document is available
All people
Under which criteria data/document could be used
In order to use in traumatic care units to increase the level of consciousness in patients with truamatic brain injury
From where data/document is obtainable
Qazvin University of Medical Sciences
What processes are involved for a request to access data/document
The data will be collected by the researcher after receipt of the clinical trial code and the written consent of the patient.