Effects of calm music on physiological indexes ( Oxygen saturation,heart rate,respiratory rate, systolic, diastolic blood pressure,main arterial pressure, Pulse pressure and central tempreture) of patients with traumatic brain injuries in intensive care units of shahid beheshti medical university hospitals in 2011
The purpose of this research is evaluation of light music on physiological parameters of patients with traumatic brain injuries at intensive care units of teaching hospitals affiliated with Shaheed Beheshti Medical University. This research is a quasi-experimental study in which 35 patients with traumatic brain injuries will be enrolled. Physiological parameters and level of consciousness (LOC) of subjects will be measured and compared at 5 minute before and after the end 10 minutes of listening to light music.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012145392N1
Registration date:2011-05-16, 1390/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-16, 1390/02/26
Registrant information
Name
Marzieh Maleki
Name of organization / entity
Shaheed Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 2224 3293
Email address
mmaleki@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaheed Beheshti University of Medical Sciences
Expected recruitment start date
2011-05-02, 1390/02/12
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of calm music on physiological indexes ( Oxygen saturation,heart rate,respiratory rate, systolic, diastolic blood pressure,main arterial pressure, Pulse pressure and central tempreture) of patients with traumatic brain injuries in intensive care units of shahid beheshti medical university hospitals in 2011
Public title
Music therapy in patients with head injuries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: presence of traumatic brain injuries at intensive care units (ICU), GCS between 8 to 10, stable hemodynamic situation (e.g. fluid and electrolytes), no any auditory defects, not receiving continues IV sedative drugs, age 18 to 49 years old, no admission more than one month
Exclusion criteria: imbalance hemodynamic or death, GCS decreased to less than 8 or increased more than 10 during the intervention phase
Age
From 18 years old to 63 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Beheshti University of Medical Sciences
Street address
Shaheed Beheshti University of Medical Sciences, beside the Taleqani hospital, Yaman St, Shaheed Chamran highway
City
Tehran
Postal code
1985717443
Approval date
2011-05-02, 1390/02/12
Ethics committee reference number
89-01-86-7473-5471
Health conditions studied
1
Description of health condition studied
head Injuries
ICD-10 code
S00
ICD-10 code description
Injures to head
Primary outcomes
1
Description
Respiratory rate
Timepoint
5 minute before music lisening, at the end of music lisening And 10 minute after that
Method of measurement
Observation the chest movements( up and down movements) in rate per minute
2
Description
Heart rate
Timepoint
5 minute before music lisening, at the end of music lisening And 10 minute after that
Method of measurement
Radial pulse palpation, in rate per minute
3
Description
Pripheral artrial oxygen saturetion(SPO2)
Timepoint
5 minute before music lisening, at the end of music lisening And 10 minute after that
Method of measurement
pulse oxymeter in percent
4
Description
Systolic blood pressure
Timepoint
5 minute before music lisening, at the end of music lisening And 10 minute after that
Method of measurement
Sphyngomanometer in mmhg
5
Description
Diastolic blood pressure
Timepoint
5 minute before music lisening, at the end of music lisening And 10 minute after that
Method of measurement
Sphyngomanometer in mmhg
6
Description
Central body tempreture
Timepoint
5 minute before music lisening, at the end of music lisening And 10 minute after that
Method of measurement
Tympanic thermometer in centigrad degree
7
Description
Mean Arterial Pressure
Timepoint
5 minute before music lisening, at the end of music lisening And 10 minute after that
Method of measurement
Physiological Parameters form
8
Description
Pulse pressure
Timepoint
5 minute before music lisening, at the end of music lisening And 10 minute after that
Method of measurement
Physiological Parameters form
Secondary outcomes
1
Description
level of consciousness
Timepoint
befor and after music lisening
Method of measurement
Glassgow Coma Scale (GCS)
Intervention groups
1
Description
Light Music : The patient will listen to light music for sequence of 3 days at 16 to 18 oclock for 15 minutes each session through headphone.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadye Tajrish Hospital
Full name of responsible person
Mahnaz Nik Peyma(MSN)
Street address
Tajrish Square
City
Tehran
2
Recruitment center
Name of recruitment center
Hakim Loqman Hospital
Full name of responsible person
Fatemeh Goodarzi (MSN)
Street address
Hakim Loqman Hospital, Kamal St, Lashkar crossroads, South Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences. nursing midwfery college
Full name of responsible person
Mohammad Ghaderi
Street address
Nursing midwfery college,crossroads valieaser with niaiesh,valieaser St.
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences. nursing midwfery college
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing midwifery college,Shaheed Beheshti Medical Sciences university.
Full name of responsible person
Marzieh Maleki
Position
MSN, team leader in clinical skills
Other areas of specialty/work
Street address
Nursing midwfery college, crossroads valieaser with niaiesh,valieaser St
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
-
Email
mmaleki@sbmu.ac.ir,mmaleki5@yahoo.com
Web page address
sbnmf@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Beheshti nursing midwifery Coleage
Full name of responsible person
Marzieh Maleki
Position
MSN ,team leader in clinical skills
Other areas of specialty/work
Street address
Nursing midwfery college, crossroads valieaser with niaiesh,valieaser St.
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
Email
mmaleki5@yahoo.com, mmaleki@sbmu.ac.ir
Web page address
sbnmf@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Beheshti nursing midwifery College
Full name of responsible person
Mohammad Ghaderi
Position
Master nursing student
Other areas of specialty/work
Street address
Nursing midwfery college, crossroads valieaser with niaiesh,valieaser St
City
Tehran
Postal code
9698113879
Phone
+98 53 3622 4610
Fax
-
Email
ghaderi.mohammad1@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)