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The effect of Organized auditory stimulation with familiar voices on the level of consciousness and hemodynamic status of coma patients hospitalized in intensive care unit

Protocol summary

Summary
The purpose of this clinical trial is determining of The effect of Organized auditory stimulation with familiar voices on the level of consciousness and hemodynamic status of coma patients hospitalized in intensive care in PourSina hospital 92-93.The samples will be selected from comatose patients that would have admitted in the intensive care units of PourSina hospital of Rasht ,Iran.Then, the samples through an allocated randomizing Designed to case and control groups. The sample size is 60 head trauma comatose patients (30 interventional and 30 controls) that randomly allocated to the two groups.In this study Inclusion criteria are age of 16 above,GCS under 8 score in head trauma patients, Stable vital signs 24 hours after admission and duration of coma less than 72 hours.Duration of intervention is 3 days and every day 1 times (in afternoon shifts). Every auditory intervention is 10 minutes that after identifying a person of interest to the patient, will be recorded his/her voice in a quiet place and and broadcasted for each patient as auditory stimulation.The content of auditory stimulation for each subject includes: The Person introduces himself and aware patient of the time and place, Briefly explain to the patient what has happened to him/her,Then the sweet memories shared and hopeful,optimistic and encouraging in terms of improved patient returned to his family and future plans will be discussed.The GCS of each subject is monitored and recorded 5 minutes before and 5 minutes after auditory stimulation and hemodynamic function is assessed such as pulse and respiratory rate, blood pressure,mean arterial pressure,Temperature,2 minutes before and 2 minutes after auditory stimulation by a reasercher. Also, in the subjects as control group all of them are monitored without auditory stimulation. the data compare through statistic tests

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051517693N1
Registration date: 2014-08-14, 1393/05/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-14, 1393/05/23
Registrant information
Name
Mohammad Reza Yeganeh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5056
Email address
yeganeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Organized auditory stimulation with familiar voices on the level of consciousness and hemodynamic status of coma patients hospitalized in intensive care unit
Public title
The effect of Organized auditory stimulation with familiar voices on the level of consciousness and hemodynamic status of coma patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the admitted comatose patients in ICU with head trauma in the PourSina hospital of Rasht , Iran who have the following criteria will be selected: GCS≤8, Artificial airway (endotracheal tube - the mouth or nose - or tracheostomy), no have disorder or decrease in auditory function, no heart arrested for 4 minutes or upper, no having Precedence of : convulsion, brain damage, cardiovascular disease, fatty embolism, Rhinorrhea, otorrhea, fracture of basal skull, hemorrhage or surgery in temporal. exclusion criteria:Early death or discharge (before 3 days),Hemodynamic changes during intervention(A sudden increase or decrease in systolic and diastolic pressures over mmhg 20 compared to baseline,A sudden increase or decrease in heart rate over 20 beats to the base,Increased respiratory rate more than 25 and decreased more than 8 times per minute compared to the baseline)
Age
From 16 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Guilan University of Medical Sciences
Street address
Gillan - Rasht - Namjoo Street - opposite Azodi Stadium - Gilan University of Medical Sciences
City
Rasht
Postal code
65385-41446
Approval date
2014-07-07, 1393/04/16
Ethics committee reference number
2930162909

Health conditions studied

1

Description of health condition studied
Head Trauma,Brain injury,Intracranial injury
ICD-10 code
S09.7,S09.
ICD-10 code description
Multiple injuries of head,Other specified injuries of head,Intracranial injury

Primary outcomes

1

Description
level of consciousness
Timepoint
Once a day for three consecutive days
Method of measurement
GCS criteria

Secondary outcomes

1

Description
blood pressure
Timepoint
Once a day for three consecutive days
Method of measurement
blood pressure monitoring based on mm Hg

2

Description
Pulse
Timepoint
Once a day for three consecutive days
Method of measurement
pulse rate( counting) per minute by monitoring

3

Description
respiratory rate
Timepoint
Once a day for three consecutive days
Method of measurement
respiratory rate counting per minute

4

Description
body temperature
Timepoint
Once a day for three consecutive days
Method of measurement
With axillary thermometer based on C

Intervention groups

1

Description
Organized auditory stimuli in the intervention group for 3 days,Once daily (evening shift) for 10 minutes With the voice of a person of interest to the patient becomes sick auditory stimulation.The content of auditory stimulation for each subject includes: awareness about the location, time,Briefly explain to the patient what has happened to him/her,Then the sweet memories shared and hopeful,optimistic and encouraging in terms of improved patient returned to his family and future plans will be discussed
Category
Prevention

2

Description
The control group did not receive intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasht Poursina Hospital
Full name of responsible person
Mohammad Reza Yeganeh
Street address
Guilan,Rasht, Namjo street- Porsina Hospital
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Blvd. , Vice-Chancellor for Research of Guilan University of Medical Sciences
City
Rasht
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Guilan University of Medical Sciences
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
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Kazem Mohammadi
Position
MS of Critical care student (MSc)
Other areas of specialty/work
Street address
Iran-Gilan-Rasht
City
Rasht
Postal code
Phone
+98 13 1226 5049
Fax
Email
Mohammadkm64@Gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Reza Yeganeh
Position
MS in Nursing
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti Ave., Rasht
City
Rasht
Postal code
41469-39814
Phone
+98 13 1555 5056
Fax
Email
yeganeh@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Reza Yeganeh
Position
Ms in Nursing
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti Ave., Rasht
City
Rasht
Postal code
41469-39814
Phone
+98 13 1555 5056
Fax
Email
yeganeh@gums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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