Objective:The effect of Quran recitation on changes of consciousness level of adult comatose patients .
Study design: Randomized clinical trial. Study population: comatose patients admitted in intensive care unit.
Major inclusion criteria: patients with a diagnosis of traumatic brain injury; level of consciousness between 8 to 11; Age range 18 to 60 years . Major exclusion criteria: patient died or released before the seventh day; In case of reduce level of consciousness (less than 8). Sample Size: 30 patients, that randomly will be devided to 3 groups of 10 people (one intervention group and two control group ).
Intervention: after stabilization of hemodynamic symptoms are enrolled , The initial consciousness level will be measured .
In the intervention group , for 7 consecutive days and each day 15-minute , recorded tape of verses from the Surah Yasin with Mohammad Shhat Anwar voice , for patients will played via headphone .
Every day 5 minutes before and 10 minutes after each intervention, patients in the intervention group and the control group 1 (with headphones and without Quran recitation) and the control group 2 (without headphones and without Quran recitation), The Glasgow coma score scale (GCS)will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042221895N1
Registration date:2015-07-17, 1394/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-17, 1394/04/26
Registrant information
Name
Mohamad Hashem Abdi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5434 1501
Email address
mh.abdi@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Jahrom University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-12-06, 1394/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of Effect of Quran recitation pleasant on change of consciousness in comatose adults patient
Public title
Survey of Effect of Quran recitation pleasant on change of consciousness in comatose patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Admitted with a diagnosis of traumatic brain injury;Level of consciousness between 8 and 11; Aged between 18-60 years ;No history of hospitalization in the intensive care unit; No history of mental illness and depression;No history of ear disease and hearing loss history.
Exclusion criteria: Discharged before the seventh day; The patient died before the seventh day;In case of loss of consciousness (less than 8); Full consciousness of the patient before the seventh day;Transfer to another hospital center.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After preparing the list and assign a number to each of the samples using a draw will be divided into three groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences , Motahari Street , Jahrom Jahrom
City
Jahrom
Postal code
Approval date
2015-06-02, 1394/03/12
Ethics committee reference number
IR.JUMS.REC.1394.017
Health conditions studied
1
Description of health condition studied
head trauma
ICD-10 code
F07.2
ICD-10 code description
Postconcussional syndrome
Primary outcomes
1
Description
Increase the level of consciousness
Timepoint
5 minutes before and 10 minutes after each intervention
Method of measurement
Glasgow coma scor scale
Secondary outcomes
1
Description
Reduce the duration of hospital stay
Timepoint
After intervention in regular interval period
Method of measurement
Three day intervals
Intervention groups
1
Description
In the intervention group sound of the Quran via headphones will play.
Category
Other
2
Description
In control group 1: With headphones, but the sound of the Quran can not be played.
Category
Other
3
Description
In control group 2 :patients receive routine care, especially without any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Peymanieh Hospital
Full name of responsible person
Mohamad Hashem Abdi
Street address
Vali Asr street , jahad Square , Jahrom
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Jahrom University of Medical Sciences.
Full name of responsible person
Doctor Solhjo Vice Chancellor research of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences , Motahari Street , Jahrom
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Mohamad Hashem Abdi
Position
Nursing Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Paramedic , Motahari Street , Jahrom
City
Jahrom
Postal code
Phone
+98 71 5434 1501
Fax
+98 71 5434 1508
Email
mh.abdi@jums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohamad Hashem Abdi
Position
Nursing faculty Member
Other areas of specialty/work
Street address
School of Nursing and Paramedic , Motahari Street , Jahrom
City
Jahrom
Postal code
Phone
+98 71 5434 1501
Fax
Email
mh.abdi@jums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohamad Hashem Abdi
Position
Nursing Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Paramedic , Motahari Street , Jahrom
City
Jahrom
Postal code
Phone
+98 71543415014
Fax
Email
mh.abdi@jums.ac.irmohamadehsan92@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)