Objective: To determine the effect of Quran voice on the level of consciousness in anesthetized patients that admitted to the intensive care unit/
Study: randomized, double-blind, placebo-uncontrolled, single-center/
a)
Study population: anesthetized patients that hospitalized in the intensive care unit of the complex of martyr modarres hospital in saveh city/
Inclusion criteria:
1. level of consciousness from 3 to 7 on the criteria of the Glasgow coma scale, for 48 hours -
2. Age of 18 to 65 years -
3. No drastic change in shape of face, after severe trauma -
4. Islamic Belief/
Exclusion criteria:
1. Before the tenth day of discharge from the intensive care unit -
2. After 24 hours of surgery -
3. Fatal/
Sample size: 66/
B) intervention study: The effect of Quran voice on the level of consciousness in anesthetized patients that admitted to the intensive care unit/
C) Study time: from the beginning of March 2017 to the end of April Year 2017/
D) The primary outcome: a complete lack of awareness (consciousness between 3 to 7)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122331522N1
Registration date:2017-01-18, 1395/10/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Vahid Naseri Salahshour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
v.naserisalahshour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Quran voice on the level of consciousness in comatose patients in Intensive Care Unit
Public title
The effect of Quran sound on consciousness in comatose patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
- level of consciousness from 3 to 7 on the criteria of the Glasgow coma scale, for 48 hours.
- Age of 18 to 65 years
- No history of hospitalization in ICU
- No drastic change in shape of face, after severe trauma
- The absence of underlying disease diagnosed as tuberculosis, cancer and hepatitis
- Islamic beliefs/
Exclusion criteria:
- Before the tenth day of discharge from the intensive care unit
- Transfer of patients to other health centers
- After 24 hours of surgery
- Reluctance of patients to continue research fellows
- Fatal
Age
From 17 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples using dice randomly placed in two groups (Intervention and Control)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences and Health Services
Street address
Tehran Province, Tehran, District 6, Pour Sina St
City
Tehran
Postal code
1419733171
Approval date
2016-11-15, 1395/08/25
Ethics committee reference number
IR.TUMS.FNM.REC.13951042
Health conditions studied
1
Description of health condition studied
Coma (unconsciousness)
ICD-10 code
R40.2
ICD-10 code description
Coma, unspecified
Primary outcomes
1
Description
level of consciousness
Timepoint
Before intervention, three days after the start of intervention (third day), four days after the first assessment (seventh day), three days after the second assessment (tenth day)
Method of measurement
glascow coma scale
Secondary outcomes
1
Description
Heart beat
Timepoint
During the intervention, immediately after intervention
Method of measurement
Beat per minute
2
Description
ECG changes
Timepoint
During the intervention, immediately after intervention
Method of measurement
Electrocardiogram
Intervention groups
1
Description
Control group: daily care depending on the needs of patients in the control group (similar with intervention group) is executed and the samples from both groups were homogeneous as possible, are compared to each.
Category
Other
2
Description
Intervention Group: The intervention group patients once daily for 20 minutes at a time for up to ten days Listen to Quran sound (ostad shahryar)that played through the headphones.
Audio player and headphones produced by China and manufactured by Samsung company
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The ICU of Hospital complex of modarres martyr, Saveh University of Medical Science/
Full name of responsible person
Vahid Naseri Salahshour, MSc of Nursing Education in Medical Surgical Field
Street address
saveh, shahid beheshti blv, mehr st, avisa residential complex, fifth floor, the eighteenth unit
City
Saveh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Nursing and Midwifery School of Tehran University of Medical Science
Full name of responsible person
Dr. Ziba Taghizadeh (Assistant Professor and PhD in Reproductive Health), Vice Chancellor for resear
Street address
Tehran, Nosrat St, Tohid Sq, School of Nursing and Midwifery
City
Tehran
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 Nursing and Midwifery School of Tehran University of Medical Science
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
Arak University of Medical Science
Full name of responsible person
vahid naseri salahshour
Position
MSc of Nursing Education in Medical Surgical Field
Other areas of specialty/work
Street address
saveh, shahid beheshti blv, mehs st, avisa residential complex, ffth floor, the eighteenth unit