Objectives:Traumatic Brain Injuries is one of the major causes of death and disability around the world. Recently to improve the results of the coma, coma stimulation techniques is suggested. Accordingly, the aim of this study was to compare the effect of hearing a familiar voice and the Azan sound in level of Consciousness and Hemodynamic Parameters .
Design: this study is a clinical trial with pre and post test design.
Setting and conduct: 51 Patients with coma randomly divided in 3 groups: Familiar sound group (n=18), Azan group (n=18) and Control group (n=15).
Inclusion criteria for this study included:
Comatose traumatic patients; Muslim patients; Ages range from 68-14 years; Levels of consciousness 8 and less than 8
Exclusion criteria included:
patient died before day 14 in both groups; Swelling of both eyelids; Changes in the patient's condition so that the possibility of intervention , such as sending a patient away to another hospital, cardiac arrest
Intervention: Familiar sound group, 14 days, 2 time a day, afternoon and evening prayers, the voice of one of his relatives received. Azan group received the same way azan sound. Before and after each intervention level of Consciousness and Hemodynamic Parameters were recorded. level of Consciousness and Hemodynamic Parameters was recorded in the same way in control group, twice a day, without any intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081418794N1
Registration date:2015-02-23, 1393/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Fatemeh Mogaddam
Name of organization / entity
Zanjan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 24 3575 3185
Email address
s.faghihzadeh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2013-06-24, 1392/04/03
Expected recruitment end date
2013-12-24, 1392/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Auditory stimulation by family voices and recitation of prayers on consciousness level and hemodynamic changes of comatose patients
Public title
Auditory stimulation in comatose patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for this study included:
Comatose traumatic patients; Muslim patients; Ages range from 68-14 years; Levels of consciousness 8 and less than 8; No fracture and surgery for temporal lobe; The lack of swelling of both eyelids; Absence of severe mental illness; Absence of Fracture four limbs; Family consent for participation in the study; The absence of hearing loss.
Exclusion criteria included:
patient died before day 14 in both groups; Swelling of both eyelids; Changes in the patient's condition so that the possibility of intervention , such as sending a patient away to another hospital, cardiac arrest.
Age
From 14 years old to 68 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
51
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
Ethics Committee, Zanjan University of Medical Science
Street address
Zanjan University of Medical Sciences, Beginning of the Islamic Republic of Iran, Azadi Square, Zanjan
City
Zanjan
Postal code
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
zums.rec.1392.42
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
SO6.0, SO6
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Level of Consciousness
Timepoint
pre and post intervention
Method of measurement
GCS Scale
2
Description
Hemodynamic Status
Timepoint
pre and post intervention
Method of measurement
Monitoring sistem and Termometer
Secondary outcomes
empty
Intervention groups
1
Description
Patient familiar voice was recorded with mp3 by Mark Marshall. This sound contains was introduction to a patient, slight accident occurred and reassuring messages. Sounds were delivered through headphones to listen to the patient. Before using for the patient controlled louder volume by researcher to patient does not hurt. Sound familiar twice a day for two weeks, in time for afternoon prayer and the sunset in the patients was born into group.Sounds duration of about 3 to 5 minutes. Before and after intervention in group consciousness level and hemodynamic variables were recorded.
Category
Other
2
Description
The sound of the call to prayer of the muezzin's voice was born. The call duration is approximately 4 minutes that 14 days this sound like a familiar voice, twice daily at noon and evening prayer for the patient by headphone. Before and after the intervention of consciousness and hemodynamic variables were recorded.
Category
Other
3
Description
The control group did not receive any intervention by the researcher.It's just routine hearing voices.In this group, twice daily for 14 days, Level of consciousness and hemodynamics were recorded.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Fatemeh Mogaddam
Street address
Ayatollah Mousavi Hospital, Road Gavazng, Zanjan
City
Zanjan
2
Recruitment center
Name of recruitment center
Emdadi Hospital Abhar
Full name of responsible person
Street address
City
Abhar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Sciences Vice Chancellor for Research, Zanjan University of Medical Science
Full name of responsible person
Sograt Faghihzadeh
Street address
Zanjan University of Medical Sciences, Beginning of the Islamic Republic of Iran, Azadi Square, Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Sciences Vice Chancellor for Research, Zanjan 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
Zanjan University of Medical Science
Full name of responsible person
Fatemeh Mogadam
Position
Master
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Beginning of the Islamic Republic of Iran, Azadi Square, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3575 3185
Fax
Email
Fateme.mogadam@gmail.com; payami@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Science
Full name of responsible person
Mitra Payami Busari
Position
Asistant
Other areas of specialty/work
Street address
School of Nursing, Parvin Etesami S, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3377 0909
Fax
Email
Fateme.mogadam124@gmail.com; payami@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)