This research is a randomized clinical trial with the aim of determining the effect of organized auditory stimulation with familiar sound to the pain and physiological indices of coma patients tha was conducted in ICU wards of Shahid Kamiyab Hospital in 2017 in 40 patients with intubation who had the criteria for entering the study and were selected easily and conveniently and randomly divided into two groups of 20 (Control and test) were performed. In the experimental group, auditory stimulation with familiar voice was performed for 3 consecutive days and 15 minutes each day by headphones and in the intervention group without auditory stimulation, pain was recorded before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072035196N1
Registration date:2017-09-17, 1396/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-17, 1396/06/26
Registrant information
Name
Amir Khojeh
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3452 1063
Email address
a.khojeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Research Deputy of Gonabad University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Organized Auditory Stimulation on Pain Intensity and Physiologic Indices in Comatose Patients in Intensive Care Unit
Public title
The effect of organized auditory stimulation with familiar sounds on pain and physiological indices in Comatose Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 50 years old; Head trauma with a level of consciousness between 5 to 8 based on Glasgow's scale; Pain with at least 5 scores based on measurement with Behavior Pain Scale; Artificial airway (tracheal tube or tracheostomy); Duration of coma up to 48 hours at the start of the survey; Absence of hearing impairment, neuromuscular and sensory-motor disorders; Non-breakage or paralysis of all organs Exclusion criteria: Brain death; Death or discharge from the Intensive Care Unit; Extubation of the patient; Increasing the dose of sedative and anesthetic drugs during the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Gonabad University of Medical Sciences
Street address
Next to the Asian Road, Educational and Research Deputy of Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691793718
Approval date
2017-03-14, 1395/12/24
Ethics committee reference number
IR.GMU.REC.1395.120
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Generalized pain NOS
Primary outcomes
1
Description
Pain
Timepoint
Before and after intervention
Method of measurement
Behavior Pain Scale
2
Description
Blood pressure
Timepoint
Before, during and after the intervention
Method of measurement
Monitoring device
3
Description
Pulse
Timepoint
Before, during and after the intervention
Method of measurement
Monitoring device
4
Description
Body temperature
Timepoint
Before, during and after the intervention
Method of measurement
Monitoring device
5
Description
Arterial oxygen saturation
Timepoint
Before, during and after the intervention
Method of measurement
Monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intraocular stimulation of a person with familiar voice, 3 consecutive days and 15 minutes each day with headphones.
Category
Treatment - Other
2
Description
Control group: Putting the headphones on the ears of the control group (no audible stimulation)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab Hospital
Full name of responsible person
Amir Khojeh Student of master degree in critical care nursing
Street address
Street of Fadaiyan Islam, Nakhrisi Crossroad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Pour Vice chancellor for research
Street address
Next to the Asian Road
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Amir Khojeh
Position
Student of master degree in critical care nursing / Nurse
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
Email
a.khojeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Moosa Sajjadi
Position
Ph.D. in Nursing
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
Email
sajjadi1975@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amir Khojeh
Position
Student of master degree in critical care nursing / Nurse
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
Email
a.khojeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)