The effect of implementation of a pain management algorithm on the level of consciousness and pain intensity in patients with loss of consciousness hospitalized in intensive care unit
Determining the effect of pain management algorithm on the level of consciousness and pain intensity in patients with decreased level of consciousness in hospitalized patients
Design
Patients are selected by non-random sampling method and according to entry criteria. Then, using random allocation with inertial blocks, pain management and control group will be implemented in two groups.
Settings and conduct
The method of this study is to measure the intensity of pain in patients with decreased level of consciouness between 5-8 based on the glascow scale and based on the pain management algorithm and the site of this study is the intensive care unit of Khatam Hospital in Zahedan.
Participants/Inclusion and exclusion criteria
Criteria For entering the study;
1- The patient's level of consciouness is 5 to 8 based on Glascow coma's scale
2- The patients aged 18 to 65 years old
3- Initiation of sedative infusion
Non-entry criteria;
1-The patient with plegia
2- The patient with neuromuscular and sensory-motor disorders
3- The patients with chronic pain in other parts of the body, such as Migraine and back pain
Intervention groups
In the intervention group, the pain management algorithm will be implemented in three shifts per day. Pain severity scores are measured and recorded 3 times by the Behavioral Pain Scale (BPS) 3 times before the algorithm is executed (in each shift one time the algorithm is executed) and 3 times after it is completed.
the control group, routine measures are undertaken to relieve, evaluate and control the pain.
Main outcome variables
level of consciousness, pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170703034873N2
Registration date:2018-03-14, 1396/12/23
Registration timing:registered_while_recruiting
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
fariba Yaghoubinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 0059
Email address
yaghoubinia@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementation of a pain management algorithm on the level of consciousness and pain intensity in patients with loss of consciousness hospitalized in intensive care unit
Public title
The effect of implementation of a pain management algorithm on the level of consciousness and pain intensity in patients with loss of consciousness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patients aged 18 to 65 years old
The patient's level of consciouness is 5 to 8 based on Glascow coma's scale
Initiation of sedative infusion
Exclusion criteria:
The patient with plegia
Musculoskeletal, sensory and motor disorders
The patient has chronic pain in other parts of the body, such as migraine and back pain
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be convenience sampling method on the basis of entry criteria and Patients were randomly assigned to two intervention and control groups based on permutation block method.
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 of Zahedan University of Medical Sciences
Street address
Pardis administrative Complex of Zahedan University of Medical Sciences, Docter Hesabi Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.ZAUMS.REC.1396.357
Health conditions studied
1
Description of health condition studied
Patients with decreased level of consciousness
ICD-10 code
R29
ICD-10 code description
Other symptoms and signs involving the nervous and musculoskeletal systems
Primary outcomes
1
Description
pain intensity
Timepoint
Before The intervention and thirty minute after the intervention
Method of measurement
Behavioral Pain Scale
Secondary outcomes
1
Description
level of consciousness
Timepoint
Before and After intervention
Method of measurement
Glasgow coma Scale
Intervention groups
1
Description
" The intervention group":The pain management algorithm will be implemented in three shifts a day. Patients' pain intensity is recorded using the behavioral scale of BPS pain measurement before and after intervention. The level of consciousness is recorded using the GCS scale before and after the intervention. If pain reduces or increases, the relief measures decrease or increase.
Category
Other
2
Description
"The control group": routine measures are undertaken to relieve, evaluate and control the pain.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Al-Anbia hospital
Full name of responsible person
Fariba Yaghoubinia
Street address
School of Nursing and Midwifery, Mashaheir Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
yaghoubinia@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Doctor NoorMohamad Bakhshani
Street address
Pardis administrative Complex of Zahedan University of Medical Sciences, Doctor Hesabi square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Dehghani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mashaheir square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
7619854444
Phone
+98 34 3121 7233
Email
dehghani460@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghoubinia
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mashaheir Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
yaghoubinia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghoubiniai
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mashaheir Square, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
yaghoubinia@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD