Protocol summary

Summary
The purpose of study to determine the effect of pain monitoring developed program in patients with decreased level of consciousness on the performance of nurses in the diagnosis and management of pain in the intensive care unit.Inclusion criteria: GCS score of 5 to 8;age 18 to 65 years. Exclusion criteria included: the endotracheal tube extubation; substantial drop in level of consciousness. Study population: Imam Reza and Ghaem Hospital ICU admitted patients .samples size: 60 patients. Intervention: Learning Non-verbal pain scale and pain Management Protocol for a month. primary outcome: increased performance of nurses in control and pain diagnosis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062526113N1
Registration date: 2016-08-04, 1395/05/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Majid Akhond
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3661 5128
Email address
akhondm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pain monitoring developed program in patients with decreased level of consciousness on the performance of nurses in the diagnosis and management of pain in the intensive care unit
Public title
The effect of pain monitoring developed program in patients with decreased level of consciousness on the performance of nurses in the diagnosis and management of pain in the intensive care unit
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: GCS score of 5 to 8;Endotracheal tube or tracheostomy; lack of treatment of muscle relaxants and painkillers ; the age 18 to 65 years. Exclusion criteria included: the endotracheal tube extubation; substantial drop in level of consciousness; septicemia; hypovolumia ; tachyarrhythmia.
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: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Qureshi Building ,TaghiAbad,Mashhad
City
Mashhad
Postal code
Approval date
2016-06-19, 1395/03/30
Ethics committee reference number
IR.MUMS.REC.1395.159

Health conditions studied

1

Description of health condition studied
Loss of consciousness
ICD-10 code
F13
ICD-10 code description
Mental and behavioural disorders due to use of sedatives or hypnotics

Primary outcomes

1

Description
pain monitoring
Timepoint
one month
Method of measurement
builting researcher observentional checklist

Secondary outcomes

1

Description
Muscle relaxant drugs
Timepoint
one month
Method of measurement
pain monitoring protocol

2

Description
age
Timepoint
one month
Method of measurement
pain monitoring protocol

Intervention groups

1

Description
Learning Non-verbal pain scale and pain management Protocol for a month .
Category
Other

2

Description
In the control group will be not given additional explanation about pain assessment and pain monitoring developed program.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Reza emam hospital
Full name of responsible person
Dr. froutan razie
Street address
Reza emam hospital -taghiabad-mashhad
City
Mashhad

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Froutan, Razie
Street address
Ghaem Hospital -taghiabad-mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Froutan, Razie
Street address
Building ghoreshi-university avenue-mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Dr.Froutan, Razie
Position
Nursing PhD
Other areas of specialty/work
Street address
Building jorjani- taghiabad-mashhad
City
Mashhad
Postal code
Phone
+51 38591511
Fax
Email
froutanr@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Dr Froutan, Razie
Position
Nursing PhD
Other areas of specialty/work
Street address
Building jorjani-taghiabad-mashhad
City
Mashhad
Postal code
Phone
+51 38591511
Fax
Email
froutanr@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Majid Akhond
Position
Critical Care Nursing postgraduate
Other areas of specialty/work
Street address
ICU-A-Emam Reza Hospital -Taghiabad-Mashhad
City
Mashhad
Postal code
Phone
+51 8023710
Fax
Email
akhondm1@mums.ac.irmajid6129@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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