Protocol summary

Summary
General objective: comparing psychometric properties of two pain assessment scales (BPS, NVPS) in non-verbal patients under mechanical ventilation. Design: Clinical trial of type methodological. Inclusion criteria include the following: patients under ventilation; with endotracheal tube for more than 24 hours, able to listen and respond with shaking the head, eyebrows or eyes; the level of agitation and sedation between +1 and -3, according to Richmond Agitation Sedation Scale (RASS). Exclusion criteria include: patients with quadriplegia; neuromuscular dysfunction and extensive injury in face and arms. Setting and conduct: This study is done on 50 to 60 patients under mechanical ventilation, hospitalized in the adults’ intensive care unit of Alavi, Emam, and Fatemi hospitals of the Ardabil University of Medical Sciences. Before conducting the study, the procedure will be explained to the first degree relatives, and in case they agree to participate, the investigation will be carried out. In this study, two tools, "BPS" and "NVPS", will be used. Each tool will be filled independently by two raters and simultaneously carried out on a patient. Intervention: The behavior of each patient will be seen 15 minutes before, during, and 15 minutes after both nociceptive (turning and oral suctioning ) and non-nociceptive (eye care by normal saline) procedures. Main outcome measures (variables): The patient’s pain are recorded according to; two Behavioral pain scales. Then at the end of each stage the patient will be asked whether they feel pain or not. The patient’s physiological symptoms are recorded by monitoring vital signs in all the six steps. After gathering enough samples, the tools will be compared and their psychometric properties will be measured

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062322881N1
Registration date: 2015-10-28, 1394/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-28, 1394/08/06
Registrant information
Name
Mehdi Heidarzadeh
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 8005
Email address
m.heidarzadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences; Doctor Shahram HabibzadeAddress: University Street, Janbazan Square, Ardabil, IranPostcode:5618953141, Telephone (Landline): 00984533522083, Email: s.habibzadeh@arums.ac.ir
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing psychometric properties of “behavioral pain scale” and “Non-verbal Pain Scale” in mechanically ventilated patients admitted to the intensive care unit
Public title
Comparing psychometric properties of two pain assessment scales
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients over 18 years old; Patients in intensive care units; patients on ventilators with endotracheal tube for more than 24 hours; able to listen and respond with shaking the head; eyebrows or eyes; the level of agitation and sedation between +1 and -3; according to Richmond Agitation Sedation Scale (RASS). Exclusion criteria: Patients with quadriplegia; those receiving muscular blocking agents or those with muscular dysfunction; Patients with Extensive injury in facial and arms; Patients with Drug addiction.
Age
From 18 years old
Gender
Both
Phase
2-3
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
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee Of Ardabil University Of Medical Science
Street address
Ardabil University Of Medical Science, University Street, Janbazan Square, Ardabil, Iran
City
Ardabil
Postal code
5618953141
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
IR.ARUMS.1394.1

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified

Primary outcomes

1

Description
pain
Timepoint
15 minutes before non-nociceptive procedure, during non-nociceptive procedure, and 15 minutes after non-nociceptive procedure
Method of measurement
Two behavioural pain scales, BPS, NVPS

2

Description
pain
Timepoint
15 minutes before nociceptive procedure, during nociceptive procedure and 15 minutes after nociceptive procedure
Method of measurement
Two behavioural pain scales, BPS, NVPS

Secondary outcomes

1

Description
physiological dimensions(Vital signs)
Timepoint
15 minutes before non-nociceptive procedure, during non-nociceptive procedure, and 15 minutes after non-nociceptive procedure
Method of measurement
Monitoring vital signs

2

Description
physiological dimensions(Vital signs)
Timepoint
15 minutes before nociceptive procedure, during nociceptive procedure and 15 minutes after nociceptive procedure
Method of measurement
Monitoring vital signs

Intervention groups

1

Description
During the non-nociceptive procedure will be washed the patient's eyes with gauze soaked in normal saline for a minute at 9 am and 6 pm. And during nociceptive procedure are given turning for a minute at 9 am and 6 pm.
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
Hoda Chokalayi
Street address
Imam Khomeini street, Ardabil, Iran
City
Ardabil

2

Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Dr. Mehdi Heidarzadeh
Street address
Martyr Moadi Street, Moghaddas Ardabili Street, Ardabil, Iran
City
Ardabil

3

Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Hoda Chokalayi
Street address
Ghagor jedi Ardabili Street, Ardabil, Iran
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Doctor Shahram Habibzade
Street address
University Street, Janbazan Square, Ardabil, Iran
City
Ardabil
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, Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Hoda chokalayi
Position
M.S student
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Saadi Street, highway Shohada, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 45 3372 6085
Fax
Email
B.chokalaee@arums.ac.ir; yaminfaresw@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehdi Heidarzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Saadi Street,Highway Shohada, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 45 3372 6085
Fax
Email
m.heidarzadeh@arums.ac.ir; m.mahda@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehdi Heidarzadeh
Position
Faculty member; PhD
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Saadi Street, highway Shohada, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 45 3372 8004
Fax
Email
m.heidarzadeh@arums.ac.ir ; m.mahda@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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