Objectives: This study has done based on defining the impact of changing needle, in order to reduce pain on intramuscular injection.
Design: This study through crossing and randomized method.
Setting and conduct: The researcher extracted 5 cc of this medicine by syringe needle as code No.21, and after forcing out air through syringe needle, he changed the needle, and put the labeled code"1"(injection with needle changed or" interfering Group"), the repeated this process, but not change its needle, and Labeled it code"2" (injection without needle changed or" control Group") after that, in following he defined which code (1or 2) is used for the fist injection by Heads or Tails way. Therefore, method of injection and syringe code of second injection was contrary with the first one. Duration of second injection was 20 min after the first one.
Participants including major eligibility criteria: We chose 70 female patients with intramuscular injection of Metucarbamul medicine and the age should be over 18 and under 58 years.
Intervention: needle changing
Main outcome measures: severity of pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062313749N1
Registration date:2016-12-23, 1395/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-23, 1395/10/03
Registrant information
Name
Amene Manavy shad
Name of organization / entity
Arvand International University
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 3515
Email address
ami.manavy@yahoo.com
Recruitment status
Recruitment complete
Funding source
Arvand International University - Ahvaz Jundishapur University of Medical Science , Ahvaz, Iran
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of needle changing on severity of pain induced by intramuscular injection in female patients
Public title
The effect of needle changing by intramuscular injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age should be over 18 and under 58 years; Holding the permission of intramuscular injection of Metocarbamul medicine; Not committing intramuscular injection within the last week; Having body mass of 19-25; Being conscious of the ill person; Non using any pain killer medicine prior to injection
Exclusion critwria: study existence of blue-dark, reddish marks and inflammation and wound in the place of injection; Having record of diabetic.
Age
From 18 years old to 58 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
1
Registry name
_
Secondary trial Id
_
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Science
Street address
Ahvaz Jundishapur University of Medical Science ,Golestan , Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
ajams/REC/1392/112
Health conditions studied
1
Description of health condition studied
severity of pain
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
severity of pain
Timepoint
After finishing injection,measuring patent pain
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: The researcher extracted 5 cc of this medicine by syringe needle as code No.21, and after forcing out air through syringe needle, he changed the needle, and put the labeled code "1"(injection with needle changed). Interfering Group.
Category
Treatment - Other
2
Description
Intervention1: The researcher extracted 5 cc of this medicine by syringe needle as code No.21, and after forcing out air through syringe needle, but not changed the needle, and put the labeled code "2"(injection without needle changed).Control Group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghan Hospital
Full name of responsible person
leila Fakharzadeh
Street address
No8,Asatid Falat Bulding, In front of Abadan international airport, Abadan, Khuzestan,Iran
City
Abadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Science Vice chancellor for research Arvand International University
Full name of responsible person
Bahram Abdali
Street address
Arvand international university, In front of Abadan international airport
City
Abadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Science Vice chancellor for research Arvand International University
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Medical Science Vice chancellor for research Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Mostafa feghihi
Street address
Ahvaz Jundishapur University of Medical Science ,Golestan Ahvaz, Iranch
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Science Vice chancellor for research Ahvaz Jundishapur University of Medical Science
Proportion provided by this source
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
Arvad International University
Full name of responsible person
Bahram Abdali
Position
Medical Science Vice chancellor for research Arvand International University
Other areas of specialty/work
Street address
Arvand international univercity, In front of Abadan international airport
City
Abadan
Postal code
Phone
+98 63 1333 5364
Fax
Email
bahram_abdali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arvand International University
Full name of responsible person
leila Fakharzadeh
Position
M.A Nursing
Other areas of specialty/work
Street address
No 8, Asatid Flalat Bulding, In front of Abadan international air port, Abadan, Khuzestan , Iran
City
Abadan
Postal code
Phone
+98 63 1333 7857
Fax
Email
fakharzadehl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arvand International University
Full name of responsible person
Amene Manavy Shad
Position
Nursing graduate student
Other areas of specialty/work
Street address
No 742,2 nd, Golestsn, Bame Tehran building ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2213 3515
Fax
Email
ami.manavy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)