Injections are among the most frequently used medical procedures, with more than 12 billions injections administered each year world-wide. In spite of the wide use of the procedure, pain associated with injection remains an unsolved problem of the contemporary medical practice. Reducing patients’ pain is important for all nurses for many reasons. Unnecessary pain can damage the nurse—patient relationship and may also lead to dangerous syncopal attacks.
The aim of this study is to compare of effects of two muscular injection methods on site-pain intensity of injection in patients who refer to injections ward of Kamkar-Arabnia hospital, Qom, Iran, in 2010.
In this work, 75 women with ages from 16-60 years who have penicillin injection intramuscularly in a health centre will be studied. The samples are chosen randomly divided into three groups: the first group will receive intramuscular injection with the application of the blunt pins, the second group will receive local cold therapy and the third group (the control group) will receive routine care. Pain will be tested with the visual analogue scale on a 0 (no pain)-10 (maximum pain) scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011012560N4
Registration date:2010-12-02, 1389/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-02, 1389/09/11
Registrant information
Name
Mohammad reza Yeganehkhah
Name of organization / entity
Qom University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6630 4368
Email address
yeganehkhah@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences and Health Services
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effects of two muscular injection methods on site-pain intensity of injection
Public title
Comparing effects of two muscular injection methods on site-pain intensity of injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1) Women aged 18-80 years. 2) Having order to receive Penicillin 6.3.3 as a IM injection. 3) Having no sensitivity to Penicillin. 4) Oriented to person/ place/ time/ situation. 5) Ability of patient to assess the pain with visual analogue scale. 6) Ability of patient to looking and listening. Exclusive criteria: 1) Having pain in the injection site. 2) BMI less than18.5 and more than 30. 3) Having wound or scar in the injection site. 4) Absence of collaboration.
Age
From 16 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The sample size of the study was calculated with power of 80% and significance level of 5% according with the result of previous studies.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences and Health Services
Street address
Qom University of Medical Sciences and Health Services, Saheli st., Qom., Iran.
City
Qom
Postal code
37185
Approval date
2010-10-21, 1389/07/29
Ethics committee reference number
ت/12050/34
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain
Timepoint
Before and after intramuscular injection
Method of measurement
Visual Analogue pain Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
(1) In the first group, injections will perform with a plastic device, that consists of an oval disk (54 mm×40 mm) that supports multiple blunt pins (9 pins per cm2). In the middle of the oval support there is a hole of 5 mm of diameter.
The use of the device is the following: first it is put on the skin at the injection site, then the injection needle is inserted in the hole of the device until it reaches the skin, without penetrating it; the device is then gently, but firmly, pressed onto the skin immediately prior and during the penetration of the injection needle into the skin. The device does not interfere with the needle penetration or with the drug delivery and there is no contact between the device and the injection needle.
Category
Other
2
Description
(3) In the control group, a standard injection is give with no further intervention as it is routine in most hospitals.
Category
N/A
3
Description
(2) In the second group(cold therapy), the subjects will inform that a 2—3 cm piece of ice would be placed on the injection site on the gluteal muscle for 30 s prior to injection.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamkar-Arabnia hospital
Full name of responsible person
Street address
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences and Health Services
Full name of responsible person
Ali Salimi
Street address
Saheli st.
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences and Health Services
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
Qom University of Medical Sciences and Health Services