The aim of this randomized clinical trial is to determine the effect of cold compress on pain of intramuscular injection of penicillin G benzathine in adult males.
Inclusion criteria: age 15-50 years old; penicillin G benzathine prescription by a physician; educational level of at least secondary school; no problem at injection site; willingness to participate in the study.
Exclusion criteria: presence of any kind of pain before the injection; unwillingness to participate in the study; clogging of needles during injection; sensory and motor disorders; diabetes mellitus; severe pain for another reason; presence of communication problems.
In this study 100 patients in the clinic of Imam Khomeini hospital of Esferayen whom were prescribed penicillin G benzathine were randomly allocated into intervention and control groups. Randomization will be done using sealed envelopes. The intervention group received a cold compress with a 2-8 °C on the dorsogluteal muscle for 5 minutes before intramuscular injection. Injection for the control group will be done in a routine method. The researcher will administer the drug for both groups. The severity of pain will be measured using the Visual Analog Scale during, immediately and 5 minutes after injection (Scale VAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091229797N1
Registration date:2016-12-22, 1395/10/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-22, 1395/10/02
Registrant information
Name
Hamid Zohrabi
Name of organization / entity
Esfarāyen University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 8976
Email address
zohrabi.h@esfrums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Esfarayen University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cold compress on the pain of intramuscular injection of penicillin G benzathine in adult males
Public title
Effect of cold compress on intramuscular injection pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 15-50 years old; penicillin G benzathine prescription by a physician; educational level of at least secondary school; no problem at injection site; willingness to participate in the study.
Exclusion criteria: presence of any kind of pain before the injection; unwillingness to participate in the study; clogging of needles during injection; sensory and motor disorders; diabetes mellitus; severe pain for another reason; presence of communication problems.
Age
From 15 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfarayen University of Medical Sciences
Street address
Imam Reza street،
City
Esfarāyen،
Postal code
9661856188
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR- ESFARAYENUMS.REC.1394.12
Health conditions studied
1
Description of health condition studied
Intramuscular injection
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Pain severity
Timepoint
Three times: during injection, immediately after the injection and 5 minutes after injection.
Method of measurement
VAS Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control Group: In this group, the injection will be done according to routine method and pain severity will be measured during, immediately and 5 minutes after injection.
Category
Treatment - Other
2
Description
Intervention group: In this group participants will receive a 5 minute cold compress with an ice pack on dorsogluteal muscle before the injection. The severity of pain will be measured during, immediately, and 5 minutes after the injection.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfarāyen’s Imam Khomeini (RA) Hospital
Full name of responsible person
Hamid Zohrabi
Street address
Imam Reza Ave
City
Esfarāyen
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Esfarayen University of Medical Sciences
Full name of responsible person
Eshagh Ildarabadi
Street address
Imam Reza street
City
Esfarayen
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 of Esfarayen 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
Esfarāyen University of Medical Sciences
Full name of responsible person
Mahmod Marhamati
Position
MSc Medical-surgical nursing
Other areas of specialty/work
Street address
Imam Reza street،
City
Esfarāyen،
Postal code
9661876981
Phone
+98 58 3722 3505
Fax
Email
marhamati.m@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfarāyen University of Medical Sciences
Full name of responsible person
Hamid Zohrabi
Position
Nursing Student
Other areas of specialty/work
Street address
Imam Reza street،
City
Esfarāyen،
Postal code
9661876981
Phone
+98 58 3723 8976
Fax
Email
zohrabi.h@esfrums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfarāyen University of Medical Sciences
Full name of responsible person
Hamid Zohrabi
Position
Nursing Student
Other areas of specialty/work
Street address
Imam Reza street،
City
Esfarayen،
Postal code
9661876981
Phone
Fax
Email
zohrabi.h@esfrums.ac.ir; h.zohrabi73@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)