(1) Objectives: to compare the pain severity after applying acupressure on UB32 or LI4 acupoints and the routine intramuscular injections, (2) Design: A three group, non blind clinical trial will be conducted on 90 patients that equally assigned in the three study groups (30 ones in each group). The subjects will be assigned in the study groups trough randomized block method. (3) Setting and conduct: The study setting is the nursing department of Kashan’s central emergency department which is the main outpatient department in the center of kashan city, (4) Participants: The women who refer for intramuscular injections of penicillin. The main inclusion criteria are: age between 18-60 years old, having a muscular injection of Penicillin, and lack of any lesion in the injection site and in pressure points. (5) Intervention: Applying acupressure in UB32 or LI4 acupoints, before injection (6) Main outcome measures: The severity of perceived pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901223618N2
Registration date:2015-12-30, 1394/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Mohsen Adib-Hajbaghery
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36155540021
Email address
adibhajbagheri_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
َA clinical trial to compare the effect of acupressure on UB32 and LI4 acupoints on pain of intramuscular injection in women
Public title
Effect of acupressure on pain of intramuscular injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age between 18-60 years old; 2) Having a muscular injection of Penicillin; 3) Lack of any lesion (i.e. wound, edema, fracture) in the places of injection and acupressure; 4) Having no trauma or accident; 5) Having no known mental disorder and acute cardiac problem; 6) Being fully conscious; 7) Signing an informed consent to participate in the study.
Exclusion criteria:
1) a patient decision to withdraw from the study.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blocked randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Kashan University of Medical Sciences
Street address
Research deputy, Kashan University of Medical Sciences, 3rd Km of Ravand road, Kashan, Iran
City
Kashan
Postal code
8715988141
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.KAUMS.REC.1394.75
Health conditions studied
1
Description of health condition studied
Pain of intramuscular injection
ICD-10 code
R00-R09
ICD-10 code description
Symptoms and signs involving the circulatory and respiratory systems
Primary outcomes
1
Description
Pain intensity
Timepoint
Immediatly after injection
Method of measurement
A Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Acupressure on LI4
Category
Treatment - Other
2
Description
Intervention group 2: Acupressure on UB32
Category
Treatment - Other
3
Description
Control group: No acupressure will be done
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan's Central Emergency Department
Full name of responsible person
Mr. Faiazi
Street address
Kashan's Central Emergency Department, Baba Afzal avenu, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Research deputy, Kashan University of Medical Sciences, 3rd Km of Ravand road, Kashan, Iran
City
Kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Adib-Hajbaghery
Position
Faculty member
Other areas of specialty/work
Street address
Faculty of Nursing, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
adib1344@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Adib-Hajbaghery
Position
Professor
Other areas of specialty/work
Street address
Faculty of Nursing, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 31555400215
Fax
Email
adib1344@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Raddadi
Full name of responsible person
Yasaman
Position
Kashan University of Medical Sciences
Other areas of specialty/work
Street address
Nursing student
City
Faculty of Nursing, Kashan University of Medical Sciences
Postal code
Isfahan
Phone
00
Fax
Email
yasamanrd@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)