Comparison of dorsogluteal local pressure and Hugo's point massage with ice on pain sevirity due to intramuscular injection
Design
Clinical trial with control group, with parallel groups, with blinded group
Settings and conduct
The study population consisted of women who referred to the injection unit of Allameh Behlul Hospital in Gonabad.women who has inclusion criteria, after Explain the aims of the study and obtain informed consent, will be divided into intervention and control group randomly and based on the designated blocks. The conditions in the intervention and control groups will be the same. In intervention group 1, local pressure and in intervention group 2, Hugo's point massage will be done. In control group, injection is performed as usual
Participants/Inclusion and exclusion criteria
1.Informed consent to participate in the research.
2. Lack of stiffness, tenderness, and lesion at the injection site according to the patient's report.
3. No severe illness and pain duo to disease according to the patient's report.
4. No injection in that area a week ago according to the patient's report.
5. No pain before intramuscular injection.
6. Age between 18 and 50.
7. do not recive opioid and non-opioid painkiller in 2 hours before injection.
8. Don't be pregnant.
Intervention groups
For intervention group 1, a local pressure with thumb to the injection site applied until the patient feels pain for 10 seconds, then inject immediately.
For intervention group 2, Hugo's point massage of right hand with ice wrapped in plastic glove and One layer cotton cloth was done Clockwise for 3 minutes, with soft and continuous pressure of 3 kg / m2, then massage is stopped for 30 seconds, and after that this intervention will be repeated twice.
In control group, injection is performed as usual.
Main outcome variables
the pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191217045772N1
Registration date:2020-04-22, 1399/02/03
Registration timing:retrospective
Last update:2020-04-22, 1399/02/03
Update count:0
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
fatemeh saadati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 4385
Email address
saadati.f.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-24, 1398/10/03
Expected recruitment end date
2020-02-22, 1398/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dorsogluteal local pressure and Hugo's point massage with ice on pain sevirity due to intramuscular injection
Public title
Comparison of topical pressure and Hugo's point massage on pain of intramuscular injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1.Informed consent to participate in the research.
2. Lack of stiffness, tenderness, and lesion at the injection site according to the patient's report.
3. No severe illness and pain duo to disease according to the patient's report.
4. No injection in that area a week ago according to the patient's report.
5. being completely alert and able to respond and determine pain based on visual pain scale
6. Having the sense of hearing, vision.
7.ability to communicate.
8. No pain before intramuscular injection.
9. Age between 18 and 50
10. do not recive opioid and non-opioid painkiller in 2 hours before injection.
11. Don't be pregnant.
Exclusion criteria:
1. Any new medical conditions that restrict muscle infusion or affect patients' pain.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Sample allocation will be done by ABC by random assignment of permutation blocks with triple blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Gonabad, Asian Road Margin, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691167975
Approval date
2019-08-02, 1398/05/11
Ethics committee reference number
IR.GMU.REC.1398.081
Health conditions studied
1
Description of health condition studied
Factors Influencing Health Status and Contacting Health Services
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain caused by intramuscular injection
Timepoint
Immediately after the intramuscular injection
Method of measurement
Visual scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
For intervention group 1, a local pressure with thumb to the injection site applied until the patient feels pain for 10 seconds, then inject immediately.
Category
Prevention
2
Description
For intervention group 2, Hugo's point massage of right hand with ice wrapped in plastic glove and One layer cotton cloth was done Clockwise for 3 minutes, with soft and continuous pressure of 3 kg / m2, then massage is stopped for 30 seconds, and after that this intervention will be repeated twice
Category
Prevention
3
Description
Control group: In control group, injection is performed as usual.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Behlul Hospital of Gonabad
Full name of responsible person
ّّFatemeh Saadati Baghsiahy
Street address
Gonabad, Saadi St., Vahdat Boulevard
City
Gonabad
Province
Razavi Khorasan
Postal code
9691167975
Phone
+98 51 5723 4385
Email
Fateme.Saadati.66@Gmail.Com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr.Shahla Khosravan
Street address
Deputy of Research and Technology, Gonabad University of Medical Sciences, Asian Road, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691167975
Phone
+98 51 5723 4385
Email
fateme.saadati.66@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
ّّFateme Saadati Baghsiahy
Position
MSc in Internal Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad, Asian Road Margin, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691167975
Phone
+98 51 5723 4385
Email
Fatemeh.Saadati.66@Gmail.Com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Position
Member of Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gonabad, Asian Road Margin, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691167975
Phone
+98 51 5723 3028
Email
amohammadpur@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Saadati baghsiahy
Position
MSc Student of Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad, Asian Road Margin, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691167975
Phone
+98 51 5723 4385
Email
fatemeh.saadati.66@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available