Comparison of the effect of shot blocker and vibration on the intensity of pain and bruising caused by enoxaparin injection in cardiac patients.
Design
120 heart patients hospitalized in Ferdous Hospital will be selected by the available method and will be randomly allocated into three groups of shot blocker intervention, vibration intervention and control.
Settings and conduct
On cardiac patients hospitalized in Ferdous Hospital in 2023
Participants/Inclusion and exclusion criteria
Age 40 to 65 years old; no neuromuscular disease; no skin disease, known coagulation disorder, no type 1 or type 2 diabetes treated with insulin; no swelling, wound, scratch and redness in the injection area and body mass index between 18.5 30.
The exit criteria: death of the patient; discharge of the patient before 48 hours; receipt of anti-coagulant medication for any reason, and the need for subcutaneous injection other than enoxaparin in the abdominal and arm areas.
Intervention groups
The control gather will as it were get the normal care, but in one gather, shot blocker will be utilized and within the other bunch, vibration will be utilized some time recently infusion. The nurture keeps the shot blocker and the vibrating gadget in put for 5 seconds some time recently the infusion and the infusion tapayan does not discharge the weight. Individuals with two enoxaparin infusions in 24 hours are chosen. The infusion is done for all patients 5 cm around the navel and the infusion method is 30 seconds.
Main outcome variables
Intensity of pain; severity of bruising
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240430061604N3
Registration date:2024-07-05, 1403/04/15
Registration timing:retrospective
Last update:2024-07-05, 1403/04/15
Update count:0
Registration date
2024-07-05, 1403/04/15
Registrant information
Name
maryam mokhtariseghaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3289 3005
Email address
maryammoktari3ghale@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-16, 1402/12/26
Expected recruitment end date
2024-06-15, 1403/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of shot blocker and vibration on the intensity of pain and bruising caused by enoxaparin injection heart patient
Public title
The effect of shot blocker and vibration on the intensity of pain and bruising caused by enoxaparin injection heart patient
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 65 years old
No neuromuscular disease
No skin disease, known coagulation disorder, no type 1 or type 2 diabetes treated with insulin
No swelling, wound, scratch and redness in the injection area
Body mass index between 18.5 30
If there is a venous sampling, it will not interfere with the time of enoxaparin injection and will not affect the pain level caused by the injection
Will not receive another drug through subcutaneous injection
Exclusion criteria:
Death of the patient
Patient discharge before 48 hours
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks will be randomly allocated in three groups: shot blocker intervention, vibration intervention and control.
Blocked randomization is for the purpose of making sure that exactly equal number of participants are included in the intervention and control group at consecutive but equal time intervals. The size of each block can be 5, 10, 16 to 20 people. In this way, for example, one type of treatment is given to the first block and another type to the second, and again the first type to the third block and so on.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Shot blocker and vibration have not been used to prevent pain and bruising caused by enoxaparin, and in previous studies, most of the population was studied in children.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
9771853975
Approval date
2024-03-15, 1402/12/25
Ethics committee reference number
IR.BUMS.REC.1402.558
Health conditions studied
1
Description of health condition studied
Ischemic Heart patients
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
Severity of pain and bruising
Timepoint
Intensity of pain caused by enoxaparin injection in cardiac patients of shot blocker, vibration and control groups at the time of injection.
Method of measurement
Visual scale for measuring pain intensity
Secondary outcomes
empty
Intervention groups
1
Description
A shot blocker will be used in one group. The nurse will keep the shot blocker in place for 5 seconds before the injection, and the injection needle will not release the pressure. People with two enoxaparin injections in 24 hours will be selected, injection for all patients within 5 cm. The navel is performed and the injection technique is 30 seconds and the needle remains in the subcutaneous space for 5 seconds, and then it is removed by a fixed nurse using the prepared enoxaparin syringes with a volume of 4 tenths and 6 tenths of a milliliter and a needle head number 27 with an air lock of 2 tenths And it will be done with a 90 degree angle and without aspiration, and a fixed cornometer is used during the injection.Pain will be measured immediately after injection and 5 minutes after injection, and bruising will be measured immediately after injection and 24 and 48 hours after injection.
Category
Prevention
2
Description
In one group, vibration will be used before injection. The nurse keeps the vibrating device in place for 5 seconds before the injection and does not release the injection pressure. People with two enoxaparin injections in 24 hours are selected. The injection is done for all patients 5 cm around the navel, and the injection technique is 30 seconds and the needle. It remains in the subcutaneous space for 5 seconds and then it is removed by a steady nurse using prepared enoxaparin syringes with a volume of 4 tenths and 6 tenths of a milliliter and a needle head number 27 with a 2 tenths air lock at a 90 degree angle and without aspiration. and a fixed cornometer is used during the injection.Pain will be measured immediately after injection and 5 minutes after injection, and bruising will be measured immediately after injection and 24 and 48 hours after injection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Maryam Mokhtari Seghaleh
Street address
Islamia Ferdous Road
City
Ferdows
Province
South Khorasan
Postal code
9771853975
Phone
+98 56 3162 7300
Email
maryammoktari3ghale@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein safarpoor
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
9771853975
Phone
+98 56 3162 5000
Email
BUMS.AC@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Maryam Mokhtari seghaleh
Position
Employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Motahari Street, Chamran Hospital, Faculty of Medical Sciences
City
Ferdows
Province
South Khorasan
Postal code
9771853975
Phone
+98 56 3162 7300
Email
maryammoktari3ghale@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Mokhtari seghaleh
Position
employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Medical Sciences. Chamran Hospital, Shahid Motahari Street
City
Ferdows
Province
South Khorasan
Postal code
9771853975
Phone
+98 56 3162 7300
Email
maryammoktari3ghale@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Mokhtari seghaleh
Position
Employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Medical Sciences. Chamran Hospital, Shahid Motahari Street
City
Ferdows
Province
South Khorasan
Postal code
9771853975
Phone
+98 56 3162 7300
Email
maryammoktari3ghale@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD