The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction
1 other identifier
interventional
208
1 country
1
Brief Summary
The research was conducted as a single-blind, randomized controlled, experimental study to determine the effect of ShotBlocker and local cold application on pain and patient satisfaction in subcutaneous heparin injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Jan 2022
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedFirst Submitted
Initial submission to the registry
August 12, 2024
CompletedFirst Posted
Study publicly available on registry
August 21, 2024
CompletedAugust 21, 2024
August 1, 2024
2 years
August 12, 2024
August 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual analog scale
The VAS is used to assess the severity of acute pain. It is mostly a horizontal or vertical line 100 mm long, starting with "no pain" and ending with "unbearable pain". It is used to convert some values that cannot be measured numerically to a numerically usable form
At the first minute after the injection, the patients were evaluated about the pain they felt during the injection by a different reseacher.
Secondary Outcomes (1)
Visual patient satisfaction scale
At the first minute after the injection, the patients were evaluated their satisfaction with the injection by a different reseacher.
Study Arms (4)
ShotBlocker group
EXPERIMENTALA ShotBlocker was placed on the arm of the patients in the ShotBlocker group during the injection, and the injection was performed from the part where the opening was located by lightly pressing with the fingertips throughout the injection.
ShotBlocker placebo group
EXPERIMENTALDuring the injection, the back side of the ShotBlocker was placed on the arm of the patients in the ShotBlocker placebo group and the injection was performed by gently pressing with the fingertips throughout the injection.
Local cold application group
EXPERIMENTALLocal cold application was applied to the arm of the patients in the local cold application group for five minutes using a cold pack,and then the injection was performed.
control group
NO INTERVENTIONPatients in the control group were injected with a routine subcutaneous injection procedure.
Interventions
A ShotBlocker was placed on the arm of the patients in the ShotBlocker group during the injection, and the injection was performed from the part where the opening was located by lightly pressing with the fingertips throughout the injection.
Local cold application was applied to the arm of the patients in the local cold application group for five minutes using a cold pack, and then the injection was performed.
During the injection, the back side of the ShotBlocker was placed on the arm of the patients in the ShotBlocker placebo group and the injection was performed by gently pressing with the fingertips throughout the injection.
Eligibility Criteria
You may qualify if:
- Enoxaparin sodium 1x1 0.6 ml. SC treatment
- Over 18 years of age
- No vision or hearing problems
- No scar tissue, incision, lipodystrophy or infection at the injection site
You may not qualify if:
- Underwent mastectomy
- Not being voluntering
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ege university nursing faculty
Izmir, Bornova, 35360, Turkey (Türkiye)
Related Publications (3)
Usach I, Martinez R, Festini T, Peris JE. Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site. Adv Ther. 2019 Nov;36(11):2986-2996. doi: 10.1007/s12325-019-01101-6. Epub 2019 Oct 5.
PMID: 31587143BACKGROUNDWang H, Guan J, Zhang X, Wang X, Ji T, Hou D, Wang G, Sun J. Effect of Cold Application on Pain and Bruising in Patients With Subcutaneous Injection of Low-Molecular-Weight Heparin: A Meta-Analysis. Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029620905349. doi: 10.1177/1076029620905349.
PMID: 32372652BACKGROUNDWoodley WD, Morel DR, Sutter DE, Pettis RJ, Bolick NG. Clinical evaluation of large volume subcutaneous injection tissue effects, pain, and acceptability in healthy adults. Clin Transl Sci. 2022 Jan;15(1):92-104. doi: 10.1111/cts.13109. Epub 2021 Nov 10.
PMID: 34268888BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research assistant faculty of nursing principles
Study Record Dates
First Submitted
August 12, 2024
First Posted
August 21, 2024
Study Start
January 1, 2022
Primary Completion
December 31, 2023
Study Completion
April 30, 2024
Last Updated
August 21, 2024
Record last verified: 2024-08