The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction
NCT ID: NCT06563648
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
208 participants
INTERVENTIONAL
2022-01-01
2024-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of SHOTBLOCKER
NCT06956066
Efficacy of Shotblocker in Spinal Needle Related Pain
NCT03554122
The Effect of ShotBlocker on Injection Pain
NCT05495542
ShotBloker and Helfer Skin Tap Technique During Intramuscular Injection in Children
NCT05563233
Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.
NCT04436185
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. 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. 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. Patients in the control group were injected with a routine subcutaneous injection procedure. In all groups, the injection took 30 seconds and was performed by researcher. At the first minute after the injection, the patients were evaluated about the pain they felt during the injection and their satisfaction with the injection by a different reseacher. Data were collected by face-to-face interview technique using an informed consent form, individual identification form, visual analog scale and visual patient satisfaction scale. Ethics committee permission, institutional permission and written permission from the patients were obtained for the implementation of the research. Number, percentage, median, mean, and standard deviation, Mann Whitney U test, Kolmogorov-Smirnov test, Kruskal Wallis H test, Bonferroni and chi-square test were used in the analysis of the data.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ShotBlocker group
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.
shotblocker
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.
ShotBlocker placebo group
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.
ShotBlocker placebo group
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.
Local cold application group
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.
local cold application
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.
control group
Patients in the control group were injected with a routine subcutaneous injection procedure.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
shotblocker
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
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.
ShotBlocker placebo group
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Over 18 years of age
* No vision or hearing problems
* No scar tissue, incision, lipodystrophy or infection at the injection site
Exclusion Criteria
* Not being voluntering
18 Years
95 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ataturk Training and Research Hospital
OTHER
Bornova No. 25 Mevlana Family Health Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Merve Ince
research assistant faculty of nursing principles
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ege university nursing faculty
Izmir, Bornova, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Wang 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.
Woodley 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ege
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.