Clinical trial NCT06563648: The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction
Official title: The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Satisfaction, Patient
Keywords: Subcutaneous injection
shotblocker
cold application
low molecular weight heparin
pain
satisfaction
Lead sponsor: Bornova No. 25 Mevlana Family Health Center
Sponsor class: OTHER
Collaborators: name: Ataturk Training and Research Hospital
First posted: 2024-08-21
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Detailed description: 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. The research was conducted with 208 patients hospitalized in the Cardiology and Internal Medicine clinics at Izmir Atatürk Training and Research Hospital between April 2022 and April 2024. Patients were assigned to four groups: ShotBlocker (n=52), ShotBlocker placebo (n=52), local cold application (n=52) and control (n=52) groups using the randomization algorithm.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Underwent mastectomy
* Not being voluntering

Primary outcomes:
measure: Visual analog scale
timeFrame: 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:
measure: Visual patient satisfaction scale
timeFrame: At the first minute after the injection, the patients were evaluated their satisfaction with the injection by a different reseacher.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege university nursing faculty
state: Bornova
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.