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The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction

The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06563648
Enrollment
208
Registered
2024-08-21
Start date
2022-01-01
Completion date
2024-04-30
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Satisfaction, Patient

Keywords

Subcutaneous injection, shotblocker, cold application, low molecular weight heparin, pain, satisfaction

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.

Interventions

OTHERshotblocker

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.

OTHERShotBlocker 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.

Sponsors

Ataturk Training and Research Hospital
CollaboratorOTHER
Bornova No. 25 Mevlana Family Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scaleAt the first minute after the injection, the patients were evaluated about the pain they felt during the injection by a different reseacher.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

Secondary

MeasureTime frameDescription
Visual patient satisfaction scaleAt the first minute after the injection, the patients were evaluated their satisfaction with the injection by a different reseacher.The visual patient satisfaction scale combines the characteristics of the well-known VAS. At one end of the scale is the phrase I am not satisfied at all, and at the other end is the phrase I am very satisfied. It is mostly a horizontal or vertical line 100 mm long.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026