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Completed

NCT Number: NCT06563648

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

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege university nursing faculty

Izmir, Bornova, 35360, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

shotblocker

Other

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

Other

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

Other

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.

Primary outcomes

  1. Visual analog scale

    Time frame: At 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 outcomes

  1. Visual patient satisfaction scale

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

Bornova No. 25 Mevlana Family Health Center

Other

Collaborators

  • Ataturk Training and Research Hospital

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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