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

August 19, 2024 updated by: Merve Ince, Bornova No. 25 Mevlana Family Health Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey, 35360
        • Ege University Nursing Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Experimental: 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.
Other: 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.
Experimental: 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.
Other: 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.
No Intervention: control group
Patients in the control group were injected with a routine subcutaneous injection procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the first minute after the injection, the patients were evaluated about the pain they felt during the injection by a different reseacher.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the first minute after the injection, the patients were evaluated their satisfaction with the injection by a different reseacher.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bornova No. 25 Mevlana Family Health Center

Collaborators

Ataturk Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ege (Other Identifier: ege)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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