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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Pain Satisfaction, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

shotblocker

Intervention Type 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.

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.

Group Type EXPERIMENTAL

ShotBlocker placebo group

Intervention Type 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.

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.

Group Type EXPERIMENTAL

local cold application

Intervention Type 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.

control group

Patients in the control group were injected with a routine subcutaneous injection procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk Training and Research Hospital

OTHER

Sponsor Role collaborator

Bornova No. 25 Mevlana Family Health Center

OTHER

Sponsor Role lead

Responsible Party

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Merve Ince

research assistant faculty of nursing principles

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege university nursing faculty

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31587143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32372652 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34268888 (View on PubMed)

Other Identifiers

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Ege

Identifier Type: -

Identifier Source: org_study_id

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