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A Comparison of Two Different Methods to Reduce Intramusculer Injection Pain

NCT04634942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2020-11-18

No results posted yet for this study

Summary

When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.

The aim of the study is to use it to reduce pain associated with IM injection in adults.

To evaluate the effect of cold spray and ShotBlocker applications on pain.

Conditions

  • Healthy

Interventions

DEVICE

Cryos REF 0971 Cold Spray

Cold Spray Coolant spray is manufactured from liquefied gases with high pressure. It acts by rapidly reducing the temperature in the body area where it is applied. The liquefied gas in the tube spreads on the skin in liquid form and takes the heat of the skin by turning into gas. The temperature of the area where it is applied drops from 30-32 degrees to 10-15 degrees. With the effect of the cold, the excitability of the nerve endings decreases, and thus the pain on the skin is felt by the person. Cold sprays, whose analgesic effect occurs immediately, are applied parallel to the muscle fibers in the area to be applied, from a distance of 15-45 centimeters, by squeezing for approximately 5-15 seconds. Cold sprays are suitable for long-term and multiple uses.

DEVICE

ShotBlocker BIONIX Press Firmly USA

ShotBlocker ShotBlocker is a plastic tool with a small and flat shape, with short and non-sharp protrusions on one side that connect with the skin. It resembles a horseshoe (C shaped) with its structure designed to expose the area to be injected. It is suitable for all age groups. It does not have any side effects. ShotBlocker can be used for both intramuscular and subcutaneous injections. The protruding surface of the ShotBlocker is held by pressing the skin during the injection and the process is performed from the part where the opening is.

Sponsors & Collaborators

  • Inonu University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-25
Primary Completion
2020-07-11
Completion
2020-08-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04634942 on ClinicalTrials.gov