A Comparison of Two Different Methods to Reduce Intramusculer Injection Pain

Healthy Clinical Trial

Official title:

A Comparison of Two dıfferent Methods to Reduce ıntramuscular ınjectıon paın; Cold Spray and ShotBlocker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634942
• Other study ID #: 2020/30
• Status: Completed
• Phase: N/A
• Start date: February 25, 2010
• Est. completion date: August 15, 2020

Study information

• Verified date: November 2020
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. In this study, it was used to reduce pain associated with IM injection in adults.

It was aimed to evaluate the effect of ShotBlocker and cold spray application on pain. The research is planned to be completed between February 2020 and December 2020. The universe of the study, which was conducted as a randomized controlled trial model, consisted of all adult patients who received diclofenac sodium treatment in Malatya Turgut Özal Medical Center Emergency Service. 195 patients selected by the simple random sampling method (shotBlocker group = 39, shotBlocker placebo = 39 spray groups = 39, spray group placebo = 39, control group = 39) were included in the study. Participant Introduction Form and Visual Benchmarking Scale (VAS) were used to collect data. According to the characteristics of the data In independent groups, t test, ANOVA test, Mann Whitney U test, correlation were measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: August 15, 2020
• Est. primary completion date: July 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being 18 years or older

• Communication,

• Having no problems with vision and hearing,

• No pain, scar tissue, incision, lipodystrophy and signs of infection in the application area,

• Body mass index between 18.5 and 30,

• There is no history of allergy.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Malatya Turgut Ozal Medical Center	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of cold spray on intramuscular pain	The Visual Benchmark Scale (VAS) is a two-tailed 10 cm long scale used to measure pain, expressed by minimum no pain (0) and maximum very severe pain (10). Within 2 minutes of completing the injection, the individual was asked to mark his pain on the The Visual Benchmark Scale (VAS).	About 2 months
Primary	The effect of ShotBlocker on intramuscular pain	The Visual Benchmark Scale (VAS) is a two-tailed 10 cm long scale used to measure pain, expressed by minimum no pain (0) and maximum very severe pain (10). Within 2 minutes of completing the injection, the individual was asked to mark his pain on the The Visual Benchmark Scale (VAS).	About 2 months