MedDataX Logo

A Comparison of Two Different Methods to Reduce Intramusculer Injection Pain

NCT ID: NCT04634942

Last Updated: 2020-11-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-25

Study Completion Date

2020-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Intramuscular Injection Pain Cold Spray ShotBlocker

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In the study, the randomization method was used to assign the patients to the groups to prevent manipulations that could be done consciously or unconsciously. A computer-assisted randomization program was used to make assignments to the groups. A random list was created in the computer environment by using random.org, assigning individuals to groups (117). 195 people, who will form the sample of the study, were divided into sets of 39, and sets were created by assigning numbers from 1 to 5 to each set. When the sets were obtained, the numbers from 1 to 5 were written on small papers, and group assignments were made by lot method.

Group 1 = Control Group 2 = Cold Spray Placebo 3rd Group = Cold Spray 4th Group = ShotBlocker Group 5 = ShotBlocker Placebo
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cold Spray Group

Cold spray group injection process step; In addition to the IM injection procedure steps, Cryos cold spray was applied to patients in this group after skin cleansing. Cryos cold spray sprayed 3 puffs from a distance of 20 cm to the skin, and the injection process was performed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle while entering the tissue on the VAS.

Group Type EXPERIMENTAL

Cryos REF 0971 Cold Spray

Intervention Type DEVICE

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 Group

ShotBlocker group injection process step; In addition to the IM injection procedure steps, after cleansing the skin of the patients in this group, the protruding part of the ShotBlocker was placed in contact with the skin. ShotBlocker was pressed firmly against the skin and the injection was made through the central opening of the ShotBlocker. ShotBlocker was removed from the skin after the injection was completed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle while entering the tissue on the VAS.

Group Type EXPERIMENTAL

ShotBlocker BIONIX Press Firmly USA

Intervention Type DEVICE

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.

Control Group

Control group injection process step; The individuals in this group were injected by following the routine IM injection procedure steps. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle entering the tissue on the VAS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Cold Spray Placebo Group

Cold spray placebo group injection procedure step; In addition to the IM injection procedure steps, the patients in this group were treated with tap water in a cold spray bottle after cleansing the skin. After spraying 3 puffs of tap water in a placebo bottle at a distance of 20 cm to the skin, the injection was performed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle entering the tissue on the VAS.

Group Type PLACEBO_COMPARATOR

Cryos REF 0971 Cold Spray

Intervention Type DEVICE

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 Placebo Group

ShotBlocker placebo group injection procedure step; In addition to the IM injection procedure steps, in patients in this group, the non-protruding part of the ShotBlocker was placed in contact with the skin after skin cleaning. ShotBlocker was pressed firmly against the skin and the injection was applied through the central opening of the ShotBlocker. ShotBlocker was removed from the skin after the injection was completed.

Group Type PLACEBO_COMPARATOR

ShotBlocker BIONIX Press Firmly USA

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inonu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zeliha CENGİZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Malatya Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020/30

Identifier Type: -

Identifier Source: org_study_id