A Comparison of Two Different Methods to Reduce Intramusculer Injection Pain

Inonu University

Status: Completed

Conditions: Healthy

Treatments: Device: ShotBlocker BIONIX Press Firmly USA; Device: Cryos REF 0971 Cold Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04634942

2020/30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

195 participants in 5 patient groups, including a placebo group

Cold Spray Group

Experimental group

Description:

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.

Treatment:

Device: Cryos REF 0971 Cold Spray

ShotBlocker Group

Experimental group

Description:

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.

Treatment:

Device: ShotBlocker BIONIX Press Firmly USA

Control Group

No Intervention group

Description:

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.

Cold Spray Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Device: Cryos REF 0971 Cold Spray

ShotBlocker Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Device: ShotBlocker BIONIX Press Firmly USA