Clinical trial NCT04634942: A Comparison of Two Different Methods to Reduce Intramusculer Injection Pain
Official title: A Comparison of Two dıfferent Methods to Reduce ıntramuscular ınjectıon paın; Cold Spray and ShotBlocker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Intramuscular Injection
Pain
Cold Spray
ShotBlocker
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: The effect of cold spray on intramuscular pain
timeFrame: About 2 months
measure: The effect of ShotBlocker on intramuscular pain
timeFrame: About 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Malatya Turgut Ozal Medical Center
Study officials:
References: