CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Cold application group +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05070325
NCT05070325N/ACompleted

Shotblocker or Cold Application; Which One is More Effective in Reducing the Pain Associated With the Intramuscular Injection in Children: A Randomized Controlled Trial

Bandırma Onyedi Eylül University·interventional·Posted Oct 7, 2021·Updated Oct 15, 2021

In Brief

A clinical study evaluating Cold application group, Shotblocker group, and 1 other intervention for Child and 2 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed Summary

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of the methods of cold application and Shotblocker on the pain and anxiety level of the children in reducing the pain associated with the intramuscular injection. The hypotheses of the study: Hypothesis 0. Shotblocker and the cold application to the injection site prior to the injection are not effective in reducing the pain associated with the intramuscular injection in children. Hypothesis 1. Using ShotBlocker during the intramuscular injection reduces the pain and anxiety experienced by the child. Hypothesis 2. Applying cold to the injection site prior to the intramuscular injection reduces the pain and anxiety experienced by the child. This research was designed as a randomized controlled experimental study in a university hospital in Çorum. The sample of the study comprised 150 children aged 7 to 12 years who were brought to the pediatric injection room in a university hospital and had intramuscular injection. The children were randomized into the Shotblocker (n=50), cold application (n=50) and control (n=50) groups. In addition to Wong-Baker Pain Scale and Child Anxiety Scale, the Child Information Form was used in the study to determine the introductory characteristics of the children and their family.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 7, 2021
Enrollment StartNov 1, 2017
Primary CompletionJun 30, 2018
Study CompletionDec 20, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.7 years ago

Interventions

Cold application groupother

Cold application group (Group 1): In the children in this group, the injection site was cleaned before the injection using antiseptic cotton and then the gel pad was placed on the injection site. In line with the literature, the cold gel pad was applied to the intramuscular injection site for 30-45 seconds before the injection and then the injection was delivered. The children were told to breathe deeply and not to tense up during the injection.

Shotblocker groupother

Shotblocker group (Group 2): The injection site was cleaned using antiseptic cotton. The surface of the Shotblocker with the contact points was placed on the site just before the injection in a way not to contaminate the injection point. Injection was carried out through the opening in the middle of ShotBlocker. The children were told to breathe deeply and not to tense up during the injection. After the injection was completed, ShotBlocker was removed from the skin.

Control Groupother

Control Group (Group 3): The routine IM injection was applied to the children in this group. The injection site was cleaned using antiseptic cotton. The children were told to breathe deeply and not to tense up during the injection.