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Completed

NCT Number: NCT05725551

The Effect of Shotblocker, Finger Puppet And Balloon Method During Intramuscular Injection

The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on children's pain and fear level.

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Key information

Conditions

Children

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Mersin, 33110, Turkey (Türkiye)

About this study

The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on 7-12 age group children on pain and fear level.

The purpose of the research and all the working processes were explained to the children and parents by the researcher.

Children who met all eligibility criteria were invited to participate in the study with their parents.

The children and their parents were informed about the study, they were included in the study by announcing that they would be in one of the four groups, and this group was randomly determined.

Before starting the application, verbal and written consent was obtained from the parents of the children by reading/reading the Informed Voluntary Consent Form.

The child and parent were informed by the researcher about the pain and fear level assessment tools and application before and after the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children who volunteered to participate in the study and who met the inclusion criteria

Exclusion criteria

  • Children who did not volunteer to participate in the study

Treatment and study plan

ShotBlocker

Device

Before the procedure, the protruding surface of the vehicle was placed on the injection site in contact with the skin and used by holding it during injection. The level of pain and fear experienced by the child during and 5 minutes after the injection was evaluated with the "Facial Expressions Pain Scale" and "Visual Comparison Scale", and the level of fear was evaluated with the "Child Fear Scale" by the child, the parent accompanying the child, and the observer.

Finger Puppet group

Other

During the interaction between the finger puppet and the child, an intramuscular injection was made. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale".

Balloon group

Other

An intramuscular injection was given when the child began to inflate the balloon. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale".

Primary outcomes

  1. Child Fear Scale

    Time frame: 1 day

    The scale is a visual measurement tool consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety) and scores between 0-4 points.The level of pain experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.

  2. Facial Pain Scale

    Time frame: 1 day

    Graded according to the severity of the pain, the leftmost face consists of "no pain" and the rightmost face consists of a total of 6 facial expressions, such as "too much pain". Faces expressing the increase in pain intensity from left to right are scored as 0,2,4,6,8,10, respectively.The level of fear experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.

  3. Visual Analog Scale

    Time frame: 1 day

    The scale consists of a 10 cm / 100 mm long ruler that can be used horizontally or vertically, with "no pain" at one end and "worst pain imaginable" at the other. The child is asked to mark a spot on the line that will accurately reflect his or her pain.The level of pain experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

Three Applıed Durıng Intramuscular Injectıon In Chıldren Effect Of Dıfferent Method On Paın And Fear

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 13, 2023
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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