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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725551
• Other study ID #: MU
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Children

Intervention

Device:
• ShotBlocker
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.

Other:
• Finger Puppet group
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
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".

Locations

Country	Name	City	State
Turkey	Mersin University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Fear Scale	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.	1 day
Primary	Facial Pain Scale	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.	1 day
Primary	Visual Analog Scale	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.	1 day