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

Not Applicable

Completed

• Conditions: Children
• Interventions: Other: Finger Puppet group; Device: ShotBlocker; Other: Balloon group

• Registration Number: NCT05725551
• Lead Sponsor: Mersin University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-31
• Study First Submitted: 2023-01-12
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-13
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Finger Puppet group	Finger Puppet group	Finger puppetry is an alternative method of interacting with the child through play while performing an intramuscular injection.
ShotBlocker group	ShotBlocker	Pain in intramuscular injection It is a noninvasive, plastic tool used to reduce.
Balloon group	Balloon group	Balloon inflation method, the child inflating the balloon while performing an intramuscular injection.

Primary Outcome Measures

Name	Time	Method
Facial Pain Scale	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.
Visual Analog Scale	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.
Child Fear Scale	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.

Trial Locations

Locations (1)

Mersin University; 🇹🇷 Mersin, Turkey