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Clinical Trials/NCT05725551
NCT05725551
Completed
Not Applicable

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

Mersin University1 site in 1 country148 target enrollmentOctober 1, 2022
ConditionsChildren

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Children
Sponsor
Mersin University
Enrollment
148
Locations
1
Primary Endpoint
Facial Pain Scale
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Didem Lafci

Dr. Faculty Member,pHD

Mersin University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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