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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05725551
Enrollment
148
Registered
2023-02-13
Start date
2022-10-01
Completion date
2022-12-31
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children

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.

Interventions

DEVICEShotBlocker

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.

OTHERFinger 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.

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.

Sponsors

Mersin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Child Fear Scale1 dayThe 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.
Facial Pain Scale1 dayGraded 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 Scale1 dayThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026