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

NCT ID: NCT05725551

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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ShotBlocker group

Pain in intramuscular injection It is a noninvasive, plastic tool used to reduce.

Group Type EXPERIMENTAL

ShotBlocker

Intervention Type 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

Finger puppetry is an alternative method of interacting with the child through play while performing an intramuscular injection.

Group Type EXPERIMENTAL

Finger Puppet group

Intervention Type 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

Balloon inflation method, the child inflating the balloon while performing an intramuscular injection.

Group Type EXPERIMENTAL

Balloon group

Intervention Type 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".

Control Group

Intramuscular injection without any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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".

Intervention Type OTHER

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".

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Children who did not volunteer to participate in the study
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Didem Lafci

Dr. Faculty Member,pHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diğdem Lafcı pHD

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

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Mersin University

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MU

Identifier Type: -

Identifier Source: org_study_id

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