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

NCT05725551 | Completed

• 1 other identifier: MU
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Children

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (4)

ShotBlocker group

EXPERIMENTAL

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

Device: ShotBlocker

Finger Puppet group

EXPERIMENTAL

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

Other: Finger Puppet group

Balloon group

EXPERIMENTAL

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

Other: Balloon group

Control Group

NO INTERVENTION

Intramuscular injection without any intervention.

Interventions

ShotBlocker 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.

ShotBlocker group

Finger Puppet group 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".

Finger Puppet group

Balloon group 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".

Balloon group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Children who did not volunteer to participate in the study

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, 33110, Turkey (Türkiye)

Location

Study Officials

• Diğdem Lafcı pHD

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Faculty Member,pHD

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 13, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)