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

Sponsor
Mersin University (Other)
Overall Status
Completed
CT.gov ID
NCT05725551
Collaborator
(none)
148
1
4
3
49.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ShotBlocker
  • Other: Finger Puppet group
  • Other: Balloon group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Three Applıed Durıng Intramuscular Injectıon In Chıldren Effect Of Dıfferent Method On Paın And Fear
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Oct 1, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ShotBlocker group

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

Device: 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.

Experimental: Finger Puppet group

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

Other: 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".

Experimental: Balloon group

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

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".

No Intervention: Control Group

Intramuscular injection without any intervention.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mersin University Mersin Turkey 33110

Sponsors and Collaborators

  • Mersin University

Investigators

  • Principal Investigator: Diğdem Lafcı pHD, Mersin University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Didem Lafci, Dr. Faculty Member,pHD, Mersin University
ClinicalTrials.gov Identifier:
NCT05725551
Other Study ID Numbers:
  • MU
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 13, 2023