The Effects of Different Methods Used in Pediatric Oral Drug Administration

March 3, 2025 updated by: Zehra Kan Onturk, Acibadem University

The Effects of Different Methods Used in Oral Drug Administration on Fear in Children with Fever

The aim of this study is to determine the effect of the use of spoons and oral injectors on the level of fear in children with fever in oral medication administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fever is known as a defense mechanism of the body; Increased body temperature in children is one of the symptoms that frighten parents and is among the most common reasons for hospitalization. Pharmacological agents such as paracetamol and ibuprofen are often used in fever management, and if possible, oral administration of the suspension form of the drugs is preferred to reduce invasive practices. However, reasons such as children not liking the taste of the medicine, rejecting the medicine, or spitting or vomiting may cause difficulties in administering the medicine orally. More than one different method is used to administer these drugs, depending on the patient's age, general condition and compliance with the treatment. These; They can be listed as spoon, oral injector, medicine glass. As a result of the examination of the drug administration materials, it was stated that children are fear of the injector when the drugs are given with a injector, they may aspirate, and they do not have appropriate equipment to administer the drug. It is important for nurses to understand children's fears and their causes, to develop interventions to reduce fear, and to minimize possible traumatic effects during the hospitilization process.

In this study, the sample will be divided into two groups: experimental and control, and oral antipyretic medicine will be given by two different methods. An oral injector will be used in the experimental group and an oral medicine spoon will be used in the control group.

Hypotheses of the Study:

H0: There is no significant difference in the effect of the use of spoons and oral injectors in oral medication administration in children on the level of fear in children and parents.

H1: There is a significant difference in the fear level of using spoons and oral injectors in oral medication administration in children.

H2: There is a significant difference in the parents' fear level of using spoons and oral injectors in oral medication administration in children.

H3: There is a significant difference in the heart rate and oxygen saturation of children using spoons and oral injectors for oral medication administration.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ataşehir
      • Istanbul, Ataşehir, Turkey, 34750
        • Acıbadem Health Group, Ataşehir Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 3-6 and their parents,
  • Children with fever,
  • Children who have been ordered to take oral medication for fever in their treatment,
  • Able to express himself cognitively,
  • Able to speak and understand Turkish

Exclusion Criteria:

  • Children who have a disease that may prevent them from expressing their fear
  • It is time for the child to sleep at the time of medication administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (Oral Injector)
Children who use oral injectors to give oral medication will constitute the experimental group.
Procedure: Oral Injector
  • Admission of a child with fever to the pediatric inpatient ward
  • Obtaining parental consent
  • Completing the patient identification data collection form
  • Obtaining the child's consent
  • Applying the "Child Fear Scale" to the child
  • Measuring the child's pulse and SpO2
  • Applying the "Child Fear Scale" to the parent
  • Explaining the procedure using the educational therapeutic play method before oral medication administration
  • Administering the "Child Fear Scale" to the child and parent before oral medication administration
  • Measurement of the child's pulse and SpO2
  • • Experimental Group (Giving the medicine orally to the child with an Oral Injector)
  • Application of the "Child Fear Scale" to the child and parent after oral medication administration
  • Measurement of the child's pulse and SpO2
Other: Control group (Spoon)
Children who use spoons to give oral medication will constitute the control group.
Procedure: Spoon
  • Admission of a child with fever to the pediatric inpatient ward
  • Obtaining parental consent
  • Completing the patient identification data collection form
  • Obtaining the child's consent
  • Applying the "Child Fear Scale" to the child
  • Measuring the child's pulse and SpO2
  • Applying the "Child Fear Scale" to the parent
  • Explaining the procedure using the educational therapeutic play method before oral medication administration
  • Administering the "Child Fear Scale" to the child and parent before oral medication administration
  • Measurement of the child's pulse and SpO2
  • Control Group (Giving the medicine orally to the child with an oral medication spoon)
  • Application of the "Child Fear Scale" to the child and parent after oral medication administration
  • Measurement of the child's pulse and SpO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the child's fear level
Time Frame: at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed
Child Fear Scale is used to measure the level of fear in children. This scale consists of five different facial expressions ranging from 0 = this face is not afraid at all to 4 = the most fear possible. The child and the parents are asked to look at these faces and choose the most appropriate expression to describe their fear. It is used in both children and parents to evaluate fear before and during the procedure
at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed
Change in parent's fear level
Time Frame: at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed
Child Fear Scale is used to measure the level of fear in children. This scale consists of five different facial expressions ranging from 0 = this face is not afraid at all to 4 = the most fear possible. The child and the parents are asked to look at these faces and choose the most appropriate expression to describe their fear. It is used in both children and parents to evaluate fear before and during the procedure
at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed
Change in child's heart rate
Time Frame: at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed
This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor.
at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed
Change in child's oxygen saturation
Time Frame: at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed
This outcome obtained with patient monitor.
at the time of admission to the hospital, immediately before oral medication administration, immediately after medication administration. The change in these time intervals will be assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Actual)

June 16, 2024

Study Completion (Actual)

June 16, 2024

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATADEK-2023/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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