The Effects of Different Methods Used in Pediatric Oral Drug Administration

NCT ID: NCT06251245

Last Updated: 2025-03-05

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-06-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Children, Only Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental Group (Oral Injector)

Children who use oral injectors to give oral medication will constitute the experimental group.

Group Type EXPERIMENTAL

Oral Injector

Intervention Type PROCEDURE

* 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

Control group (Spoon)

Children who use spoons to give oral medication will constitute the control group.

Group Type OTHER

Spoon

Intervention Type PROCEDURE

* 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Kan Onturk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Acıbadem Health Group, Ataşehir Hospital

Istanbul, Ataşehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Akram G, Mullen AB. Paediatric nurses' knowledge and practice of mixing medication into foodstuff. Int J Pharm Pract. 2012 Jun;20(3):191-8. doi: 10.1111/j.2042-7174.2011.00179.x. Epub 2011 Nov 9.

Reference Type BACKGROUND
PMID: 22554162 (View on PubMed)

Alessandrini E, Walsh J, Salunke S. Usability of administration devices for oral and respiratory medicines: Views from a UK primary school. Eur J Pharm Biopharm. 2022 Sep;178:150-158. doi: 10.1016/j.ejpb.2022.08.006. Epub 2022 Aug 17.

Reference Type BACKGROUND
PMID: 35987466 (View on PubMed)

Chiappini E, Venturini E, Remaschi G, Principi N, Longhi R, Tovo PA, Becherucci P, Bonsignori F, Esposito S, Festini F, Galli L, Lucchesi B, Mugelli A, Marseglia GL, de Martino M; Italian Pediatric Society Panel for the Management of Fever in Children. 2016 Update of the Italian Pediatric Society Guidelines for Management of Fever in Children. J Pediatr. 2017 Jan;180:177-183.e1. doi: 10.1016/j.jpeds.2016.09.043. Epub 2016 Oct 31.

Reference Type BACKGROUND
PMID: 27810155 (View on PubMed)

Talegaonkar S, Chitlangia A, Pradhan V, More S, Salunke S. Uncovering caregiver concerns: 5 key issues that still remain unresolved in administration of oral medicines for children in India. Eur J Pharm Biopharm. 2023 Jun;187:166-174. doi: 10.1016/j.ejpb.2023.03.009. Epub 2023 Mar 23.

Reference Type BACKGROUND
PMID: 36965592 (View on PubMed)

Turgut MA, Turkmen AS. The effect of lighted toy on reducing pain and fear during blood collection in children between 3 and 6 years: A randomized control trial. J Pediatr Nurs. 2023 May-Jun;70:111-116. doi: 10.1016/j.pedn.2023.02.009. Epub 2023 Mar 9.

Reference Type BACKGROUND
PMID: 36905910 (View on PubMed)

Other Identifiers

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ATADEK-2023/10

Identifier Type: -

Identifier Source: org_study_id

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